Saturday 30 May 2009

Montelukast (Singulair) 10 mg tablets: Teva got tentative approval

Generic pharma giant Teva Pharma has got tentative approval to market Montelukast 10 mg tablets. Teva got tentative approval on May 21, 2009. Teva's generic version is bioequivalent to innovator Merck's Montelukast (Singulair) 10 mg tablets. Teva can market this product after the expiry of product patent (in 2012).
Further, innovator and Teva are in litigation on this product. Also, USPTO will re-examine innovator Merck's Orange Book listed patent. In case of favorable decision from USPTO or Court, Teva would be able to launch this product earlier in US market.

Friday 29 May 2009

Montelukast Tablets (Singulair): USPTO to re-examine key patent

The United States Patent & Trademark Office (USPTO) has accepted the request of a lawfirm (probably, representing generic player Teva) on Ex partes re-examination of blockbuster anti-allergic medication Montelukast’s (Singulair) key patent.

Innovator has listed following disputed patent in Orange Book for Montelukast’s (Singulair) 10 mg tablets and 4 mg granules:

US5565473 (Expiry: Aug 3, 2012): which covers unsaturated hydroxyalkylquinoline acids as leukotriene antagonists, including Montelukast as product.

The said patent is a blocking patent for other generic players and is a barrier to generic entry.

In March 2009, a firm that specializes in challenging the validity of patents has requested the USPTO to re-examine innovator Merck’s Orange Book listed patent US5565473 for Montelukast Tablets (Singulair).

Independent firm Article One Partners LLC announced that its online community found two pieces of evidence that suggest the asthma and allergy drug's key ingredient isn't novel. Law firm has alleged that innovator during prosecution of ‘473 patent has not disclosed some articles authored by Merck's scientist Dr. Robert Young (who proposed a receptor model on anti-allergic effects). Further, law firm alleged that the said article were very important for patentability determination of ‘473 patent.

Merck is trying to prevent Teva from making a generic version of the product before its patent expires in 2012.

Teva is first para IV filer for Montelukast tablets 4 and 5 and 10 mg/tablet. Teva filed its ANDA with para IV certification on December, 2006.


Innovator sued Teva on April, 2007 for the infringement of '473 patent. The case is ongoing at New Jersey District. If Teva succeed in its attempt, then generic space will open early for this product in US market
Update

Innovator Merck has released a press release Here , in response to USPTO's decision of patent reexamination. As per press release, innovator opined that patent reexamination is an administrative procedure by USPTO that can be initiated by any person/organisation. Importantly, if a potential new issue of patent invalidity is raised, the USPTO will examine patent claims in the light of new issues. Further, In the event that the USPTO decides further action is warranted, it may amend or revoke the claims in the patent.

According to the USPTO website, the average time it takes the USPTO to decide ex parte reexaminations is roughly 24 months. The PTO's decision can be appealed to the Court of Appeals for the Federal Circuit before it becomes final.

Tuesday 26 May 2009

Cinacalcet (Sensipar): Teva sued innovator for process patent infringement

Teva has filed patent infringement lawsuit against Innovator Company Amgen w.r.t Cinacalcet process patent infringement in Distric court for Eastern district of Pennsylvania. Generic pharma giant Teva got following process patent:

US7449603 (assignee: Teva, Date of Grant: November 11, 2008): Which covers process and intermediates for the synthesis of Cincalcet

Earlier, innovator sued Barr (Now, subsidiary of Teva) for filing Para IV on Cinacalcet (Sensipar) 30, 60 and 90 mg tablets in March, 2008 as reported by us Here . Subsequently, innovator sued Teva and Barr in Delaware district court in July, 2008.


Now, it will be interesting to monitor counter litigation strategy of Teva against innovator.

Also, Teva has asserted it’s API process patents on Carvedilol (Coreg) like US7,056,942, US6,710,184, US6,699,997, and US7,126,008 against various generic players and later on settled with some players like Ranbaxy Laboratories, Dr Reddy's Laboratories and USV Ltd , Glenmark (as reported by us on this product Here ) and recently with Cadilla . The product patent on Carvedilol has already expired but API process patents of Teva are blocking for other generic players.

