News: India top drug tweaker again

(DNA 16/08/2006) Mumbai - The $8-billion Indian pharmaceuticals market, which is growing at a rate of 9%, has been on the top in the filings of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) in the US market. They have lived up to this reputation in the second quarter of 2006 as well. According to a Morgan Stanley study, Indian companies account for the largest share of 35% in the overall 355 DMFs filings.

A DMF is a submission to the US Food and Drug Administration that may be used to provide confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of one or more human drugs.

Out of the 32 Indian companies which submitted 97 drug dossiers, mid-sized companies appear to have taken the lead in terms of the number of DMFs filed. Aurobindo topped the list with 21 filings, followed by Lupin and Matrix with 9 and 8 filings, respectively. Among larger companies, Sun Pharma filed 6, Dr Reddy’s Lab (3 including one from the Mexican facility) and Ranbaxy 1.

Some of the Indian companies filed DMF submissions for 180-day exclusivity include Dr Reddy’s (Benicar -$640 million brand), Matrix (Emtriva-$20 million, Abilify-$1.7 billion), Dabur (Eloxatin- $1.2 billion), and Sun Pharma (Gleevec-$670 billion). Interestingly, the companies filed early DMFs for the products, which the innovators launched only 2-3 years ago.

Roughly 25% of the DMFs submitted in 2006 targeted matured generics and the rest targeted new patent expiries over the next few years. The number of filings per product is also rising. Six new filings for desloratadine (Clarinex), indicating the continuing competitive landscape and high pricing pressure, were made in the quarter.

Aurobindo filed for cefepime and cefdinir whereas Orchid Chemicals filed for cefdinir. The patents of both Omnicef ($650 million brand, cefdinir) and Maxipime ($150-million, cefepime) will be expired in 2007. Aurobindo also filed for piperacillin, one of the active ingredients for Zosyn, which will also be expired in 2007. A few DMF submissions were done by Matrix and Aurobindo for anti-AIDS drugs.