its top slot on the ANDA table. This is because the country, credited with over 150 pharmaceutical manufacturing plants approved by the USFDA (the highest outside the US) focuses on high-volume generics and is yet to build competitive strength in the high-value specialty generics that offer attractive margins. India exported drugs worth $4 billion to the US in 2012.
There are a host of factors that augur well for Indian drugmakers in the US market. A big segment of the US branded-drugs market would be deprived of patent protection by 2018 due to a ‘patent cliff’, making available a $50-billion market for aggressive generic players.
In 2014 alone, at least four branded drugs — Cymbalta, Nexium, Clarinex and Celebrex — with a generic sales potential of billions of dollars will lose patent protection in the US.
Besides the more common generic drugs applications, US laws also allow ANDAs to be filed with a “para-IV certification” and a clutch of Indian firms is keen to seize this lucrative (yet high-risk) opportunity. A generic drugmaker making the para-IV challenge undertakes that its 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 its version of a branded drug for 180 days, with only the patent holder in the market. Dr Reddy’s Laboratories and Lupin have been the most prolific filers for para IVs, followed by Sun Pharma, Glenmark and Aurobindo.
The recent move by the USFDA to allow generic drug companies to independently update product labelling (on safety) with the requirement of just informing the brand-name manufacturer of the same is perceived to be friendly to the generic industry.
The generic drugs sector has witnessed a lot of controversy over the impending patent cliff with innovator companies angling for “pay-for-delay” deals. The patent holder would negotiate with a generic drug company to delay the entrance of the generic equivalent to the market. However, the US Supreme Court ruled that such agreements are subject to antitrust scrutiny as they prevent