Atorvastatin+Amlodipine (Caudet): Ranbaxy launched authorized generic

The generic player Ranbaxy has launched the authorized generic version of Amlodipine+ Atorvastatin (Caudet) tablets in US market. This was confirmed by the generic pharma giant in following press release: http://www.ranbaxy.com/news/newsdisp.aspx?cp=988&flag=LN

Innovator Pfizer is currently marketing about 11 combination strenghts in US market (Amlodipine+Atorvastatin):

10+10, 10+20, 10+40, 10+80, 2.5+10, 2.5+20, 2.5+40, 5+10, 5+20, 5+40, 5+80 mg tablets

This launch was as per Ranbaxy's earlier settlement with innovator Pfizer. Earlier, Ranbaxy has challenged the innovator's combination patent on this combination US6455574, scheduled to expire on Aug 11, 2018.

Atorvastatin: Authorized generic arrived, Ranbaxy generic approved with help from Teva

The historic day for American public to welcome generic version of Blockbuster drug Atorvastatin hemicalcium tablets (Lipitor). In India, every person working in the Pharma industry was eagerly awaiting news about generic approval and launch by Ranbaxy. However, it was not clear that Ranbaxy would be able to launch the generic version till Nov 30 evening. However, Dec 1 morning in India bring good news for Ranbaxy and it was confirmed that Ranbaxy has been able to resolve the cGMP issues raised by USFDA against Ranbaxy's API and formulation manufacturing units located in India. The various news items confirmed that Ranbaxy has been able to get the approval from it's US subsidiary M/S Ohm lab. Earlier, some FTF products of Ranbaxy like Donepezil and Valacyclovir were launched from this facility only.

Launch with help from Teva: As per Ranbaxy's official press release the part of sale shall be shared with Teva which probably has helped Ranbaxy on resolving various technical issues with USFDA.
http://www.ranbaxy.com/news/newsdisp.aspx?cp=987&flag=LN

Other generic players: Earlier, the generic players like Actavis, Teva, Dr Reddy, Aurbindo, Mylan and few others have settled the patent litigation with innovator on crystalline form I patent and these companies have been eagerly awaiting the generic launch of Ranbaxy to subsequently launch their generic version after the expiry of 180 days exclusivity of Ranbaxy. These companies are expected to launch the generic version in first week of June, 2012.

Overall, this is a very good news for all the scientists of Ranbaxy who were instrumental in developing the generic version. As the Para IV filing was made about 8-10 years ago and some of those scientists may have been working in other organisations now. However, they will be very happy on this news and must be silently admiring this news.

Overall, a good finish in the end like a bollywood thriller.

Atorvastatin (Lipitor): The action begins in various markets

The richest molecule Atorvastatin is approching patent expiry in regulated market in US and EU and as the D-day is approching there has been new twists in activities by generic or innovator companies. The recent press releases have started disclosing their plans:
1. Innovator Pfizer revealed that they intend to make OTC switch.

2. Merck filed NDA on Ezetimibe+ Atorvastatin with USFDA. Although, Merck filed ANDA with amorphous form, innovator Pfizer promptly sued Merck for the infringement of crystalline polymorph patent scheduled to expire in Jan, 2017

3. To snub various generic companies, innovator Pfizer has asserted the polymorph patent against Mylan, Aurbindo, DRL and very recently against Macleods.

3. Lupin has alreday filed a suitability petition with USFDA for capsule version.

4. Cobalt prepared the strategy with sodium salt

5. The Teva is litigating in Europe for an early entry.

6. The Atorvastatin geneeric market first opened up in Canada and captured by around 8-10 players

7. The major bottleneck for the generic companies in US is Ranbaxy's FTF exclusivity and launch is expected by Nov 30, 2011. However, due to the regulatory problems of Ranbaxy there has been various speculations like Ranbaxy will delay the generic launch or they may share exclusivity with other player. The various generic players like Apotex and Mylan has been trying to trigger Ranbaxy's exclusivity without any success till date.

8. The Watson Pharma will launch an authorized generic verssion during Ranbaxy's FTF exclusivity.

9. The other players like Mylan, Kremer Urban, Apotex, Aurbindo, DRL and Macleods can be the other potrential player expected to launch in first week of June, 2012

Overall, IP Pharma Doc expect many more turns in events and will keep on updating the same on this blog

Donepezil (Aricept): 16 generic players got final approval after FTF expiry

About 16 players got final approval on Donepezil Hydrochloride 5 and 10 mg tablets for US market. Earlier, the First para IV filer Ranbaxy got final approval on Nov 26, 2010 after the expiry of compound patent.

