Wockhardt has received final approval from the US FDA for marketing 15 mg and 30 mg delayed release capsules of lansoprazole, which is used in treatment of peptic ulcers. Lansoprazole is the generic name for the brand Prevacid, marketed in the US by Takeda. Wockhardt is launching the product immediately.
Dr Habil Khorakiwala, founder chairman and group CEO, said, “Lansoprazole delayed release formulation is a very challenging product and it once again demonstrates Wockhardt R&D's capability in the NDDS technology space. We have received eight ANDA approvals in the past 30days and four of them have been products that involved significant technology in formulation.”
According to IMS Health, the total market for this product in the US is about $700 million. Proton Pump Inhibitors like lansoprazole are the mainstay of treating ulcers worldwide. Wockhardt already markets an over-the-counter version of 15mg lansoprazole DR capsules in the US.
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many, instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.
It will be manufacturing the lansoprazole API at Ankleshwar and the delayed release capsules of lansoprazole at its facility in Aurangabad.