Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 15mg 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 United States by Takeda. Wockhardt is launching the product immediately.
"Lansoprazole delayed release formulation is a very challenging product and it once again demonstrates Wockhardt R&D's capability in the NDDS technology space," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "We have received eight ANDA approvals in the past 30-days and four of them have been products that involved significant technology in formulation," he said.
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.
Wockhardt will be manufacturing the Lansoprazole API in its facility at Ankleshwar, India and the delayed-release capsules of Lansoprazole at its facility in Aurangabad, India. The technology for the API and the capsules were developed in-house.
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