The NYSE-listed drugmaker received an abbreviated new drug application approval from the U.S. Food and Drug Administration for EluRyng, the first generic version of Merck & Co.’s NuvaRing, according to a media statement.
The New Jersey-based company said it initiated commercialisation activities for the drug, which is being manufactured internally and launching on Dec. 12. Shares of Amneal Pharma surged 33 percent, the most in five months, on the New York Stock Exchange after the announcement.
NuvaRing’s annual sales in the U.S. stood at nearly $976 million for the 12 months ended Oct. 31, according to IQVIA, a healthcare data and analytics provider. The drug at present doesn’t have any approved generic in the U.S. Teva Pharmaceutical Industries Ltd., Mayne Pharma Group Ltd. and Dr. Reddy’s are other drugmakers that have applied to the U.S. FDA to make the copycat version for the American market.
In August, Dr. Reddy’s said it received a complete response letter from the U.S. health regulator for its generic version of NuvaRing and was preparing for a response. Initially, the Indian company had scheduled to launch the drug in the first six months of calendar year 2019 but that, according to the company after the second-quarter earnings, got delayed by 10-12 months because of the U.S. FDA letter. Erez Israeli, chief executive officer of Dr. Reddy’s, had said during the post-earnings conference call that he expected the drug to be launched in the financial year ending March 2021.
Dr. Reddy’s has yet to respond to BloombergQuint’s emailed queries.
Acknowledging the risk of a competitor launching the drug first, Girish Bakhru, pharma analyst at Bank of America Merrill Lynch, estimated NuvaRing to generate sales worth $50 million in FY21 and FY22 each for Dr. Reddy’s.
SBICAP Securities, in its latest report, said the drug is estimated to contribute $100 million to the company’s top line through FY23.
Prashant Nair, pharma analyst at Citi Research, said a launch before mid-2020 was unlikely and any further delay couldn’t be ruled out. Nair expects Dr. Reddy’s to launch the generic in the second half of the next calendar year as opposed to the first quarter forecast earlier.
Dr. Reddy’s other competitor Mayne Pharma, in a post-earnings conference call, said its approval was delayed. Teva said it expected an approval later this year.