After the FTF expiry on May 30, 2011, the USFDA approved generic version of this medication on May 31, 2011
1) Teva
2) Cipla
3) Mutual
4) Roxane
5) Aurbindo
6) Hikma
7) Sandoz
8) Pliva
9) Sun
10) Matrix
11) Actavis
12) Torrent
13) Jubilant
14) Wockhardt
15) Huahai
16) Dr Reddy

The sale of this molecule is about 3 billion USD.

IP Pharma Doc congratulate all the above players.

Pantoprazole Sodium (Protonix) patent issues Part II: Court Found Innovator's Key Patent Valid & Infringed by generic players

Refer to my earlier blog post on Pantoprazole Jury decision (http://ippharmdoc.blogspot.com/2010/04/pantoprazole-sodium-protonix-patent.html).

Now, the pharma giant Teva Pharma announced that the U.S. District Court for the District of New Jersey denied Teva's motion to overturn key patent US4758579 (Expiry: Jan 19, 2011) w.r.t jury verdict finding the patent in suit not invalid.

As per press release from innovator Nycomed, Judge Jose L. Linares of the U.S. District Court for the District of New Jersey has confirmed the jury verdict in favor of Nycomed and Pfizer Inc. The decision upholds the jury verdict issued on April 23, 2010, confirming that the patent is valid and rejecting allegations by the defendants that the patent was invalid as obvious and invalid for double patenting

The Court also denied Wyeth and Nycomed's request for FDA to reset the date of Teva's final approval to January 2011, based on the fact that Teva has patent inequitable conduct defenses remaining at the District Court, including patent misuse. Accordingly, Teva is not prohibited from making further sales prior to January 2011, the date when the pediatric exclusivity expires. The Court has not yet issued its underlying reasoning for today's decisions. Teva continues to believe the patent is invalid and unenforceable and intends to pursue all available legal remedies including appeals.

As per Nycomed press release, Nycomed now will continue to vigorously pursue its damage claims in this case, resulting from the launch of generic versions of Pantoprazole tablets at-risk by generic players Teva and Sun. The generic version by Teva was launched in Nov, 2007 and by Sun in Jan, 2008. The said launch was at risk launch.

Source: Press Releases By

1) Teva (http://www.tevapharm.com/pr/2010/pr_948.asp)

2) Nycomed (http://www.nycomed.com/News/News-Releases/2010/Nycomeds%20US%20patent%20for%20Protonix%20pantoprazole%20valid.aspx)

3) Sun (http://sunpharma.com/admin/news/upload/Protonix%200710.pdf)

Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg Tablets: Announces Settlement Agreement with innovator

Generic player Mylan announced that its subsidiary Matrix Laboratories Limited received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Further, Mylan has obtained approval on this important product on on July 20, 2010

Mylan also announced that it reached settlement and license agreements with Medicis resolving patent litigation relating to Minocycline ER, and the company has ceased additional distribution. Pursuant to the terms of the agreements, Medicis will release Mylan from any liability related to the prior sales of this product, and Mylan will have the right to market Minocycline ER in the U.S. beginning in November, 2011 or earlier under certain circumstances. Additional terms of the agreement were not disclosed.

Earlier, innovator has settled the patent litigation with generic player Teva, as reported earlier by this blog http://ippharmdoc.blogspot.com/2009/03/minocycline-hcl-solodyn-innovator.html

Minocycline ER had U.S. sales of approximately $496 million for the 12 months ending March 31, 2010, according to IMS Health.

Source: Mylan Press release http://investor.mylan.com/releasedetail.cfm?ReleaseID=491217

to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets: Mylan announced settlement with innovator

After settlement with generic player Lupin and others, the innovator Forest and Merz Pharma have settled the patent litigation w.r.t method of use patent U.S. Patent No. 5,061,703 (scheduled to expire in April, 2015) with generic player Mylan. Mylan has confirmed in a press release that that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets

As per agreement, Mylan will have the right to market Memantine HCl in the U.S. on Jan. 11, 2015, or earlier, under certain circumstances. Additional details of the agreement remain confidential and remain subject to review by the U.S. Department of Justice and the Federal Trade Commission (FTC).

