Drug-maker Wockhardt has said it will sell its generic version of Pantoprazole in the United States, following the expiry of the patent on the drug.
Pantoprazole, used to treat gastro-intestinal ulcers and hyperacidity, is estimated to have grossed $ two billion in the US. Sold under the brandname Protonix by Pfizer-Wyeth, the patent on the product expired on Jan 19, 2011.
Dr Reddy’s Laboratories is also in the same boat, having launched the generic version of the product, earlier this week, after the patent expired. And while more generic versions of this drug are expected to be in the line-up for launch in the US – interestingly, a spokesperson for Sun Pharma said it would look to sell the generic version of the product in the US, with no incremental risk.
Sun was involved in litigation over the product and had even launched it at risk in the US. But following a ruling that went in favour of Pfizer and Altana’s patents on the drug, Sun stopped selling the product mid last year.
The patent on the drug is held by Altana (now under Nycomed) and the product had been licensed to Wyeth – a company acquired by Pfizer.
Patents allow a company exclusive sales of a product for 20 years and on expiry of the patent, other companies are legally allowed to make similar versions of the product.
Two Indian companies have already got regulatory approval to sell the generic product in the US, and several more will be in the pipeline, said Mr Ranjit Kapadia of HDFC Securities.
As a result, the price of the product will fall by about 90 percent from the innovator’s price. Sun Pharma will have to take a call on whether to sell now at these reduced prices, against the backdrop of the litigation, he added. The litigation on the “at-risk” sale of the product by Sun, before the patent expired is yet to come to a close.
Wockhardt, meanwhile, said, it received regulatory approval from the US Food and Drug Administration (US FDA) for marketing 20 mg and 40mg strengths of Pantoprazole Delayed Release tablets. The tablets will be manufactured at Wockhardt’s formulation plant at Waluj, Aurangabad and the Pantoprazole sodium API will be manufactured in the FDA certified API plant at Ankleshwar, Gujarat.