When their big brothers are enjoying the 180-day marketing exclusivities, after winning patent litigations in the US, mid-sized Indian pharma companies cannot be far behind. Indoco Remedies, a mid-sized company, is set to challenge a few of the US patents of multinational pharma companies in the near future for gaining a strong foothold in the world’s largest pharmaceuticals market.
The Rs 326-crore Indoco Remedies is planning to file 4-5 paragraph IV abbreviated new drug applications (ANDAs) within he next two years in the US market through its New Jersey-based partner, Amneal Pharmaceuticals. Para IV is a crucial part of the process of getting best returns from a drug. Out of its eight ANDA filings for patent protected drugs in the US, a few of them are leanrt to be para IV ANDAs. According to sources, Amneal would do all the legal and regulatory assistance for the para IV ANDA filings. The companies will share the cost for the filings, it is learnt. The company has a joint venture with Amneal for the regulatory and marketing affairs for its ophthalmic drugs in the US market
According to American Intellectual Property Law Association, the average cost of a patent litigation comes to around $0.5 million to $5 million for each of the firms, and in some cases, the costs could also go as high as $500 million.
What makes para IV ANDAs more attractive is the chance for gaining 180-day marketing exclusivity. Says DG Shah, secretary general, Indian Pharmaceutical Alliance, “The first-to-file is a major advantage in the US market where price erosion is very rapid. It offers reward of 180-day exclusivity. The pathway for generics is designed to incentivise early entry of generics. The risk and reward go together.”
The ANDAs are normally filed with US Food and Drug Administration (FDA), for marketing copycat versions of drugs that go off patent. On filing paragraph IV ANDA, the company which desires to launch the generic version, claims that patent of the innovator company is invalid or will not be infringed by the copycat drug, for which approval is being sought, while the certifications under paragraph I, II and III permits the ANDA to be approved immediately if it is otherwise eligible.
