14 of 90 first-time generic drug approvals from FDA go to Indian firms


India Receiving Higher Percentage of FDA Generic Approvals

India is one of the world’s fastest growing economies and that increasing economic strength is now being felt in the generic pharmaceuticals industry as Indian companies look to expand beyond domestic consumer bases.

The US market for generic drugs remains strong. Generics make up 88% of all prescriptions filled in the US, and according to statistics in the Office for Generic Drugs (OGD) Annual Report, released earlier this month, 2015 saw the Food and Drugs Administration (FDA) issue a record 726 approvals and tentative approvals for generic drugs. December 2015 alone saw the highest number of approvals in a single month since the generic drug program began.

The report also revealed that as the market for generic drugs continues to thrive, Indian companies are having a growing influence at the cutting edge. Of the 90 first-time generic drug approvals granted by the FDA in 2015, 14 were issued to Indian pharmaceuticals companies.

Among the many Indian firms to appear in the report were Sun Pharma, whose Imatinib Mesylate tablets are used to treat cancer; Glenmark, who received approval for a copy of the fat-lowering drug Zetia; and Lupin, whose Repaglinde and Metformin Hydrochloride tablets were also cleared in 2015.

This increase of Indian involvement in the US generics market is part of a wider trend of growth in the country’s pharmaceuticals industry, which has also seen many Indian companies do deals with major Western-based multinationals.

India Still Facing Regulatory Action From FDA

The news isn’t all good for the Indian generics industry. Several major Indian companies, including Sun Pharma, Dr Reddy’s Labs and Cadila, have faced regulatory action from the FDA, mainly relating to industrial facilities that don’t reach established international standards, and of the 11 Indian companies inspected since January 2016, seven have been ordered to improve.

But such additional scrutiny is in itself a sign of the growing influence of the country’s generics manufacturers, and despite the short-term regulatory challenges, it seems likely that Indian generics companies are likely to be increasingly significant players in the US generics market in the months and years ahead.






Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.com

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