Lupin to sell generic Glumetza in US market, with 6-month sole seller status

Lupin’s U.S. subsidiary, Lupin Pharmaceuticals Inc., has got approval to sell the generic form of an anti-diabetes drug (for type II diabetes) in the U.S. market. Currently, specialty biopharmaceutical company Santarus Inc. holds the right to market the patented drug Glumetza HCL ER in the U.S. market, the generic form of which (Metformin Hydrochloride extended release tablet) Lupin will market in dosages of 500 mg and 1000 mg. The patented form of these dosages had recorded sales worth $144 million (equivalent to approx. Rs 858 crore) in the U.S. in the 12 months ending March 2013, Lupin added.

Lupin said it believes it is the first company to file an ANDA (Abbreviated New Drug Application) for Glumetza HCL ER Tablets for 500 mg and 1000 mg strengths. If that is indeed the case, it will get an exclusive right to sell the drug for 180 days (around 6 months) in the U.S. market.

The patent for Glumetza HCL ER is held by Depomed and U.S. marketing rights are held by Santarus. Santarus and Depomed in February 2012 agreed to permit Lupin to begin selling the generic version of Glumetza on February 1, 2016 or earlier under certain circumstances. Apart from Lupin, Sun Pharmaceutical Industries and Watson Laboratories are also involved in patent challenging litigations with Santarus and Depomed. View more details on this in the 10Q filing of Santorus, by clicking here.

Lupin made the announcement yesterday 5 minutes before the stock market closed for the day. Its share price was up around 1 per cent or 8.70 rupees at 899.20 at 10.45 am today.

To view the press release issued by Lupin on the launch, click here.

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