Earlier, the various generic players like Barr Lab, Cobalt Lab, Lupin, Orchid, Teva Pharma, Upsher-Smith Lab, Genpharm, Sun, Ranbaxy and Wockhardt filed ANDA with Paragraph patent IV certification against ‘703 patent. Subsequently, innovator sued various generic players for the infringement of ‘703 patent in U.S. District Court for the District of Delaware.

Importantly, most of the generic players have settled the patent litigation with innovator. The some of generic players like Lupin, Mylan and others will enter almost 3 months prior to patent expiry.

Namenda had U.S. sales of $1.2 billion for the twelve months ending March 31, 2010, according to IMS Health.

Refer to my earlier posts on Namenda http://ippharmdoc.blogspot.com/2009/12/memantine-hydrochloride-namenda-tablets.html

Source: Press release of Mylan (http://investor.mylan.com/releasedetail.cfm?ReleaseID=490915)

Valacyclovir Hydrochloride (Valtrex) 500 mg and 1 g tablets: 8 generic players got final approval from USFDA

Following 8 generic players have obtained final approval to market generic version of Valacyclovir (Valtrex) 500 mg and 1 g tablets in US market:

1. Dr. Reddy's Laboratories

2. Mylan Pharmaceuticals Inc: http://investor.mylan.com/releasedetail.cfm?ReleaseID=473489
3. Matrix Laboratories Ltd.

4. Roxane Laboratories, Inc.

5. Sandoz Inc.,

6. Teva Pharmaceuticals USA: http://www.tevapharm.com/pr/2010/pr_936.asp

7. Watson Laboratories, Inc: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538

8. Aurobindo Pharma USA, Inc: http://www.aurobindo.com/

The above generic players have obtained final approval from USFDA after the expiry of Ranbaxy's 180 days FTF exclusivity on May 25, 2010.

Please refer to my earlier post on Ranbaxy’s FTF exclusivity http://ippharmdoc.blogspot.com/search?q=valacyclovir

Generic version of Atorvastatin Calcium tablets approved and launched in Canada

Various generic players have received the Notice of Compliance from Health Canada to market generic version of Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets in Canadian market.

The generic players like a) Apotex, b) Pharmascience, c) Teva, d) Sandoz, e) Watson, F) Cobalt, g) NovoPharm and h) Ratiopharm have received Notice of Compliance letters on this blockbuster formulation on May 19, 2009 (as per Health Canada website).

Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets had annual brand sales of approximately C$1.3 billion in Canada.

Innovator Pfizer has a key patent CA2021546 (Expiry: July 19, 2010), the said patent covers enantiomer of Atorvastatin as product. The various generic players have litigated with innovator on this patent and subsequently generic players settled with innovator (in Aug, 2008). As per press releases, 3 generic players namely Apotex, Teva and Watson have confirmed about the generic launch in the Canadian market. Importantly, these generic players have been able to enter into the Canadian market exactly 2 months before the blocking patent's expiry.

Further, generic players like Apotex, Teva and Watson have announced about the generic launch of this formulation in the following press releases:

Teva Press Release: http://www.tevapharm.com/pr/2010/pr_935.asp

Watson Press Release: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1429149

News about Ranbaxy's generic version: http://www.digitaljournal.com/pr/39611

Reuters news on the generic launch: tp://www.reuters.com/article/idUKN1924176320100519?type=companyNews

Losartan Potassium (Cozaar) and Losartan +HCTZ (Hyzaar/Cozaar Plus): Interesting decisions in US and EU

The generic players for Angiotensin Receptor Blocker (ARB) medicine Losartan Potassium (Cozaar) and Losartan + Hydrochlorthiazide (Hyzaar/Cozaar Plus) in the last 8-9 months have witnessed various interesting decisions in the courts, patent offices and regulatory agencies of US and Europe.

In US, generic player Teva secured First To File (FTF) 180 days exclusivity by challenging innovator Merck’s patent US5608075 (Expiry: Sep 4, 2009), which covers various polymorphic forms of Losartan Potassium. After Teva's ANDA filing, innovator Merck filed patent delisting request to USFDA on '075 patent. However, Teva opposed this delisting and after a long legal battle with USFDA in the court, Teva got exclusivity on this product. Also, generic players Roxane and Apotex challenged USFDA decision of grant of FTF 180 day’s exclusivity to Teva. The decision of US court and regulatory agency USFDA's decision has interesting discussion on patent delisting, Medicare Modernization act and FTF exclusivity forfeiture events.

