Glenmark's Oxycodone HCl NDA for capsules and liquid solution under FDA review

The USFDA has completed the filing review for NDA's for oxycodone hydrochloride capsules, and liquid solution of Glenmark Generics Inc., USA. The NDA was submitted by GGI's partner Lehigh Valley Technologies (LVT). The US FDA in a letter to the company indicated that it has begun reviewing the application for oxycodone hydrochloride. Total sales for oxycodone hydrochloride capsules and liquid solution in the twelve month period ending December 2009 were USD 16 million as reported by IMS Health. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, once an NDA is accepted for filing, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA.

Synthon sued for generic tadalafil and believes to be "FTF" for 180 days exclusivity

Synthon has been sued by Eli Lilly and Icos Corporation in connection with the filing of Synthon's ANDA for Tadalafil 20 mg. Synthon's Tadalafil 20 mg Tablets product is a generic and bioequivalent version of Lilly's and United Therapeutics’ Adcirca® tablets which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. Synthon believes that it is the ’Single First Filer’ of an ANDA with a Paragraph IV certification for the Adcirca® (Tadalafil) tablets, 20 mg. As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product.

Teva Settles Generic Eloxatin Litigation

Patent infringement litigation pertaining to Teva's generic version of sanofi-aventis and Debiopharm's Eloxatin (oxaliplatin injection) 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.

Dear Friends

Dear Friends and fellow members,

After a long break of almost a month, i've come back. Sorry for the inconvenience. IPBlogger shall provide you updates time to time.

Best regards,
IPBlogger.

Ranbaxy's generic tamsulosin is delayed

Ranbaxy Laboratories’ stab at potential sales of millions of dollars has come to naught after it failed to secure the FDA’s permission to market the generic version of tamsulosin (Flomax) in the US. Ranbaxy, the Indian unit of Japanese drugmaker Daiichi Sankyo, was to launch the generic version of the Japan-based Astellas’ Flomax on March 2, 2010 in the US, eight weeks before the drug’s patent expires in the US following an out-of-court settlement in 2007. Flomax, used to treat prostrate enlargement and marketed by German drugmaker Boehringer Ingelheim, recorded sales of around $2 billion in the US last year. 

The USFDA refusal to give permission is another blow for the Gurgaon-based drugmaker, whose 30 drugs were banned by the FDA in September 2008. The FDA also halted fresh approval for two of its Indian plants for violating US manufacturing rules. Early last year, the FDA also delayed the launch of its generic version of GlaxoSmithKline’s Imitrex. The spokesman did not set a new launch date. Even if Ranbaxy is able to launch the product, its upside will be severely limited as it enjoyed only an eight-week marketing exclusivity window. 

Moreover, US-based Impax Laboratories, another generic drug maker, was able to launch its product on Tuesday.  Impax had also arrived at an out-of-court settlement with Astellas over the drug. An Impax release quoting a Wolters Kluwer Health figure said Flomax saw sales of around $1.9 billion for the 12 months ended August 31, 2009, in the US. A back-of-the-envelope calculation suggests that Ranbaxy could have earned up to $100 million during the eight-week exclusivity period. Ranbaxy would have been one of only three companies selling the drug besides Impax and Boehringer Ingelheim during that period. Once the patent of an original drug expires, several drugmakers launch their low-cost versions and there is significant price erosion, sometimes up to 95%. But during the period of marketing exclusivity, there are few players and price erosion is considerably less. 

AstraZeneca sues Lupin on Nexium IV generic

AstraZeneca sued India’s Sun Pharmaceuticals Industries Ltd. to prevent it from selling a generic form of the ulcer medicine Nexium IV in the U.S. before 2014. Sun is seeking U.S. Food and Drug Administration approval to sell Nexium in a form that is delivered through intravenous injections. AstraZeneca claims the generic copy would infringe two patents that expire in May 2014 and November 2014. Nexium IV, first approved by regulators in 2005, is similar to the “purple pill” that is most commonly sold as a capsule. Nexium in all forms generated $2.84 billion in U.S. sales last year for the London-based company, AstraZeneca said Jan. 28. Global Nexium sales were $4.96 billion, making it AstraZeneca’s biggest seller. Nexium IV is a small part of sales and is typically given while people are in the hospital through an intravenous drip, said Blair Hains, a spokesman for the company. He said the company doesn’t break out sales of Nexium IV. AstraZeneca settled patent claims against Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd., with both agreeing not to sell the Nexium pill until 2014. Similar suits are still pending against Lupin Ltd. and Dr. Reddy’s Laboratories Ltd., AstraZeneca said.

Teva Pharmaceutical Settles Lawsuit With Novartis

Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva’s U.S. generic version of Novartis’ Famvir(R) (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. Teva launched its generic famciclovir tablets in the U.S. in September 2007. The present agreement releases Teva for all past and future activities in connection with the U.S. marketing and sale of Teva’s generic famciclovir tablets. Under the terms of the agreement, Teva will make a one-time payment to Novartis in addition to an ongoing royalty on U.S. sales of the generic product.

Philippine Court denies Pfizer petition to block generic Variant

A LOCAL court has denied Pfizer Inc.'s bid to stop the sale of a generic version of anti-hypertensive drug Variant manufactured by Philippine drug-maker United Laboratories Inc. (Unilab). In a statement, Pfizer said it would ask the court to reconsider its ruling on the generic version of Atorvastatin Calcium. Pfizer and co-plaintiff Warner Lambert Co. LLC had filed a patent infringement case against Unilab in October last year. Pfizer said it owns the Philippine patent of Atorvastatin Calcium, adding this patent would expire in 2012. The drug is sold by the company under the brand name Lipitor. Unilab and its sister company Therapharma Inc. also in October last year had released Avamax, a generic version of Atorvastatin. Unilab had also filed an invalidation case against Pfizer's Atorvastatin patent before the Intellectual Property Office of the Philippines in July last year, but this case is still pending.

Teva sends ANDA certificate notification to Gilead Sciences for Viread

Gilead Sciences announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an ANDA to the USFDA requesting permission to manufacture and market a generic version of Viread^® (tenofovir disoproxil fumarate). In the notice letter, Teva alleges that three patents associated with tenofovir disoproxil – US Patent Numbers 5,922,695; 5,977,089; and 6,043,230; and one patent associated with tenofovir disoproxil fumarate – US Patent Number 5,935,946 – owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission. 

Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Viread is currently protected by four patents, which are listed in the FDA's Approved Drug Products List, and all four patents would need to be invalidated or expired before a generic version of Viread could be marketed. The USPTO confirmed the patentability of these four Viread patents in 2008.

Gilead currently has a lawsuit pending against Teva in response to Teva's attempts to seek approval for generic versions of Truvada^® (emtricitabine and tenofovir disoproxil fumarate) and Atripla^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on allegations that two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of its generic product.

Taro receives FDA Approval for Keppra® (Levetiracetam tablets)

Taro Pharmaceutical Industries Ltd. has received approval from the USFDA for its ANDA for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg. Taro's levetiracetam tablets is a prescription product used in the treatment of epilepsy, and is bioequivalent to UCB's Keppra® Tablets. According to industry sources, levetiracetam tablets had U.S. sales of over $700 million in 2009.