Indian firms Sun Pharmaceutical Industries, Aurobindo Pharma and Glenmark Pharmaceuticals are in the catbird seat on generics of AstraZeneca's ($AZN) Crestor (rosuvastatin) after a U.S. federal judge denied a restraining order and paved the way for sales to start in the top market.
The Business Standard newspaper, citing data from IMS Health, said the drug has had annual sales of $6.8 billion in the U.S. last year, where the three firms hold U.S. FDA approvals granted on Wednesday to manufacture and market generic versions across four base categories--5 mg, 10 mg, 20 mg, and 40 mg.
The exact dates for sales to start may still face hurdles, according to the Times of India, citing an industry executive.
"In case there are fresh labelling changes as directed by the FDA, after the final hearing on the case, we will need to further plan," the executive told the Times of India.
The ruling sent shares of Sun, Aurobindo and Glenmark higher on Indian bourses Wednesday as they are seen as having an advantage in speed to the market, though other firms such as Par Pharmaceuticals, Apotex and Mylan had joined the lawsuit and are well along as well. India's Alkem Laboratories is also said to be on the path to producing a generic for the U.S. market.
The U.S. released a list of firms with approvals for rosuvastatin on Thursday. The companies named were: Mylan ($MYL), Teva Pharmaceutical, Par Pharmaceutical, Sandoz and the Indian firms Sun, Aurobindo and Glenmark.
“This is the 112th ANDA (amended New Drug Application)--including 19 tentative approvals--to be approved out of Unit III formulation facility in Hyderabad, India for manufacturing oral non-antibiotic products," Aurobindo said in a statement.
"Aurobindo now has a total of 274 ANDA approvals (234 final approvals, including 13 from Aurolife Pharma and 40 tentative approvals from U.S. FDA.”
Sun also noted the U.S. FDA approval on its website, but did not detail plans for a U.S. launch.
A Glenmark spokesman told the Business Standard that the company's current portfolio has 115 products authorized for distribution in the U.S. and 61 ANDAs pending U.S. FDA review.
AstraZeneca had argued a brand-new orphan drug approval should protect the patent until 2026 and petitioned the U.S. FDA last month to note that labels on generics would not include a new pediatric indication. But the court ruling effectively ended that appeal pathway.
- here's the story from the Business Standard