Wockhardt receives ANDA approval for pain medication Oxycodone liquid

22 Jun 2015 Evaluate

Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 5mg/ 5m1 of Oxycodone HCI liquid which is used in treatment of moderate to severe acute and chronic pain. The company is launching the product soon and will be amongst the few generic versions of this product in the market. The company will be manufacturing the Oxycodone HCI liquid at its facility in Morton Grove, IL (United States). The technology for the product was developed in-house.

According to IMS Health, the total market for this product in the US is about $58 million. Oxycodone is used extensively in management of pain, especially in opioid tolerant patients. Wockhardt already markets several other controlled substance products in the United States and generally has a leading presence in the liquid formulations segment. 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 is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s, the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.

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