Monday 25 May 2009

New Paragraph IV Patent Certifications reported by USFDA till May 19, 2009

1) Abacavir Sulfate 300 mg Tablets (Ziagen) Para IV filed on Jan 28, 2009

2) Cevimeline Hydrochloride 30 mg Capsules (Evoxac) Para IV filed on Feb 27, 2009

3) Conjugated Estrogen (Synthetic A) 0.625 mgTablets (Cenestin) Para IV filed on March 2, 2009

4) Dextromethorphan Polistirex 30 mg/5 mL Extended-release Suspension (Delsym) Para IV filed on Jan 12, 2009

5) Doxycycline 40 mg Delayed-release Capsules (Oracea) Para IV filed on Dec 11, 2008

6) Formoterol Fumarate 0.02 mg/2 mL Inhalation Solution (Perforomist) Para IV filed on Jan 21, 2009

7) Ropinirole Hydrochloride Extended-release Tablets (Requip XL)3 mg Para IV filed on Jan 8, 2009 and 12 mg on Feb 5, 2009

8) Levocetirizine Dihydrochloride 0.5 mg/mL Oral Solution (Xyzal) Para IV filed on Jan 14, 2009 (Probably, Synthon is the only ANDA filer for this product as per press release from Synthon Here )


9) Travoprost (Preserved) 0.004% Ophthalmic Solution (Travatan Z) Para IV filed on Feb 19, 2009

10) Trospium Chloride 60 mg Extended-release Capsules (Sanctura XR) Para IV filed on March 2, 2009

(Source: USFDA)

Friday 22 May 2009

Budesonide Respules (Pulmicort) inhalation suspension (0.25mg/2ml, 0.5mg /2ml): Preliminary injunction granted in favor of innovator

U.S. District Court for the District of New Jersey has granted Preliminary injunction decision in favor of innovator AstraZeneca, till decision on pending patent infringement trial (as confirmed by innovator in the press release Here ).

The said decision will block generic launch of Budesonide Respules (Pulmicort) inhalation suspension (0.25mg/2ml, 0.5mg /2ml) by Apotex. Earlier, the same court issued the temporary restraining order against generic launch.
The trial date for this case is yet to be confirmed, which is scheduled in the same court

Background of this case
Innovator AstraZeneca filed a patent infringement lawsuit in April, 2009 against Canadian Pharma giant Apotex to block a generic version of AstraZeneca 's lucrative Budesonide Respules (Pulmicort) inhalation suspension (0.25mg/2ml, 0.5mg /2ml) anti-asthma formulation.

Innovator has listed the following patents in Orange Book for this product:


US6598603 (Expiry: Jun 23, 2019): which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day.

US6899099 (Expiry: Jun 23, 2019): which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day, wherein the administration is in the evening.

US7524834 (Expiry: May 11, 2019): Which covers a pharmaceutically acceptable, micronized powder composition at least 98.5% by weight of which is pure budesonide or an ester, acetal or salt thereof, wherein the composition meets the criteria of sterility according to the US Pharmacopoeia 23/NF18, 1995, pages 1686-1690 and 1963-1975.

Innovator sued Apotex for the infringement of Orange Book listed patents in U.S. District Court for the District of New Jersey. Also, innovator requested court for preliminary injunction against generic version by Apotex.


Earlier, innovator sued Ivax (Teva) in 2005 and Breath pharma in 2008 for filing ANDA with Para IV against orange book listed patents.


Also, in November 2008 innovator settled with first para IV filer Ivax (Teva) after later launched its product ‘at risk’ in US market in Novemeber, 2008. Subsequently, Teva agreed to settle with innovator and delayed generic launch till December, 2009, however, Teva would pay royalty based on sale of this product to innovator.


As per USFDA records, two generic players Ivax (approved on November 18, 2008) and Apotex (approved on March 30, 2009) have approved ANDA for this product.


