Friday 27 June 2008

Pramipexole Product patent got invalidated in district court of Delaware for double patenting

Barr Pharma announced that U.S. District Court for Delaware has invalidated the Orange Book listed product patent of innovator Boehringer Ingelheim's Mirapex Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.
Following patents are listed in Orange Book for Pramipexole Dihydrochloride Tablets
US4886812 (Expiry: MAR 25,2011)- Product patent (specific)
US6001861 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
US6194445 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
Barr successfully invalidated US4886812 (product patent) protecting Mirapex in the District Court in Delaware. In a significant ruling, District Court Judge opined that the product claim in litigation are invalid because of double patenting.
Earlier, Barr received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the USFDA, Barr notified Boehringer Ingelheim, the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.
Also, in Feb 2008, Barr got final approval on its ANDA but decided to launch the product until the earliest of the following occurs: 90 days following the conclusion of the presentation of evidence in the District Court trial, the date a favorable judgment for Barr is entered by the District Court, or July 14, 2008.
Now Barr with First Para IV filing exclusivity can immediately launch its product in US market and other generics can also enter by the end of this year or in the first half of 2009 i.e after the expiry of 180 days FTF exclusivity of Barr.

Pramipexole was approved by USFDA on July 1, 1997. Barr has got final approval on February 19, 2008 and Mylan has got Tentative approval on May 8, 2007. Earlier, innovator has also sued Mylan for '812 parent

IP pharma Doc has earlier reported about trial on this case here

Atorvastatin (Lipitor): Pfizer patent held invalid by South Korean court

In a significant decision South Korean District court thwart patent evergreening attempt of Pfizer on Atorvastatin (Lipitor) in South Korea and held the patent invalid. The decision favored 5 generic companies, who were eagerly waiting for this decision.
Earlier, Korean Intellectual Property Tribunal (KIPT) in July 2007, ruled in favour of the local companies, which include Dong-A Pharma and Boryung Pharma . Although the original patent for the drug expired in May 2007, Pfizer extended it to 2013 by modifying the patent.
Now companies can sell Atorvastatin without any risk.
Further, Pfizer has announced that it will appeal against this decision in Supreme court

Thursday 26 June 2008

Valganciclovir Hydrochloride (Valcyte) Analysis: Ranbaxy got tentative approval

Ranbaxy Labs got the tentative approval from the USFDA to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Ranbaxy is First Para IV filer generic company and is entitled for 180 days exclusivity. Ranbaxy and innovator Roche are in litigation on US6083953 (Expiry: Mar 29, 2015) which covers 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinate hydrochloride (Valganciclovir) in crystalline form as product.

Ranbaxy has designed around the '953 patent by preparing their formulation by amorphous form of Valganciclovir (as patent covers crystalline form). Roche in its complaint has alleged that on stability Ranbaxy product will convert to crystalline form.

Innovator Roche got approval on this product on Mar 29, 2001 for the treatment of Cytomegalovirus and is mainly used for eye infection, on absorption this drug is converted into the body into Ganciclovir by esterase enzymes present in intestine and liver.

Drug approvals/Launch: Teva: Ramipril, Cipla: Lamivudine/Stavudine

Teva: Ramipril
Teva has launched Ramipril Capsules, which are available in 2.5 mg, 5 mg, and 10 mg strengths, in bottle sizes of 100.

Taro: Cetirizine Hydrochloride Syrup
Taro Pharma got final approval from the USFDA for its ANDA for Cetirizine Hydrochloride Syrup, 1 mg / 1 mL

Cipla: Lamivudine/Stavudine
FDA granted tentative approval to Cipla on fixed dose combination Lamivudine/Stavudine tablets, 30mg/6mg & 60mg/12mg for oral suspension for pediatric. The application was reviewed under President's Emergency Plan for AIDS Relief (PEPFAR)

Thursday 19 June 2008

Atorvastatin settlement: A setback for generic players

As speculated by IP Pharma Doc that Pfizer is interested in rest of the shares of Ranabaxy to keep off generic challenge on Atorvastatin and on similar line Ranbaxy settled with innovator Pfizer on Lipitor and Caudet on June 18, 2008. Pharma giant Pfizer and Ranbaxy agreed to keep generic version of the cholesterol lowering drug Atorvastatin off the U.S. market with an extra 20 months exclusivity for Pfizer, a move that may generate billion dollars for the pfizer. Ranbaxy would have enter into the market on March 25, 2010, when the main patent ('893)expires, while Pfizer was using litigation either on Orange book patents or process patents covering amorphous form of Atorvastatin to delay generic competition until 2016. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and Caudet (Atorvastatin-Amlodipine Besylate) in the United States effective Nov. 30, 2011. Ranbaxy will also have a license to sell Atorvastatin in other countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam. The Atorvastatin patents involved in this agreement are following orange book listed patents:

