Confirming the same, CDL Managing Director GV Prasad said that filing a law suit is a normal practice for innovators to sue applicants of generic equivalents, whenever the applicant files Abbreviated New Drug Applications (ANDA) including patent challenges. Most of Cheminor's filings in the US are patent challenges call for litigation, he added.

While AstraZeneca Inc had filed a law suit in the Federal District of New Jersey against Cheminor and Reddy-Cheminor Inc on April 20, 1999, Eli Lilly had filed the compalaint against CDL on January 11, 1999. AstraZeneca had resorted to legal action against CDL after it had submitted an ANDA for Omeprazole capsules and asserting either invalidation or non-infringement against all relevant AstraZeneca's patents.

If CDL comeover the patent litigation, it can only start sellingthe product in the US from 2001. The patent rights for Omeprazole will expire on April 5, 2001. During 1998 the US market value for Omeprazole was $2.9 billion, a 25 per cent increase over previous year.

Eli Lilly and company had also filed a complaint against CDL for submitting ANDA for Fluoxetine Hydrochloride which has a market turnover of $2.1 billion. Eli Lilly markets the formulation in the US market under the name of Prozac, he said.

Prasad said, CDL has filed, individually and together its marekting partners, about six ANDAs and propose to file nine more by the end of 1999. The generic sales of CDL will be handled by three of its marketing partners in the US. Keeping the generic market in view, the group had set up a state-of-the-art plant at Bachpally investing over Rs 50 crore. The plant complied with the USFDA norms. Though the company is ready to produce Ranitidine 75 mg it could not do so due to the extension of marketing exclusivity granted to Glaxo Wellcome for the product.

Apart fromANDAs in the US, CDL has also submitted seven dossiers for Canada, Europe, Australia and South African markets. The company has already finalised marketing arrangements for Australia and is in the process of negotiating international agreements covering the markets of South Africa, Europe and Canada.