Indian drug companies Wockhardt and Sun Pharmaceutical Industries have received final approval from the United States Food and Drug Administration (USFDA) to market generic versions of Nicardipine, the hypertension drug.
The approvals are to market generic versions of branded injection Cardene 25mg/10ml, marketed in the US by EKR Therapeutics. The patents covering this product had expired yesterday.
According to drug sales tracking agency IMS, the total market for Nicardipine injection in the US is about $170 million. It is one of the few drugs that are used in injectable form to control hypertension in patients who are unable to receive oral medications.
“The upside for Indian companies may be limited, as the market will be divided between 3 and 4 players. A clear picture will emerge in the coming days, as FDA may give more approvals,” said Ranjit Kapadia, vice-president, institutional equities, HDFC Securities.
“This is our seventeenth sterile product approval in the US, based on a variety of technologies like liquid injections in vials and pre-filled syringes, powder for injection and ophthalmic solutions,” said Wockhardt Chairman Habil Khorakiwala.