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 |