A generic manufacturer spends virtually nothing on R&D, does not mean that without effort generics can be marketed. It actually requires the demonstration of safety and effect of the product by the innovator to the regulator for approval. The factors such as patent expirations on drugs, cost cutting measures on healthcare by US governments and the rising aging population in advanced countries and also the internal factors in India such as cost advantages in research, development and manufacture of drugs, well experience in reverse engineering of drugs, experience gained in the launch of generic products in less regulated markets and higher investment capital play major role in the sustained growth of the Indian generic players. Authorized generics, shared exclusivity, OTCs, more approval on day one and the larger size of the market are some attractive features of the US market, which makes every Indian generic company to be aggressive to step in the US market despite heavy launching expenses and stiff opposition from the competitors as well as the inventors. The generic market in US is also characterized by substantial price competition and well-established and often regulated pricing and reimbursement schemes. India tops with the highest number of Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDAs) in the USA. ANDA approvals for generic formulations and DMF listings for APIs are a prerequisite for any pharma company looking to enter the US generic markets.
Ranbaxy has filed total 14 patents in USA and taken up research programmes in the segments of infectious diseases, urology, metabolic diseases and inflammatory/respiratory diseases. Dr Reddy’s Laboratories filed 9 DMFs during 2004-05. Its 65 DMFs and 45 ANDAs are awaiting approval from US FDA. Cipla Ltd, the second largest Indian pharma company with net sales of Rs 2,242 crore, has strong presence in generic segment in USA. It has entered tie-up for more than 120 products and focusing more on filing of DMFs and ANDAs in USA. Glenmark has filed 6 ANDAs and 13 DMFs during 2004-05 and it is planning to submit 14 additional ANDAs in the current year. Orchid Chemicals and Pharmaceuticals has filed first ANDA for cefazolin in April 2004. So far, it filed 18 ANDAs and 16 DMFs. Cadila is set to enter the US generic market in the current year and filed 12 ANDAs and 16 DMFs during 2004-05. Cadila has 15 US patents to its credit. Zydus Cadila ended 2003-2004 with 12 ANDA filings, the largest number of ANDA filings by an Indian pharma company in the first year of applications for filing. Aurobindo pharma has filed 31 DMFs till June 2006 and Sun pharma has filed 11 DMFs. The aforementioned facts regarding the DMFs and ANDAs filed reveal that the tough competition among the Indian players after 2000, which necessitates every player to invest heavily in capital investment over the last few years independent of size. In 2004-2005, the total amount of filing reached to 313 DMFs, which is about 33% of the total filings. This competitiveness could be clearly visible in the number of DMFs filed within the 6 months of 2006 accounting for about 175.
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