Can Indian pharma fully exploit the patent cliff?

Branded drugmakers may suffer from patent losses on their biggest drugs, but that suffering spells opportunity for generics makers. Some $100 billion worth of branded meds come off patent over the next two years, giving copycat drugs the chance to capture huge parts of the drug market that previously were out of bounds.

But as Reuters reports, this enormous opportunity is not without its pitfalls. Competition among generics firms is already heating up, and so is litigation over the rights to sell particular knockoff meds. Meanwhile, the FDA has stepped up its oversight, as several generics makers have discovered the hard way.

Nowhere is the battle over generics more heated than in India, which has a strong presence in copycat drugs, but also has its share of troubles. Morgan Stanley analysts say Indian firms could add $2 billion to $2.5 billion to their U.S. sales over the next five years--provided all goes well.

And that's the question, at least for some companies. Ranbaxy Laboratories, for example, has been under FDA scrutiny for a couple of years, and some of its products still can't be imported into the U.S. One troubled plant may threaten Ranbaxy's chance to launch the first generic version of the megablockbuster Lipitor; in fact, rival generics maker Mylan has sued the FDA for the right to launch its own version ahead of schedule. Meanwhile, Sun Pharmaceuticals has three facilities under FDA investigation, and its compliance problems have hampered filings for agency approval, cutting those applications to 20 to 22 for the year ended in March, rather than the previously expected 30, Reuters says.

"It is going to be extremely competitive," Lupin's Ramesh Swaminathan told the news service. "The FDA will be a lot more diligent." Still, he's convinced that Indian companies will be able to capture their share of the new generics. "Lots of companies are well-geared for exploiting this market," he said. 

- read the piece from Reuters