With the $50-billion drug market potentially up for grabs over the next five years due to a flurry of patent expirations, leading Indian drug companies are reinventing the high-risk-high-reward para-IV route. A generic company's preemptive para-IV submission allows it to challenge a patent and launch a generic version of the drug at the risk of being sued by the innovator or sell a drug that has just gone off-patent with the patent holder being the only competition.
According to sources, Indian pharmaceutical giants like Glenmark, Sun, Dr Reddy's Laboratories (DRL) and Lupin and others are primarily betting on the first-to-files (FTFs), a category of para IV which is the most lucrative one. In all, the $100-billion US branded-drug market would lose patent protection by 2018 due to a 'patent cliff' and half of this market is likely to be available for aggressive generic majors, willing to fight the patent holder in court rooms.
Para-IV filings have been a key a strategy of firms like DRL until a few years ago, but has of late lost some sheen as litigation and failure costs outweighed benefits.
The situation is now going to get better for Indian companies. For one, the impending patent cliff has increased the market potential for them manifold and secondly, the innovators have of late begun to collaborate with generic players rather than drag them to litigation.
In 2014, at least four branded drugs — Cymbalta, Nexium, Clarinex and Celebrex — with a sales potential of $12 billion will lose patent protection in the west. Companies like Sun Pharma, DRL, Lupin, Aurobindo, Alembic, Ranbaxy and others have already filed para-IV certifications to get FDA approval to sell their generic versions.
Under the US laws, an Abbreviated New Drug Application (ANDA) filed with a para-IV certification states that the generic product does not infringe on the listed patents, or that those patents are not enforceable. If the generic company is the first-to-file a para IV, it gets 'exclusive rights' to sell the generic version of a branded drug, for 180 days, with