Although, Ivax (Teva) is first Para IV filer for this product, however, due to failure to market drug product with in stipulated time of final approval from USFDA (as per Medicare Modernization act provisions on generic exclusivity), Teva has forfeited its 180 days generic exclusivity.

Apotex was ready to launch this product “at risk” to became the first generic player to capture lucrative generic market on this product.

Budesonide inhalation suspension (0.25mg/2ml, 0.5mg /2ml, 1mg /2ml) was approved by USFDA on Aug 8, 2000.

IP Pharma doc’s detailed analysis on this product Here

Wednesday 20 May 2009

Cefdinir (Omnicef) 300 mg capsules: Court of Appeal for Federal Circuit’s opinion in favor of generic players

Court of Appeal for Federal Circuit (CAFC) in a hearing en banc decision has upheld district court’s earlier decisions on motion for grant of summary Judgment of non-infringement (on appeal from Lupin) and refusal of preliminary injunction against various generic players w.r.t litigation on Cefdinir (Omnicef) 300 mg capsules, between innovator Abbott and Astellas against generic player Sandoz, Ranbaxy, Par and Lupin.

The following patent was at issue in Cefdinir litigation:

US4935507 (Assignee: Fujisawa Pharma, Date of Grant: June 19, 1990, Expiry: Dec 4, 2011):

The said patent has following independent claims:

1. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem.-4-ca rboxylic acid (syn isomer) which shows the peaks at the diffraction angles about 14.7 about 17.8 about 21.5 about 22.0 about 23.4 about 24.5 about 28.1 in its powder X-ray diffraction pattern.

2. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-car boxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-car boxylic acid (syn isomer) at room temperature or under warming.

5. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-car boxylic acid (syn isomer) which is obtainable by dissolving 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-car boxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.

Further, innovator’s patent ‘507 claims priority from Japanese patent application JP62-206199 (‘199 patent). The ‘199 patent disclosed crystalline form B (Cefdinir monohydrate) and crystalline form A (Cefdinir anhydrate), however, innovator claimed ‘507 patent broadly than ‘199 patent and used words like 'crystalline' to cover all crystalline forms in product-by-process claims 2-5 .


Generic players developed their non-infringing formulation using crystalline form B (Cefdinir monohydrate). Innovator Abbot’s marketed formulation contains crystalline form A (Cefdinir anhydrate). Also, generic players successfully designed around against the process limitation of product-by-process claims 2 to 5.


After filing ANDA on Cefdinir (Omnicef) 300 mg capsules, innovator sued various generic players. The district court construed the claims in the light of specification and prosecution history and other extrinsic evidences. Further, claim construction by district court suggested that ‘507 patent covers only form A.

The district court concluded that innovator’s ‘507 patent do not cover Form B (which innovator intentionally missed in ‘507 patent, although, priority patent application JP‘199 has disclosed both forms), accordingly, there is no infringement either literally or under the doctorine of equivalence.

The District Courts of Eastern Virginia granted summary Judgment of non-infringement motion by Lupin and District Courts of Illinois refused preliminary injunction against various generic players.

In the May 18, 2009 decision, the CAFC upheld the claim contruction and various elements decided by district courts in this decision. Also, court opined that infringement of a product-by-process claim (claim 2 and 5) requires practicing the claimed process step limitation in the accused product. Importantly, generic players are not using process element of claim 2 and 5 in the generic Cefdinir product, accordingly, there is no infringement.


Cefdinir is chemically 8-[2-(2-amino-1,3-thiazol-4-yl)-1-hydroxy-2-nitroso-ethenyl]amino-4-ethenyl-7-oxo-2-thia-6-azabicyclo[4.2.0]oct-4-ene-5-carboxylic acid and is a broad spectrum semisynthetic antibiotic. Innovator got approval from USFDA to market this drug on Dec 4, 1997


Opinion of the court Here

Tuesday 19 May 2009

Sevelamer Carbonate (Renvela) 800 mg tablets: Innovator sued Lupin

Innovator Genzyme had sued Indian generic players Lupin for allegedly filing ANDA with Paragraph IV certification as part of Lupin's generic version of Genzyme's Sevelamer Carbonate (Renvela) 800 mg tablets.