In EU, the patent on Losartan (Cozaar) was supposed to expire in Sep, 2009. However, the Paediatric extension to the Losartan Potassium (Cozaar) at the last moment (before SPC expiry) delayed the generic launch date of various generic players to March, 2010. Earlier, in Sep, 2009 there was uncertainty on Paediatric extension status in some EU countries including UK, where patent office first rejected Paediatric extension, however, higher court granted the Paediatric extension in UK.

Now, Kluverpatentblog (http://kluwerpatentblog.com/2010/04/28/the-losartan-case-in-belgium-one-spc-too-far/) has reported interesting case of Losartan +HCTZ (Hyzaar/Cozaar Plus) launch date issues in Belgium and France. The highlights of the issues are as follows:

1) EP 0253310 (Expiry: March, 2010): the patent covers Losartan as product. The patent has got SPC in major EU countries like Belgium and France, which expired on 2 September 2009. Also, innovator Merck got Paediatric extension of 6 months for monotherpay, which expired in March, 2010.

2) EP0733336 (Expiry: February 15, 2010): This patent covers combination of Losartan and diuretic like Hydrochlorthiazide as product. The patent has got SPC in major EU countries like Belgium and France, which expired on 15 February 2010.

The various generic players were ready to launch Cozaar plus after the expiry of ‘336 patent (as no Paediatric extension was granted to this patent). However, innovator Merck opposed generic version based on the argument that paediatric extension granted to ‘310 would also covers combination of Losartan with diuretic, so generic players can not launch generic version till March, 2010.

The President of the Brussels Commercial Court on February 12, 2010 sided with generic players and opined that paediatric extension will not be applicable to Cozaar Plus. Also, Brussels Court of Appeal on February 23, 2010 upheld the commercial court’s decision.

Conversely, in France, the court opined that Paediatric extension granted to Cozaar will also cover Cozaar plus.

Overall, the patent disputes, exclusivity disputes and Paediatric extension disputes on this molecule have provided clarity to various generic players for the future generic launches in EU and US. Also, the techno-legal discussions and facts on various issues will serve as a training material for IP professionals.

Pantoprazole Sodium (Protonix) patent issues: Jury decision favorable to innovator; final decision pending

The generic player Teva (announced in a press release here ) about ongoing patent litigation and jury’s decision on Pantoprazole Sodium (Protonix) formulation.

The Jury appointed by US district Court for the district of New Jersey has opined on April 23, 2010 that innovator Nycomed’s ( who licensed the molecule’s patents to wyeth, now part of Pfizer) compound patent US4758579 (Expiry: Jan 19, 2011), which covers Pantoprazole as product is valid and infringed by generic players. Now, the court's final verdict is keenly awaited by pharma experts.

As per Teva’s press release, the Court has reserved decision on the issue of what, if any, effect to give to the jury's determinations in connection with the obviousness-type double patenting defenses, which Teva has argued is to be decided by the Court. A decision by the District Court judge independent of today's jury verdict would be sufficient to invalidate the patent.

As per USFDA database, 3 generic players have final approval for this formulation:

1) Teva: ANDA approved on Aug 2, 2007

2) Sun Pharma: ANDA approved on Sep 10, 2007

3) Kudco Ireland: ANDA approved on Mar 17, 2009

Background of the case

The generic players Teva filed ANDA on this product in April, 2004, the other generic players like Sun filed ANDA with invalidation grounds against product patent in March 1, 2005 and June 25, 2005, respectively. Subsequently, innovator applied for preliminary injunction to stop generic players from marketing generic version in New Jersey District Court. As per preliminary injunction opinion of the district court, court opined that patent is vunerable to invalidation based on strong prior art documents produced by generic players.

Generic player Teva launched Pantoprazole in 2007 and Sun launched in 2008. Further, to affect sale of generic players, innovator launched authorized generic version through Prasco in 2007.

Also, innovator appealed against district court's decision in U.S. Court of Appeals for the Federal Circuit (CAFC). During appeal, the U.S. Court of Appeals for the Federal Circuit (CAFC) unanimously affirmed the ruling by US district Court for the district of New Jersey

The district court and CAFC denied innovator Altana preliminary injunction based on strong invalidity argument in the light of following prior art:

1) US4255431: product patent on Omeprazole which discloses various structural features for optimal Proton pump inhibitory (PPI) activity

2) US4555518 : Disclosed 18 Proton Pump Inhibitors (PPI) compounds and compund number 12 exhibit structural similarity with Pantoprazole. Further, compound 12 differ from pantoprazole in terms of difference in substituents at 3 position of pyridine ring. Pantoprazole has methoxy group while compound 12 of ‘518 patent contains methyl group.

