July, 2009: US pharmaceutical market is a boon for Indian pharma companies who have been successfully launching generic drugs through their subsidiaries in US on the expiry of the patented drugs by obtaining due approval from US Food and Drug Administration (USFDA). USFDA and DCGI (Drug Controller General of India) are the two important authorities for approval of the drugs before they are marketed in US and in India respectively. Many of the generic companies which want to produce the generic version of the patented drugs are required to file an application under Paragraph IV of the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act, 1984) of United States and this application is known as Abbreviated New Drug Application (ANDA). The Drug Price Competition and Patent Term Restoration Act 1984 is informally known as Hatch-Waxman Act. Once the ANDA application is approved by USFDA, the generic drug company gets 180 days of market exclusivity for selling the drug in the US market immediately after the expiry of the patent. This implies that no other generic drug company would be allowed to market the concerned generic drug during the first 180 days of market exclusivity granted to the first ANDA applicant.

Indian pharma companies have received 30 per cent of total generic medicine approved by the USFDA in the year 2008 which is higher than about 26.5 per cent share in 2007. Indian companies accounted for 35 per cent of the total ANDA approvals granted by the USFDA till February 23, 2009. Leading Indian players are Dr Reddy's, Wockhardt, Aurobindo and Sun pharma . In the year 2009 Sun Pharma received 10 ANDA approvals against 20 in the last year. Wockhardt received 18 approvals against 13 the previous year and Dr Reddy's received 5 in 2009 against 14 in the year 2008. At the same time, Ranbaxy's US drug approvals reduced from 13 in 2008 to just 3 in this year. Glenmark Generics Ltd, a US subsidiary of the Indian company Glenmark Pharmaceuticals Ltd has been granted ANDA approval by US FDA for Alclometasone Dipropionate Cream, 0.05% on 25th June, 2009 and will soon commence marketing and distribution of this product in the US market.

The price difference between the original patented drugs and the generic drugs is quite high and therefore the generic companies are able to mop up good amount of revenue in the US market by selling the generic drug at a cheaper price during the market exclusivity period of 180 days. However, the introduction of the generic drug depends upon the availability of clinical data which is restricted by virtue of the operation of data exclusivity provision in most of the advanced countries. Date exclusivity refers to protection of Clinic test data submitted by the patented drug companies to the regulating agencies for approval of their drug for marketing. Generally the term of data exclusivity protection is beyond the legal life of the patent. In United States the data exclusivity period is for 5 years and in Europe it varies from 6-10 years, in Canada, it is for 6 years and in Australia it is for 5 years. India is yet to introduce provisions for data exclusivity although there is pressure from various multinational pharmaceutical companies for introduction of data exclusivity provisions as per the controversial provisions contained in the Article 39.3 of TRIPS Agreement. India holds the view that the Indian Patent Laws are in full compliance with the TRIPS obligations.

The research team of ITAG maintains and keeps a track of the ongoing research & development in the pharmaceutical industry and provides assistance to all its clients with its database and analysis which helps them in protection of their IPR and obtaining ANDA approval from USFDA.

--Dr. D. R. Agarwal