Following patents are listed in Orange Book for this product:


US5496545 (Expiry: Aug 11, 2013): The patent covers formulation and method of use


US5667775 (Expiry: Sep 16, 2014) : The patent covers a method for removing phosphate from a patient by ion exchange comprising orally administering to said patient a therapeutically effective amount of a composition comprising Sevelamer

US6509013 (Expiry: Aug 11, 2013): The patent covers a pharmaceutical composition consisting essentially of a carrier and at least one water insoluble, crosslinked polymer

US7014846 (Expiry: Aug 11, 2013) : The patent covers a pharmaceutical composition comprising a carrier and a crosslinked, water insoluble polyallylamine homopolymer, wherein said polyallylamine homopolymer comprises repeat units wherein said polyallylamine homopolymer is crosslinked with an epichlorohydrin crosslinking agent, and wherein the homopolymer is fully protonated, partially protonated or unprotonated.


US6858203 (Expiry: Aug 11, 2013): The patent covers method for removing phosphate from a patient comprising orally administering to said patient a therapeutically effective amount of a composition comprising at least one polymer characterized by a repeat unit (in a markush structure) and or a copolymer thereof, wherein each n is an integer, each R, independently, is H or a lower alkyl, alkylamino, or aryl group, and each X.sup.- is a carbonate or bicarbonate anion


US7459151 (Expiry: Aug 11, 2013): The patent covers a method for removing phosphate from a patient in need thereof comprising orally administering to said patient a therapeutically effective amount of a pharmaceutical composition comprising a crosslinked, water insoluble polyallylamine copolymer wherein said crosslinked, water insoluble polyallylamine copolymer consists of a crosslinking agent

Innovator Genzyme has sued Lupin for the infringement of '545, '775, '013, ‘203 and '846 patents in District Court of Maryland.

Earlier, Lupin sent its Para IV letter to innovator, accordingly, innovator sued lupin within 45 days to delay Lupin's ANDA approval for 30 months.


This formulation is protected by new salt exclusivity, which will expire on Oct 19, 2010.


Earlier, innovator sued Lupin for filing para IV on Renagel (Sevelamer hydrochloride) as reported by us Here.


Also, innovator has sued Impax for this product as reported by us earlier.


Sevelamer was first disclosed in USSR patent 417441 (patent by Tashkent Polytechnic University), accordingly, there is no product patent for this compound. Further, to thwart generic challenge innovator has listed patents covering method of use and formulation in Orange Book.


About Renvela
Genzyme had sales last year of $678 million for Renagel and a companion drug, Renvela, the company said last month. Renegal is used for the control of serum phosphorus in patients with chronic renal failure and on dialysis. Genzyme reported $4.6 billion in total revenue for 2008.
About Lupin
Lupin is an aggressive Indian generic player and in recent times have many First To File Para IV filings and other Para IV challenges to its credit. Recently, Lupin settled patent litigation on Venlafaxine extended release (Effexor) capsules as reported in their press release Here

Monday 18 May 2009

Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300 mg) (Atripla):Innovator Files Second Patent Infringement Lawsuit

Refer to our earlier news on Atripla Here , wherein, we reported Para IV filing by Teva pharma on Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg (Atripla). After receipt of Para IV notice letter, innovator Gilead Sciences announced (in a press release Here ) that it has filed a lawsuit in U.S. District Court in New York against Teva Pharma for infringement of following Orange Book listed patents for Atripla [(Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg]:
US6642245 (Expiry: May 4, 2021): which covers a method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): which covers a (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer

Teva has challenged above patents by sending Para IV letter to innovator, wherein , Teva alleged that patents on Emtricitabine are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission:
Earlier, Teva challenged the validity of ‘245 and ‘396 Emtricitabine patents with an ANDA filing for Truvada® (Emtricitabine and Tenofovir disoproxil fumarate)The antiviral combination is currently sold in the United States through a joint venture between Bristol-Myers Squibb (BMS) and Gilead.

