Lupin seeks US FDA approval for generic Glumetza; Depomed may sue for patent violation

Depomed may take lagal route to protect the patent rights of it extended release antidiabetic pill Glumetza even as Lupin seeks regulatory approval to market a generic version of the the drug in US.

Lupin Ltd, India’s fifth largest generic maker, has filed an abbreviated new drug application (ANDA) for a generic version of Depomed’s patented drug Glumetza with US FDA.

Glumetza contains the anti-diabetic drug metformin hydrochloride. Depomed sells Glumetza extended release tablets in 500 mg and 1000 mg strengths.

Lupin Ltd has issued a Paragraph IV certification notice to Depomed, Inc regarding filing of an ANDA with the US FDA for a generic version of Glumetza (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths.

Commercial rights of Glumetza is protected under various patents in US.

Glumetza’s US Patent No. 6,340,475 is set to expire in 2016, US Patent No. 6,488,962 will expire in 2020, US Patent No. 6,635,280 will expire in 2016 and US Patent No. 6,723,340 will expire in 2021.

Lupin’s certification notice said that Depomed’s US Patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange Book for Glumetza are invalid and/or will not be infringed by Lupin’s commercial manufacture, use or sale of the products described in Lupin’s ANDA.

Depomed is currently evaluating the Paragraph IV certification filed by Lupin with US FDA, the company said in an official release.

Depomed “continues to have full confidence in the intellectual property protecting Glumetza” the statement said.

On receiving the para IV certification notice, Depomed now has 45 days  to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, US FDA from approving Lupin’s ANDA for 30 months or until a district court decision that is adverse to the company, whichever is earlier.

Glumetza (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. promoted by Santarus, Inc promotes Glumetza in the United States.

Swedish drug maker AstraZeneca has filed a lawsuit against India’s generic firm Lupin for allegedly violating its valid patents on its gastric reflux disease drug Nexium (esomeprazole magnesium delayed release capsules) though seeking to sell a generic version in US.

Meanwhile, AstraZeneca has started legal proceedings against Lupin by filing a lawsuit in the district court of New Jersey alleging that Lupin’s abbreviated new drug application (ANDA) has infringed its United States Patent Nos. 5,714,504 (’504), 5,877,192 (’192),
6,875,872 (’872), 6,369,085 (’085), and 7,411,070 (’070).

AstraZeneca has settled a similar patent litigation on Nexium with Ranbaxy Laboratories in the District Court of New Jersey, in April, 2008, allowing Ranbaxy to start marketing generic version of Nexium on May 27, 2014 and can formulate and supply the key ingredient of the product even by May 2010 to AstraZeneca.

Lupin has also settled several patent infrigment lawsuit including that of Effexor XR, desloratadine and ramipril with brand name companies after challenging them as a startegy in previous years.

Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline.

Depomed’s candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Solvay Pharmaceuticals.

A New Drug Applications for DM-1796 is expected to be filed with the FDA in the first quarter of 2010. Product candidate Serada is in Phase 3 clinical development for menopausal hot flashes.

Depomed  formulates its products and product candidates with its proprietary Acuform drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy.