Indian firms queue up for $20-bn US drug generics

:

n about two months from now, one of the largest selling drugs in the world Zocor (Simvastatin) will go off-patent, allowing companies to sell generic copies of the $4-billion Merck-owned cholesterol-lowering drug.
 
This is just one of the $20 billion worth of drugs that are slated to go off-patent over the next 20 months, and Indian companies are aggressively filing for permissions to sell the bulk drug (API or active pharmaceutical ingredient) as well as the final formulation in the US through a conscious strategy of “vertical integration”.
 
According to the latest report of Banc of America Securities (a Bank of America subsidiary), seven of the top 10 DMF filers at the US FDA are Indian. DMFs or Drug Master Files are required to get permission to sell bulk drugs in the US (see Chart)
 
Indian companies also account for 21 per cent of the ANDA’s filed. ANDA or Abbreviated New Drug Applications are filed to get permission to market the final formulations, which typically offer higher margins than bulk drugs.
 
This number stands out when compared with ANDA filings from Europe at 1 per cent while the balance 78 per cent is from the US itself.