Pantoprazole Sodium Delayed Release (DR) Tablets: The CAFC upheld District court’s decision

The U.S. Court of Appeals for the Federal Circuit (CAFC) unanimously affirmed a September 2007 ruling by US district Court for the district of New Jersey, which denied a motion filed by innovator Wyeth and Altana for a preliminary injunction related to generic launch of Pantoprazole Sodium Delayed Release (DR) Tablets by generic players like Teva, Sun pharma and Schwarz paharma.

Earlier, district court denied Altana preliminary injunction based on strong invalidity argument developed by generic companies w.r.t Altana’s Orange Book listed product patent US4758449 (Expiry: Jul, 2010). The generic companies alleged that innovator’s patent on Pantoprazole which is chemically 6-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-1H-benzo[d]imidazole is obvious in the light of following strong prior art:

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

2) US4555518: disclosed 18 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 ‘449 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, Brysnon articles

Further, The CAFC upheld District court’s decision and opined that elements considered by lower court while denying preliminary injunction were correct.

Opinion of court Here

Thursday 14 May 2009

Risedronate Sodium Tablets (Actonel) 5mg, 30mg and 35 mg: Procter & Gamble Wins Patent Infringement Lawsuit; Generic version blocked till 2014

Innovator Procter & Gamble (P&G) announced (in a press release Here ) that United States Court of Appeals for the Federal Circuit (CAFC) has ruled in favor of P&G in the patent infringement lawsuit filed by P&G against Teva . The positive ruling protects P&G's rights in the U.S. to exclusively market the osteoporosis therapy Actonel(R) (risedronate sodium) tablets. Actonel is commercialized through collaboration between Procter & Gamble Pharmaceuticals and Sanofi-Aventis.
Following patents are listed in orange book w.r.t Risedronate tablets 5 mg, 30 mg and 35 mg:

US5583122 (Expiry: Jun 10, 2014)- Which covers Risedronate Sodium as product

US6096342 (Expiry: May 22, 2012)- Which covers a pharmaceutical composition comprising, from 0.15% to 40.00% by weight of a risedronate active ingredient and from 60.00% to 99.75% by weight of excipients comprising: lactose monohydrate, microcrystalline cellulose, crospovidone, and magnesium stearate

US6165513 (Expiry: Dec 10, 2018)- Which covers an oral dosage form comprising a safe and effective amount of a bisphosphonate wherein said oral dosage form is oval shaped, about 0.23 to about 0.85 inches in length, about 0.11 to about 0.4 inches in width, and about 0.075 to about 0.3 inches in thickness and said oral dosage form is film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus wherein said film coating allows for delivery of said bisphosphonate to the stomach


On August 13, 2004 P&G filed a patent infringement lawsuit against generic giant Teva to block generic version after Teva submitted ANDA with Para IV certification against Orange Book listed patents. Further, innovator alleged infringement of ‘122 patent against Teva. On February 28, 2008, the United States District Court of Delaware ruled in favor of P&G, expressly rejecting Teva's validity challenge. Subsequently, Teva filed an appeal of the decision. Oral arguments for the appeal were heard in December 2008.


Teva was seeking to market a generic version of Actonel in the United States under the assertion that the product patent ‘122 was not valid due to obviousness of the invention in the light of prior art disclosure in US4761406 (a prior patent by P&G on bisphosphonate).

The ‘406 patent disclosed (1-hydroxy-1-phosphono-2-pyridin-2-yl-ethyl)phosphonic acid compound (2-Pyrd-EHDP), however, Risedronate is chemically (1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid (3-Pyrd EHDP). The CAFC observed that patent is not obvious in the light of prior art disclosure.