US4681893 (Expiry: 24 March, 2010)- Covers racemic form of Atorvastatin generically.
Litigation update: Ranbaxy was unsuccessful in invalidating the said patent in US Court of Appeals For Federal Circuit (CAFC) in 2006. Futrther, during recent reexamination of ‘893 by USPTO on request from a Lawfirm representing Ranbaxy, the USPTO as per their May 2008 decision upheld the validity of ‘893 patent. Teva and cobalt has filed Para III against this patent

US5273995 (Expiry: 28th June, 2011) -Covers Atorvastatin enatiomer as Product (Specific)
Litigation update:

1. The patent was invalidated by CAFC in August 2006
2. Pfizer applied for reissue of the patent to USPTO, which was rejected twice by USPTO. On April 2008, USPTO again rejected Pfizer request
3. In Caudet litigation Pfizer stated that it has issued convenant not to sue (will not sue Ranbaxy for the infringement of said patent) to Ranbaxy, in case ‘995 patent is reissued to Pfizer
4. Innovator Pfizer sued Cobalt and Teva for the infringement of ‘995 patent
5. On 15 May 2008, Court entered Judgment in favor of Pfizer and delayed Cobalt ANDA approval till expiry of ‘995 patent

US5686104 (Expiry: 11th May, 2015) Covers Formulation

Litigation update: Pfizer has sued cobalt but not asserted patent during trial
US5969156 (Expiry:8th June, 2017) Polymorph (Form I, II and IV)
Litigation update: Pfizer has sued cobalt but not asserted patent during trial

US6126971 (Expiry: 19th July, 2013) Covers Formulation
Litigation update: Pfizer has sued cobalt but not asserted patent during trial

US6455574 (Expiry: 11 August, 2018): Covers Formulation (Combination of Atorvastatin Form I and Amlodipine Besylate)

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

Summary of patent litigation settlement
Ranbaxy would have entered the market on 25 March, 2010 with its own generic version of Lipitor as Pfizer has issued convenant not to sue to Ranbaxy on ‘995 patent, but it choose to settled with innovator.The said settlement has delayed Ranbaxy’s entry into the generic market till 30 November, 2011. Now other generic player can market their product after the expiry of Ranabxy’s First to File 180 day’s exclusivity, which will expire on 1 June, 2012. The deal is a setback for other generic players who were expecting their product launch by September 26, 2010. Now the US Federal Trade Commission (FTC) will review the deal. There is a possibility that generic players like Cobalt and Teva would oppose the deal and FTC can consider the public harm by 20 months delayed availability of generic Lipitor to patients

Further, there are many stories after the settlement that what Ranbaxy gained from the settlement? Although some experts have speculated that possibally Ranbaxy would launch its product with crystalline form of Atorvastatin. Ranbaxy has filed its ANDA with amorphous form 27 of Atorvastatin (there are 2 amorphous forms of Atorvastatin form 23 which Pfizer earlier used for development and even conducted clinical trials and Form 27 which is more compact and most generic players have developed their formulation using Form 27). As per citizen petition submitted by Pfizer in 20o5, Pfizer showed that amorphous form degrade quickly in comparison to crystalline and requested USFDA to not approve any amorphous formulation of Atorvastatin.
Link to New york times article on settlement details.

Also, Mint has reported on this settlement here

Tuesday 17 June 2008

Abraxis to Appeal Jury Ruling on Abraxane Patent Infringement Claim

Abraxis BioScience announced that it will appeal the jury ruling in the U.S. District of Delaware that Abraxis has infringed upon a patent owned by Elan. In the suit, Elan claimed that Abraxis infringed upon Elan's patent 5399363. The jury ruled that Abraxis has infringed upon Elan's ‘363 patent, which will expire in 2011, and awarded Elan $55 million in damages for sales of Abraxane(R). The company announced it is disappointed by the jury ruling in this complex patent litigation and feels confident as it proceeds to appeal in this matter. Abraxis will pursue post-trial motions and appeal the judgment of the District Court.