3) Article by Sachs, Brysnon and ‘431 patent on PPI which shows various structural features for optimal PPI activity like Benzimidazole ring, pyridine ring, methyl sulfinyl groups. Also, these articles describe that methoxy group at pyridine ring lowers Pka value (to about 4) of PPI and exhibit optimal PPI activity.Based on above elements district court opined the vulnerability of ‘579 on obviousness standards and denied preliminary injunction. Subsequently, Altana appealed in CAFC based on following points:

1. District court’s failure to take into account an accused infringer’s clear and convincing burden to prove invalidity

2. District Court’s selection of compound 12 (US4555518) as lead compound

3. District court’s interpretation of Sachs (George Sachs, Pump Blockers and Ulcer disease, 310 New Eng J. Med. 785 (1984), which discloses that substitution of methyl substituent with methoxy substituent in pyridine ring enhances proton pump inhibitory actions.

3. District court’s interpretation of Brysnon articles (Dr A Bryson, The ionization constants of 3-substituted pyridines, substituted quinolines and 4-substituted isoquinolines J. Am. Chem. Soc. 82, 4871 (1960), which discloses the effect of various substituents at 3 position of pyridine ring.

Further, the CAFC upheld (in May, 2009) District court’s decision and opined that elements considered by lower court while denying preliminary injunction were correct.

During ongoing full trial in New Jersey District Court, the jury found patent valid and infringed. Importantly, court’s final decision is pending which will provide more clarity w.r.t techno-legal arguments held during trial.

Sumatriptan and Naproxen (Treximet) 85 mg+500 mg Tablets: Innovator Pozen and generic player Teva settled patent litigation

Innovator Pozen (announced in a press release here) and generic player Teva settled patent litigation w.r.t generic version of the migraine treatment Sumatriptan and Naproxen (Treximet) 85 mg+500 mg Tablets.

Innovator Pozen has strong patent portfolio on this formulation. The listed patent has claims on method of use, formulation and pharmacokinetic properties of the combination

Both parties were in litigation at U.S. District Court for the Eastern District of Texas w.r.t following patents:

US6,060,499 (Expiry: Aug 14, 2017) : Which covers a method for treating a migraine patient by administering a 5-HT agonist, the improvement which comprises: concomitantly administering to said patient a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) in an amount that, together with said 5-HT agonist, is effective to reduce migraine relapse or produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence

US6,586,458 (Expiry: Aug 14, 2017): Which covers a method of treating a patient for migraine headache, comprising: (a) administering a 5-HT agonist to said patient, wherein said 5-HT agonist is a triptan; and (b) administering a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) to said patient, wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours; wherein: (i) said 5-HT agonist and said LA-NSAID are concomitantly administered in unit dosage form; and (ii) the respective amounts of said 5-HT agonist and said LA-NSAID administered to said patient are sufficient to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist.

US7,332,183 (Expiry: Aug 14, 2017): Which covers a multilayer pharmaceutical tablet comprising naproxen and a triptan and, wherein: a) substantially all of said triptan is in a first layer of said tablet and substantially all of said naproxen is in a second, separate layer; and b) said first layer and said second layer are in a side by side arrangement such that the dissolution of said naproxen occurs independently of said triptan.

Under the terms of the Settlement Agreement, litigation against Teva will be dismissed without prejudice from the consolidated litigation currently pending in the United States District Court for the Eastern District of Texas against Teva, Par Pharmaceutical, Inc., Alphapharm Pty Ltd., and Dr. Reddy's Laboratories, Inc., but will agree to be bound by the outcome of such litigation or any resulting settlements with third parties.

Repaglinide (Prandin) tablets: CAFC refused to change patent use code

In a dispute between innovator Novo Nordisc and generic player Caraco on patent Use code listed for following Orange book listed patent on antidiabetic formulation Repaglinide tablets:

US6,677,358 (Expiry: Jun 12, 2018): which covers use of Repaglinide in combination with Metformin

The CAFC has refused to correct patent use code boundary.

