Filing DMF is necessary for third party sale of pharma ingredients in the US, which is similar to abbreviated new drug applications (ANDAs) for formulations.
In 2012, drugs worth $35 billion went off patent in the US while the market size of drugs, which will see patent expiry in 2013, comes down below half to $17 billion.
In the quarter ended December 2012, there has been a total of 143 DMFs filed with the US FDA and the share of Indian companies (70 DMFs) stands at 49% of the total. The share of DMFs from India touched a high of 51% in 2009, up from 36% in 2005.
According to a report by Kotak Institutional Equities Research, the share of Indian companies filing DMFs has stabilized around 50% over the past four years.
"Most of the filings from Indian companies are targeted at recent or upcoming New Chemical Entity (NCE)-1 opportunities. The NCE-1 landscape is expected to remain competitive based on multiple DMFs," said the Kotak report. DMF for NCE-1 can be filed at the end of fourth year from date of approval for NCE. Exclusivity for NCE is given for five years.
Among the Indian firms which have filed DMFs in the last quarter, Biocon leads the race with filing DMF for Rosuvastatin, generic version of Crestor, one of the largest selling anti-cholesterol drug with annual sales of $3 billion.
Another major Dr Reddy's is vying for the pie of Fingolimod, generic of Gilenya, a multiple sclerosis drug with $750 million sales.
There have been additional filers for upcoming NCE-1 opportunities— Alembic (Febuxostat-$150 million), Cadila (Lacosamide-$300 mn), Glenmark (Lacosamide, Rufinamide), Lupin (Fesoterodine-$100 mn), Ranbaxy (Lacosamide), Sun Pharma (Fesoterodine, Febuxostat-$150 mn) and Wockhardt (Fesoterodine).
Dr Reddy's is top of the table among DMF filers in 2012 with 13 filings followed by Lupin (12), Cadila (11) and Sun Pharma (11). Among the mid-sized players, Hetero Drugs is at the top with 38 DMFs, followed by 15 by MSN Laboratories in 2012.