Drug approvals: venlafaxine (Mylan), Irbesartan and Hydrochlorothiazide (Mylan), Escitalopram (Lupin)

Mylan got Final Approval for Venlafaxine Hydrochloride, Irbesartan and Hydrochlorothiazide
Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the USFDA for its ANDA for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

Mylan got tentative Approval for Avalide (Irbesartan and Hydrochlorothiazide )Tablets
Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the USFDA for its ANDA for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg


Lupin Receives USFDA Approval for Escitalopram Oxalate Tablets
Lupin announced that it has received tentative approval for the company's Abbreviated ANDA for Escitalopram Oxalate Tablets 10 mg and 20 mg from the USFDA

Monday 16 June 2008

Now Pfizer interested in Ranbaxy

As speculated earlier by IP pharma doc that behind Ranbaxy sell out Lipitor may be the one of the reason, now forbes has came out with an article ( Link to forbes news) that Pfizer is interested in remaining shares of Ranbaxy. The purpose of this interset is due to billion dollar revenue generator "Atorvastatin" (Lipitor and caudet) First to file exclusivity. After the expiry of Pfizer's patent on Atorvastatin in March 2010, Ranbaxy can severely dent the sale of Lipitor and Caudet and to stop generic competition for 6 months will result in huge financial benefit to pfizer.

Saturday 14 June 2008

Elan wins $55.2m damages over breach of cancer drug patent

Elan won $55.2m in damages when a federal jury decided rival, Abraxis BioScience infringed a patent for medicine used to fight breast cancer, contending Abraxis' intravenous paclitaxel drug Abraxane for the treatment of metastatic breast cancer uses technology protected by Elan's 1995 patent for tiny anti-cancer nanoparticles.Paclitaxel is a mitotic inhibitor used in cancer chemotherapy. It was discovered in a National Cancer Institute program at the Research Triangle Institute in 1967 when Monroe E. Wall and Mansukh C. Wani isolated it from the bark of the Pacific yew tree, Taxus brevifolia and named it 'taxol'. When Bristol-Myers Squibb (BMS) licensed the compound for sale they claimed rights to the name as well and people responded by referring to the generic name as 'paclitaxel', but BMS later lost the court case about naming rights. In this formulation paclitaxel is dissolved in Cremophor EL, a polyoxyethylated castor oil, as a delivery agent since paclitaxel is not soluble in water. A newer formulation, in which paclitaxel is bound to albumin as the delivery agent (Protein-bound paclitaxel), is sold commercially by Abraxis BioScience under the trademark Abraxane
Link to news

Cabilly patent :Genentech settled its patent dipute with MedImmune

Genentech announced that it has settled its patent litigation dipute with MedImmune involving the Cabilly patent US6331415, which covers A process for producing an immunoglobulin molecule or an immunologically functional immunoglobulin fragment comprising at least the variable domains of the immunoglobulin heavy and light chains, in a single host cell, comprising the steps of: (i) transforming said single host cell with a first DNA sequence encoding at least the variable domain of the immunoglobulin heavy chain and a second DNA sequence encoding at least the variable domain of the immunoglobulin light chain, and (ii) independently expressing said first DNA sequence and said second DNA sequence so that said immunoglobulin heavy and light chains are produced as separate molecules in said transformed single host cell.

Under the terms of the settlement agreement, the litigation, which was pending in the U.S. District Court of California, has now been fully resolved and dismissed. The settlement resolves disputed issues with respect to MedImmune's marketed product Synagis(R) (palivizumab) as well as a related product (motavizumab) for which MedImmune is seeking regulatory approval. The settlement also permits MedImmune to obtain licenses for certain additional pipeline products under the Cabilly patent family. MedImmune filed its original complaint in April 2003. Following a U.S. Supreme Court decision in January 2007, the case was returned to the lower courts for further proceedings. Financial terms of the settlement were not disclosed. In connection with this settlement and the associated licenses, Genentech is not updating its forecasted royalty revenue.

Drug approvals: Teva got tentative approval for Valsartan tablets; Lupion launched Ramipril

Teva got tentative approval to market Valsartan Tablets
Teva Pharma announced that the USFDA has granted tentative approval for the Company's ANDA to market its generic version of Novartis' hypertension treatment Diovan(R) (Valsartan) Tablets, 40 mg, 80 mg, 160 mg and 320 mg. Final approval of this product is expected upon expiry of patent protection for the brand product in September 2012, as well as any periods of marketing exclusivity that may be awarded. The brand product had U.S. sales of approximately $1.5 billion for the twelve months ended March 30, 2008, according to IMS data.