The dispute is due to following patent use cod listed for ‘358 patent:
1) U-968: A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
2) U-546:USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE

Innovator has earlier listed the use code U-546, which was narrow in terms of use coverage and generic player Caraco filed section viii (generic player would not market product for the patented indication) against this patent, however, innovator changed this use code to the broad U-968. The revised use code covers all approved uses of Repaglinide:
1) Use of Repaglinide as monotherapy
(2) Use of Repaglinide in combination with Metformin
(3) Use of Repaglinide in combination with thiazolidinediones

As the revised use code covers all approved uses of Prandin, USFDA refused to accept Sec viii statement of Caraco and directed them to revise the patent certification.

Caraco challenged Novo’s use code change in an FDC Act §505(j)(5)(C)(ii)(I) directing Novo to correct the listed patent information w.r.t use code, which is broad in comparison to the patent claims.

On September 24, 2009, the U.S. District Court for the Eastern District of Michigan directed innovator Novo Nordisk to change the use code from broad U-968 to narrow U-546. Court directed innovator to file the changes with USFDA with in 20 days, however, innovator appealed in CAFC, which reversed the lower court's decision. The court decided that as per FDC Act §505(j)(5)(C)(ii)(I), the innovator can correct erroneous patent listing or expiry date of the patent but not the use code.
The Judge Dyk was not in agreement with Judge Radar and Judge Clevenger and dissented against this opinion.
Related news by:

Kurt R. Kast of FDA Law Blog Here
Aaron Barkoff of Orange Book Blog here

Omeprazole + Sodium Bicarbinate (Zegerid) Capsules and oral suspension: Innovator Santarus’ key patents declared invalid by US court

In a significant decision, the U.S. District Court for the District of Delaware has declared the Orange Book listed patents of innovator Santarus (who has got licensed on the patents from University of Missouri) for Omeprazole + Sodium Bicarbinate (Zegerid) 20 mg; 1.1 g and 40 mg ;1.1 g Capsules and 20 mg/PACKET;1.68 g/PACKET and 40 mg/PACKET;1.68 g/PACKET powder for oral suspension were declared invalid due to obviousness in the light of prior publications. The following Orange Book listed patents were opposed by the generic player Par Pharma and court declared the patent invalid:

US6,489,346 (Expiry: Jul 16, 2016): Invalid due to Obviousness
US6,645,988 (Expiry: Jul 16, 2016): Invalid due to Obviousness
US 6,699,885 (Expiry: Jul 16, 2016): Invalid due to Obviousness
US6,780,882 (Expiry: Jul 16, 2016): Listed for suspension only, Invalid due to Obviousness
US7,399,772(Expiry: Jul 16, 2016): Invalid due to lack of written description as per 35 USC 112
Earlier, generic player Par filed ANDA with Para IV in 2007 for capsules and oral suspension. Subsequently, innovator sued Par for the infringement of above patents.

The patent invalidty attack of Par (in the light of well searched and debated arguments) resulted into invalidation of above key patents. Also, court found that the patent are not invalid due to inequitable conduct and refused attorney fees to Par.

As per press release by innovator (Here), Santarus is currently assessing the potential timing and impact of launch of a generic version of ZEGERID. Par has not yet received final FDA approval for any of its ANDA submissions, and Santarus is not aware of any other companies that have submitted ANDAs for generic versions of ZEGERID. As a result, the timing of a launch of a generic version of ZEGERID is uncertain.

Losartan (Cozaar) and Losartan + HCTZ (Hyzaar): Teva launched generic version

The generic player M/S Teva Pharma announced (in a press release Here ) that the U.S. Food and Drug Administration (USFDA) has granted final approval for the Company's generic versions of innovator Merck's antihypertensive Losartan (Cozaar) 25 mg, 50 mg and 100 mg tablets and Losartan + HCTZ (Hyzaar) 100+ 12.5, 50+12.5, 100 + 25 mg tablets.

Importantly, company is first to file on these products and USFDA has awarded 180-day Hatch-Waxman statutory exclusivity to market these products to Teva. Also, generic players Roxane, Torrent and Mylan have got final approval for Losartan + HCTZ (Hyzaar) 100 +12.5 mg tablets (no exclusivity on this strength).

Also, generic player Sandoz has launched authorized generic of this product.

As per USFDA database, these generic players have got final approval on Apr 6, 2010 after the expiry of compound patent US5153197, which covered Losartan as product.

