Pharma major Wockhardt on Friday said it has received tentative approval from the US

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health regulator to market generic Duloxetine Hydrochloride capsules, used for treating depression, in the American market.

“The company can get incremental revenues to the extent of $50 million (Rs 223.68 crore) within one year,” said a senior analyst with a leading brokerage house in India who could not be named due to compliance issues.

"Wockhardt was amongst the first to file companies with a paragraph-IV certification for Duloxetine DR capsules. We will be amongst the first to market this product, as and when the generic market opens up," said Wockhardt Chairman Habil Khorakiwala in a press release.

The tentative approval by the United States Food and Drug Administration (USFDA) is for marketing Duloxetine Hydrochloride delayed release capsules in strengths of 20 milligrammes (mg), 30 mg and 60 mg, the company said.

"According to IMS Health, the total market for this product in the US is about $ 3.3 billion (Rs 14,762.9 crore),'" said Wockhardt.

The patent covering this product is under litigation in the US courts and the company will launch the product after resolution of the litigation, Wockhardt said in a statement.

Eli Lilly and Co holds the patent for the drug, which is marketed under the brand Cymbalta in the United States. Duloxetine is one of the most widely used drugs in treating depression and generalised anxiety disorder, added the release.

"The company will be manufacturing the Duloxetine HCL API at its FDA approved facility at Ankleswar, in Gujarat, and capsules at its facility in Aurangabad," it added.

Shares of Wockhardt closed 0.5 per cent down at Rs 396.05.