Lupin launched Ramipril Capsule
Lupin Pharmaceuticals, Inc. announced today that the USFDA has granted final approval for the Company's ANDA for Ramipril capsules, 1.25 mg. 2.5 mg, 5 mg and 10 mg. Commercial shipments of the product have commenced. Lupin earlier was successful in invalidating product patent of innovator and subsequently USFDA gave 180 days exclusivity to Cobalt (first Para IV filer).

Thursday 12 June 2008

News Analysis: Ranbaxy goes to Japanese hands

Japan’s third-largest drugmaker will get a 50.1 percent stake in India’s largest pharmaceutical company in a bid to diversify as government price cuts shrink margins and generics outpace brand-name meds.
The move mimics Novartis, which operates the Sandoz unit that swallowed up two generic drugmakers in 2005 to reduce reliance on brand-name drugs. “Daiichi Sankyo’s strategy follows Novartis and it’s convincing,” Fumiyoshi Sakai, a health-care analyst at Credit Suisse Securities, tells Bloomberg News . “The essence of the deal is Daiichi Sankyo will seriously challenge generic business.”
Price cuts in Japan mean that Daiichi Sankyo’s profit is likely to fall 18 percent this year as its main blood pressure treatments lose sales. Meanwhile, local rivals - Takeda Pharmaceutical, Astellas Pharma and Eisai - have spent more than $14 billion on acquisitions since November 2007 to buffer sales declines as their best-selling drugs lose patent protection, Bloomberg reminds us.
“The proposed transaction is in line with our goal to be a global pharma innovator and provides the opportunity to complement our strong presence in innovation with a new, strong presence in the fast growing business of non-proprietary pharmaceuticals” Takashi Shoda, Daiichi’s CEO, says in a statement . In particular, the deal gives Daiichi greater reach into India, China and Eastern Europe.
The Japanese pharmaceutical market will grow 1 percent to 2 percent this year, according to IMS Health, while India’s pharmaceutical market may expand by more than 12 percent a year, reaching $20 billion by 2015, McKinsey said in a report in August, Bloomberg notes.
“This signals that there is a lot of value in the Indian pharmaceutical industry, Jayesh Shroff of SBI Asset Management in Mumbai, tells Bloomberg. “The drugmakers have underperformed in the past three years. It’s also a good signal for the overall market with about $4 billion in foreign direct investment coming in.”
The acquisition will help Japan to increase the volume of generics as a part of a governments plan to trim health care spending. Japan wants generics to account for 30 percent of prescriptions by 2012 from 17 percent, according to Bloomberg. (The above news was published in Pharmalot)
IPPharmadoc analysis of News: The deals many experts say is good for Ranbaxy as it got more than its value in the market. But a careful examination of the deal shows that Singh brothers (Malvinder and Shavinder) have anticipated future losses and the various litigations on Atorvaststin, Nexium, Valaciclovir and other products proved quite expensive for the company. Ranbaxy in recent times have settled their patent disputes with innovators on products like Nexium and Valacyclovir. Although Ranbaxy has First To file exclusivity on some products in US but their launch is possible only by end of 2009. Further, a cut of share in domestic market and adverse patenting outcomes led Singh Brothers to strike the deal.
The deal was on cards after the USPTO reexamination of '893 product patent of Atorvastatin(the decision was against Ranbaxy) and Ranbaxy could market generic form of Lipitor and Caudet only in March 2010. As the reports shows taht singh brothers were in negotiation with GSK, Daiichi and Novartis since the the last 4 months
But overall the deal is good for Daiichi whose innovative products were getting off-patent and their revenue was decreasing. A strong generic company like Rabaxy with excellent infrastructure and proven R&D capabilities will add color to Daiichi's Generic business.

