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Indian Pharma’s El Dorado
Over the next two years, a $47-billion opportunity awaits pharmaceutical players in the USAs key drug brands go off-patents

The hour of reckoning is at hand for the Indian pharmaceutical industry. According to domestic brokerage house Dolat Capital, domestic players are expected to leverage on the addressable pharma market worth $47.5 billion in the US as major drug brands are set to lose their patent protection over the next two years. Given that the US is looking at reducing its budget expenditure on healthcare, the government is supporting generic competition. This will be a major growth driver for leading Indian pharma players, who will also be aided by a depreciating rupee. According to analyst Bhavin Shah, key brands such as Plavix, Lexapro, Actos and Diovan are set to go off-patent this fiscal. Though Indian companies have been preparing to tap the market for these brands over the past decade, only a handful of players have managed to get regulatory compliance. Given Ranbaxy’s issues with the US FDA, for now Dr Reddy’s and Lupin stand to gain based on their pipeline of launches over the next 12 months. However, it won’t be a cakewalk for the players as innovators (who hold the patent rights) will adopt aggressive strategies to limit generic penetration. A case in point is Pfizer, which started offering huge discounts in the case of Lipitor when it went off-patent in November 2011, while Dr Reddy’s holds first-to-file rights.

Innovator Brand addressable market ($ mn) Treatment Indian players

Bristol-Myers Squibb/Sanofi Plavix 5,961 Anti-platelet agent DRL, Sun, Torrent
Pfizer Lipitor 5,329 Cholestrol lowering Ranbaxy (launched), DRL
AstraZeneca Seroquel 4,000 Schizophrenia Dr Reddy’s
Eli Lilly Cymbalta 3,500 Depression Multiple players (7)
Takeda Actos 3,312 Diabetes Ranbaxy#, Torrent, DRL, Wockhardt, Aurobindo
Merck Singulair 3,200 Asthma/COPD Glenmark, Torrent
Novartis Diovan 2,520 Hypertension Ranbaxy
Eli Lilly Zyprexa 2,495 Schizophrenia Dr Reddy’s (launched), Torrent
Forest Labs Lexapro 2,259 Anti-depressant Sun, Dr Reddy’s, Lupin, Cadila, Torrent
Pfizer Lyrica 1,424 Anti-convulsant Lupin, Sun
Sanofi Eloxatin 1,400 Colorectal cancer Strides, Sun
PFE Geodon* 1,340 Schizophrenia Lupin, DRL
ABT TriCor 1,300 Blood-thinning drug Ranbaxy#, Lupin
Johnson & Johnson/Eisai Co Aciphex 1,185 Gastroesophageal reflux disease Dr Reddy’s
Abbott Niaspan 1,000 Cholesterol lowering Sun
Cephalon Provigil 961 Narcolepsy Ranbaxy#, Sun, Aurobindo, Alembic
Sunovion Pharmaceuticals Lunesta 787 Insomnia Glenmark, Orchid, Sun
Novartis Zometa 721 Cancer-related bone loss Sun, Dr Reddy’s
Sanofi/Bristol-Myers Squibb Avapro/Avalide 588 Hypertension Cipla, Lupin, Cadila, Alembic
GSK Boniva 506 Osteoporosis

Sun, Orchid, Dr Reddy’s

*Recently launched; Launch uncertain as per the terms of the US FDA consent decree
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