The number of approved abbreviated new drug applications (ANDAs) filed by Indian pharmaceutical companies?which have aggressively launched copycat versions of off-patent drugs in the US market?has declined dramatically in the last four months.
Generic companies file ANDAs to obtain marketing approvals for drugs whose patents expire in the United States, the world?s largest pharma market. Last year, Indian firms accounted for a quarter of all ANDA filings submitted with the US Food & Drug Administration (US FDA).
However, according to FDA figures, the number of tentative or final ANDA approvals given to Indian players in September this year was 18, or 7.3% of the 239 total approvals. This was down from 25 approvals out 200 in August (12.5%), and 20 out of 150 (13%) in July. In June, Indian companies received 29 approvals out of 196 (15%).
Analysts attributed this to a conscious decision by Indian companies to reduce the number of applications filed with the FDA. ?Sometimes, companies are not keen to file ANDAs for generic drugs having a lower market potential,? said an analyst on condition of anonymity. ?If the number of ANDA approvals declines on a year-on-year basis, it is something to be viewed with concern,? said another.
Interestingly, Indian companies compete amongst themselves in the US for the largest selling drugs. For instance, out of the 16 ANDAs approved last month for the generic version of the $1.7-billion cardiac drug Coreg (carvedilol), eight were bagged by Indian firms.