More Indian firms enter $500-mn US anti-ulcer market

Other pharma giants such as Wockhardt, Dr Reddy's and Natco Pharma have already received US FDA approvals for category

With receiving US FDA nod for generic Lanzoprazole, pharma major Zydus Cadila has entered into the league of generic makers in $500-million US market for anti-ulcer drugs.

On Wednesday, Zydus Cadila has announced that the company has received US FDA approval to manufacture and market Lansoprazole, the generic name for the brand Prevacid, marketed in the United States by Takeda.

Cadila will market Lansoprazole delayed release (DR) Capsules in different strengths of 15 mg and 30 mg.

Other Indian majors such as Wockhardt, Dr Reddy's and Natco Pharma have already received US FDA approvals for Lansoprazole.

Wockhardt received the approval last year to make Lansoprazole. Dr Reddy's launched the drug in May last year.

Though Wockhardt had received US FDA nod in September 2012, the marketing of Lansoprazole delayed release (DR) Capsules is likely to get affected as the export-oriented plant Aurangabad remains under US FDA scanner. Wockhardt had received an import alert from the US drug regulator on the Waluj facility in Aurangabad recently.

Lansoprazole, used for treating ulcers and other conditions involving excessive stomach acid, had estimated sales of $ 501 million in 2012 as per the IMS Health data.

Indian companies are already facing competition in sales of Lansoprazole from other US players such as Perrigo Pharma.