Wednesday 11 June 2008

Famciclovir product patent invalidated: CAFC upheld district court decision

The US Court of Appeals for Federal circuit (CAFC) has affirmed the district court judgment in an appeal filed by Novartis against Teva w.r.t Famciclovir. The court has invalidated the Famciclovir product patent US5246937 . The district court ( decision ) eralier held the patent obvious based on prior art compound Penciclovir. Famciclovir is a prodrug of Penciclovir. For the said case court considered KSR V/s Teleflex and Takeda V/s Alpharma (pioglitazone) case while considering selection of compounds and obviousness crieteria Novartis has filed an appeal in United States court of Appeals for Federal Circuit on September 6, 2007 after getting denied preliminary injunction by The United States District Court for The District of New Jersey. Following patents are listed in orange book for this product
US5246937 (Expiry: Sep 21, 2010)- which covers purine derivatives like Famciclovir as product
US5840763 (Expiry: Sep 1, 2015)- Method of use for herpes viral infection
US5866581 (Expiry: Oct 4, 2014)- Method of use for post-herpetic neuralgia
US5916893 (Expiry: Sep 1, 2015)- Method of use for latent infection of herpesviruses
US6124304 (Expiry: Oct 4, 2014)- method of use for the treatment of zoster associated pain
Teva has approved ANDA for 125 mg, 250 mg and 500 mg tablets, the ANDA was approved on August 24, 2007. Innovator has also sued Roxane pharma who has filed Para III against the product patent '937 and Para IV against rest of the patents in March 2008.

Omeprazole Formulation patent: Court of Appeal for federal circuit affirmed non-infringement of Mylan formulation

Mylan Inc. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a May 2007 District Court ruling stating that Mylan's 10 mg and 20 mg Omeprazole delayed-release capsules do not infringe patents asserted against Mylan by AstraZeneca. Omeprazole is the generic version of AstraZeneca LP's Prilosec(R).

Mylan and others challenged Astrazeneca’s patents on grounds that their generic formulations do not infringe two Astra’s listed patents. TheDistrict of New York court agreed that the generic formulation do not infringe. On appeal was the question of whether the generic versions contained an “alkaline reacting compound” (ARC) as required by the claims.
Astra argued that the talc used by the generic products included an ARC. The CAFC agreed that the lower court had properly rejected that argument based in part on language in the specification. Specifically, the nearly identical specifications listed several different ARCs but did not include talc on the list. “In contrast, the specifications also lists a number of ordinary excipients, among which one of them is talc. The specifications themselves indicate that ARCs do not include talc.”
Mylan launched its Omeprazole products on August 4, 2003, despite the patent infringement litigation, which at the time was unprecedented in the generic pharmaceutical industry.

Monday 9 June 2008

Aripiprazole: Innovator Otsuka Pharma sued Zydus Pharma

Innovator Otsuka Pharma has sued Zydus Pharma for the Infringement of US5006528 (Orange Book expiry: 20 April, 2015: which covers novel carbostyril derivatives like Aripiprazole as product specifically) in the District Court of New Jersey following a paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (For the treatment of bipolar disorder and schizophrenia) in 2, 5, 10, 15, 20, and 30 mg/Tablet. Following generic players are in litigation with innovator :
1.Sandoz
2. Teva
3. Barr
4. Apotex
5. Synthon
6. Sun
The first para IV filing against this product was on November 15, 2006. There are no approved/tentatively approved ANDA for this product.

Saturday 7 June 2008

Keppra (Levetiracetam): Innovator UCB got Pediatric Exclusivity in USA

UCB announced that the USFDA has granted pediatric exclusivity for Keppra(R) (Levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001. The Keppra(R) US '639 patent was set to expire in July 2008, however, this grant extends the period of exclusivity on Keppra(R) across all licensed indications by six months to January 2009. Only one patent is listed in Orange Book for this product
In October 2007, UCB announced that it had reached an agreement to settle pending patent infringement lawsuits in the US. Under the terms of the settlement agreement with Mylan, and subject to its receiving FDA approval, Mylan will be allowed to sell its generic levetiracetam tablets effective November 1, 2008, in advance of the expiry of UCB's market exclusivity on January 14, 2009.
Levetiracetam is an anticonvulsant medication used to treat epilepsy. It is S- enantiomer of Etiracetam, structurally similar to the prototypical nootropic drug Piracetam. Along with other anticonvulsants like Gabapentin, it is also sometimes used to treat neuropathic pain.

Zaleplon Capsules: Roxane and Teva announced the approval of their ANDA

Roxane and Teva announced the approval of their ANDA for Zaleplon Capsules CIV, 5mg and 10mg. The product is available in bottles of 100 capsules for immediate shipment to wholesalers and pharmacies nationwide
Zaleplon (N-[3-(7-cyano-1,5,9-triazabicyclo[4.3.0]nona- 2,4,6,8-tetraen-2-yl)phenyl]-N-ethyl-acetamide: marketed under the brand names Sonata and Starnoc) is a sedative/hypnotic, mainly used for insomnia. It is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class.