Teva has got 180 days exclusivity challenge by challenging US5608075 (Expiry: Sep 4, 2009), which covers various polymorphic forms of Losartan Potassium. After Teva's ANDA filing, innovator Merck filed patent delisting request on '075 patent. However, Teva opposed this delisting and after a long legal battle with USFDA (full of twists ), Teva got exclusivity on this product. Also, generic players Roxane and Apotex challenged USFDA decision of grant of FTF 180 days exclusivity to Teva.

The brand products had combined annual sales of approximately $1.6 billion in the United States, based on IMS sales data.

For an excellent review on court cases and Teva’s dispute with USFDA, you can refer to Mr. Kurt R. Kast’ FDA Law Blog Here .

Seasonique: Teva Receives Favorable Court Decision

Innovator Teva Pharma announced (in a press release Here ) that the U.S. District Court for the District of Nevada has granted Teva's Motion for Summary Judgment with respect to the validity of U.S. Patent No. 7,320,969. In March 2008, Duramed, now Teva Women's Health, brought suit in the District of Nevada against Watson alleging infringement of Teva's patent as a result of Watson's filing of an Abbreviated New Drug Application (ANDA) for Seasonique®. The ANDA sought approval to market a generic version of Seasonique in the U.S. before the patent expires on January 30, 2024. Teva's motion sought judgment on the remaining liability issue in the case, as Watson had previously conceded infringement of Teva's patent. Since the Court granted Teva's motion in its entirety, trial is unnecessary. Separate litigation is pending in the United States District Court for the District of New Jersey with respect to Mylan/Famy Care's and Lupin's ANDAs for Seasonique. Teva is currently analyzing the impact of this decision on those cases.

Oxaliplatin (Eloxatin): Teva Settled patent Litigation with innovator Sanofi & Debipharm

Jerusalem, April 1, 2010 - Teva Pharma announced (announced in a press release Here )
today that patent infringement litigation pertaining to Teva's generic version of sanofi-aventis and Debiopharm's Oxaliplatin (Eloxatin) has been dismissed by the United States District Court for the District of New Jersey pursuant to a settlement between the parties. The settlement, which provides for a full release of Teva, includes an injunction prohibiting Teva from selling its oxaliplatin injection product and a license to reenter the market at a later point in time. Teva anticipates continued sales of its oxaliplatin injection at least through June 30, 2010, and will resume shipping additional units August 9, 2012, subject to acceleration under certain contingencies.

Gemcitabine (Gemzar®): Teva Provides Update on patent Litigation

Jerusalem, April 1, 2010 Teva Pharma announced (announced in a press release Here ) today that the U.S. District Court for the Southern District of Indiana issued a decision yesterday on two patents for Gemcitabine (Gemzar®); the compound patent expiring on November 15, 2010, and a method of use patent expiring on May 7, 2013. As to the method of use patent, the Court denied Lilly's request for an injunction on the grounds that the Eastern District of Michigan had previously found that patent invalid. Lilly has appealed that decision and oral argument is scheduled for May 7, 2010. Teva believes it is first-to-file on that patent and thus will be able to launch a generic version of Gemzar with 180-days Hatch Waxman exclusivity when the compound patent (which the Court found valid) expires or is held invalid on appeal.

Teva Provides Update on Generic Temodar®

Jerusalem, March 17, 2010 - Teva Pharma announced (in a press release Here) today that the parties to the patent litigation regarding Barr's U.S. generic version of Schering's Temodar® have entered into an agreement pending resolution of Schering's appeal to the Federal Circuit of the U.S. District Court's decision holding the '291 Patent unenforceable. Under the terms of the agreement, subject to limited exceptions, Teva will only market a generic product should the Federal Circuit uphold the District Court's decision. Furthermore, the agreement grants Teva the right to commence selling its generic product as of August 2013, during the period of Schering's pediatric exclusivity.

Teva To Acquire Ratiopharm

Jerusalem, Israel, March 18, 2010 - Teva Pharmaceutical Industries Ltd. announced (in a press release Here) that it has entered into a definitive agreement to acquire ratiopharm, Germany's second largest generics producer and the sixth largest generic drug company worldwide, for an enterprise value of 3.625 billion euro. The transaction is subject to certain conditions including relevant regulatory approvals. On a pro forma basis, the combined company would have had 2009 revenues of $16.2 billion. Teva expects to complete the transaction by year-end 2010.

(Source: Press Release of M/S Teva)