Pharma cos got 32% of total US FDA generic drug approvals

UR Associates has come out with its report on pharma sector. According to the research firm Indian pharma companies received 32% of total US FDA generic drug approvals during the April-June period.

The US FDA has in total given 151 generic product approvals and tentative approvals (excluding labeling revisions, modified indications and manufacturing changes) during the period April-June 21st. An analysis of the US FDA generic drug approvals during this period reveals some interesting facts:

• Canadian based Apotex Pharma with 16 approvals is the company with the highest number of ANDA approvals during the period
• Teva Pharmaceuticals with 10 product approvals is the second highest during the period
• Indian pharma companies including its foreign subsidiaries have received 49 ANDA approvals. This is equivalent to 32% of the total approvals
• Sun Pharma and Aurobindo Pharma with seven approvals are the Indian drug companies that received the highest number of approvals during the period. These companies are closely followed by Dr. Reddy’s (6 approvals), Strides Arcolab (5 approvals), Torrent Pharma (4 approvals), Hetero Labs (4 approvals), Glenmark (3 approvals), Cipla (3 approvals), Lupin, Alembic Pharma and Orchid Healthcare (2 approvals) and Ranbaxy, Suven Lifesciences, Wockhardt and Jubilant Organosys (1 approval)
• Some of the major drugs that became generic during the period and the Indian drug companies that received approval are: 
• Plavix (market size of USD6.7 bn) - Sun Pharma, Aurobindo Pharma, Dr. Reddy's, Torrent
• Zyprexa (market size of USD3.3 bn) Dr. Reddy’s, Sun Pharma, Torrent Pharma, Aurobindo Pharma and Orchid Healthcare
• Valtrex (market size of USD1.3 bn)- Jubilant Organosys
• Boniva (market size of USD510 mn) - Dr. Reddy's

Boehringer Ingelheim in talks for OTC brand buyouts: According to senior officials of the company, Boehringer Ingelheim GmbH (BI) the $ 17 billion German drug maker is scouting for acquiring major OTC brands, and has already started early stages of discussions with Indian drug makers. According to industry estimates, the OTC drug market in India is worth $1.5-2 billion and is growing at 15-16% per annum. “We are evaluating various options, including brand buyouts, to establish a strong presence in the OTC space. We are in discussions with a few companies,” said Sharad Tyagi, managing director of Boehringer Ingelheim India. “We have not fixed any target, but looking at what are available in the market. We are interested in areas of consumer health care and pain management. Tyagi made it clear that BI is never interested in company buyouts in India. “BI does not believe in buying growth by buying turnover, which is evident from the fact that there have been no large, expensive acquisitions.”

Merck in talks to buy Micro Labs: Merck has begun talks with the Suranas, the promoters of the unlisted Micro Labs, to purchase the company, a person with direct knowledge of the development said. “Micro Labs and Merck have shared information,” the person said. Companies share information when they are willing to negotiate a future deal and are followed later by due diligence. “As a policy we do not comment on rumors or speculations,” a Merck (named MSD in India) spokesperson said in an email response. Micro Labs, founded in 1973 by GC Surana, a pharmaceutical dealer, has a strong presence in active pharmaceutical ingredients (APIs) and finished formulations with a marketing and distribution network in both India and overseas.

U.S. District Court rules against Natco Pharma in Copaxane patent infringement case: The U.S. District Court for the Southern District of New York has ruled in favor of Teva in the Company's patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding Teva's relapsing-remitting multiple sclerosis (RRMS) product, Copaxane. The judge rejected Momenta/Sandoz and Mylan/Natco's claims that the patents are invalid and unenforceable and found that the purported generic versions of Copaxane infringe those patents. This ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of Copaxane in the U.S. until the Orange Book patents expire on May 24, 2014.