Depakote: Mylan entered into a settlement and license agreement with Abbott

Mylan has entered into a settlement and license agreement with Abbott Laboratories relating to a generic version of Abbott's anti-seizure drug Depakote ER.
According to a filing with the Securities and Exchange Commission, Mylan Pharmaceuticals has been granted a 180-day exclusivity period to sell 500 mg Divalproex extended-release tablets upon their launch, which will occur no later than Jan. 1, 2009. The agreement also provides a license for the 250 mg tablets to be launched no later than Jan. 1, 2009. Subsequently, all litigation between Mylan and Abbott relating to Divalproex ER will be dismissed, the filing said. Abbott first filed a patent infringement suit against Mylan relating to its Depakote Extended-Release drug in November 2005. The formulation patents for the drug expire in 2018, the company said. Depakote, including the extended-release version, had U.S. sales of $1.48 billion in 2007. divalproex sodium consists of a compound of sodium valproate and valproic acid in a 1:1 molar relationship in an enteric coated form. It is used in the UK and U.S. for the treatment of the manic episodes of bipolar disorder, and increasingly taken long-term for prevention of both manic and depressive phases of bipolar disorder, especially the rapid-cycling variant. It is also used in the US for the treatment of epilepsy, chronic pain associated with neuropathy, and migraine headaches. Its chemical name is sodium hydrogen bis(2-propylpentanoate).

Thursday 5 June 2008

Azor (Olmesartan Medoxomil+ Amlodipine Besylate): Daiichi sue Matrix (first para IV filer) for patent infringement

Japanese pharma giant Daiichi Sankyo has sued Matrix (Mylan) for patent infringement on blood pressure drug Azor.
Azor is the brand name of an oral antihypertensive medication which combines two antihypertensive agents in a film-coated tablet. It contains Amlodipine Besylate, a calcium channel blocker, and Olmesartan Medoxomil, an angiotensin-2 receptor antagonist (ARB or A2A). The patent is held by Daiichi Sankyo Pharmaceuticals. It is promoted in the U.S. by both Daiichi Sankyo and Forest Pharmaceuticals.Azor is available in different dose preparations: 5mg/20mg, 10mg/20mg,5mg/40mg and 10/40mg's of amlodipine and olmesartan respectively.
Mylan said Daiichi Sankyo filed the suit in a New Jersey federal court Tuesday against its India-based unit Matrix Laboratories Ltd., citing Matrix's application earlier this year with the Food and Drug Administration to sell a generic version of Azor. Following patent is listed for Azor in Orange Book
US5616599 (Expiry: Apr 25, 2016): The patent covers Olmesartan Medoxomil as product
Matrix is the first company to file an application with a Paragraph IV certification. Azor, which was approved on Sep 26, 2007, had sales of $22 million for its fiscal 2007 ended March 31, 2008. Azor has got new combination exclusivity, which will expire, on Sep 26, 2010.
Mylan is already in litigation on the same patent (‘599) for Benicar®(Olmesartan) and Benicar HCT®(Olmesartan/hctz) tablets in New Jersey District Court. Mylan is First para IV filer for Benicar and Benicar HCT.
Mylan has won FTF exclusivity for 3 products ( Olmesartan tablets, Olmesartan/hctz tablets and Olmesartan/Amlodipine tablets) by preparing invalidation ground against Olmesartan product patent

Wednesday 4 June 2008

Regulatory/IP update

*Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules USP in the 8mEq and 10mEq strengths.

*Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet

*Lannett Company to Launch Amantadine Hydrochloride Soft Gel Capsules, 100 mg

*Watson Receives Final Approval of Omeprazole Delayed-Release Capsules 10mg, 20mg and 40mg

*U.S. Patent & Trademark Office (PTO) has completed the second of four reexamination proceedings and has confirmed the patentability of US5922695 which covers the composition of matter for Viread (Tenofovir Disoproxil Fumarate).

*Barr has filed Paragraph IV on Entocort Enteric Coated Capsules (Budesonide), 3mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort

Fentanyl buccal tablet: Cephalon Files Patent Infringement Lawsuit Against Watson

Cephalon today announced that it has filed a lawsuit in U.S. District Court of Delaware against Watson for infringement of US6200604 (Expiry: Mar 26, 2019) and US6974590 (Expiry: Mar 26, 2019), which cover methods of use for the O.B listed product Fentora (Fentanyl buccal tablet).
Fentanyl (N-(1-(2-phenylethyl)-4-piperidinyl)-N-phenyl-propanamide) was approved by the USFDA in September 2006 for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. One advantage of such tablets is claimed to be quicker absorption into the bloodstream at lower dosage levels.Fentanyl is not considered a first line opioid in palliative care.

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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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