Also, court observed a person having ordinary skill in the art at that time would not have selected 2-pyrd EHDP as lead compound for further structural modification to arrive at 2-pyrd EHDP (Risedronate). Also, court gave weightage to testimony by P&G expert and articles of Dr. Fleisch (Who had some published work to his credit on bisphosponate chemistry at that time). Dr. Fleisch wrote in 1984 that “every compound, while remaining a bisphosphonate, exhibit it’s own physical-chemical, biological and therapeutic characteristics, so that each Bisphosphonate to be considered of it’s own. To infer from one compound the effect in another is dangerous and misleading” Based on this published work, court rejected Teva’s structural similarity argument between 2-Pyrd EHDP and 3-Pyrd EHDP compounds. Additionally, court rejected obviousness type double patenting argument of Teva as claims of ‘406 patent and ‘122 were not same.


Teva has approved ANDA for Residronate tablets. As a result of CAFC's decision, Teva can market its generic version of Procter & Gamble's Risedronate Sodium Tablets, 5mg, 30mg and 35 mg after the expiry of ‘122 patent in June, 2014.


The U.S. Food and Drug Administration approved Actonel in 2000 for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures with in a year


CAFC opinion Here

Earlier news of IPPharma Doc on this product Here

Wednesday 13 May 2009

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Pantoprazole 20mg and 40mg tablets: Actavis launched generic version after key patent expiry in Germany, Ireland, Netherlands

Actavis launched Pantoprazole tablets in Germany, Ireland, and the Netherlands (as reported by Actavis Here) after the key patent EP166287 expired on 6 May (SPC expiry). This is Actavis Group’s first own brand launch of this molecule.
In Germany and the Netherlands, the product was also launched by Actavis’ third party sales division’s (Medis’) customers at the same time. Earlier this year, Medis’ customers launched the product in Hungary and Poland.IMS Health reported EU Brand sales of EUR1.1 bln in 2008.

Friday 8 May 2009

Mycophenolate Moefetil (Cellcept) 250 mg capsules and 500 mg tablets: generic players enter into the market after product patent expiry

The various generic players has got approval to market Mycophenolate Moefetil (Cellcept) 250 mg capsules and 500 mg tablets after Mycophenolate's product patent US4753935 expired on May 3, 2009.

Following generic players have got final approval to market this drug from USFDA:


1. SANDOZ
2. ROXANE
3. ACCORD HEALTHCARE
4. ZYDUS PHARMS
5. TEVA PHARMS
6. MYLAN
7. APOTEX

Earlier, innovator ROCHE PALO got approval to market Mycophenolate Moefetil tablets on June 19, 1997 and Mycophenolate Moefetil capsules on May 3, 1995.

As per IMS health, U.S. sales of Mycophenolate Moefetil are approximately $680 million for tablets and $367 million for capsules, respectively, for the 12 months ending March 31, 2009.

Mycophenolate is used for the prevention of organ transplant rejection and acts as an immunosuppressant.

Earlier news of IP Pharm Doc on this product Here

Wednesday 6 May 2009

Pregabalin (Lyrica) 25, 50, 75, 100, 150, 200, 225, 300 mg/capsule: Innovator Pfizer sues generic player

Pharma giant Pfizer has filed patent infringement suit against various generic players, who have filed ANDA with Para IV certification against Orange Book listed patents for neuropathic pain treatment Pregabalin (Lyrica) 25, 50, 75, 100, 150, 200, 225, 300 mg/capsule.

The lawsuit was filed on April 29, 2009 in Delaware District Court

Please read full article on following link:

http://genericpatentology.blogspot.com/2009/05/pregabalin-s-3-aminomethyl-5.html

Monday 4 May 2009

Doxycycline Hyclate (Doryx) 150 mg DR tablets: Innovator sued Mylan

Innovator Warner Chilcott and it’s subsidry Mayne announced (in a press release Here )
that they have filed a second lawsuit against generic player Mylan in the District Court for the District of New Jersey for patent infringement of Orange book listed patent US6958161 (Expiry: Dec 15, 2022) for submission of an Abbreviated New Drug Application to the USFDA with Paragraph IV certification to sell a generic version of Doxycycline Hyclate (Doryx) 150 mg DR tablets.
Earlier news of IPPharmdoc on this product Here

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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