Market Overview – ANDA submissions

In the year 2009, a record breaking number of ANDA’s were filed by the by the world’s leading generic drug players. In the year 2009, 100 ANDA’s were filed by the top 10 companies. The top 10 companies account for more than 50% of the total filed ANDA’s. Some of the top Indian companies which have driven the growth of the ANDA market are Wockhardt, Glenmark, Dr. Reddy, Aurobindo and Ranbaxy to name a few. The Indian Pharmaceutical Industry accounts for nearly 32% of the total filed ANDA’s in the year 2009.

Based on these statistics, it can be definitely predicted that growth of the Indian Pharmaceutical companies is likely to achieve its desired milestones. This can only happen f the regulatory laws continue to support the submission rates. The Healthcare reimbursement policies highlighted by the US government clearly favour the use of generic drugs. However, the nature by which the Indian Pharmaceutical companies tackle the “Pay for Delay” / patent litigations, will decide the future of the ANDA submissions.

2009 has been a record low year for new drug applications by the USFDA. Only 27 applications have reached the final stages. It can be clearly seen that safety profiles of newer drugs (i.e. the adverse event profile of the drugs has made companies withdraw their pipelines) are major hurdle in the New Chemical entity market. Existing drugs are now being tested for newer indications. These are also some of the factors which will add to the growth of the generic drug market in the USA.

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