Zydus gets 180 days shared exclusivity for roflumilast tablets

14 February 2022

Indian drugmaker Zydus, a part of Cadila Healthcare (BOM: 532321), today announced that its US subsidiary has received final approval from the US Food and Drug Administration to market roflumilast tablets in the strength of 500mcg and a tentative approval for roflumilast tablets.

Originated by Forest Labs, roflumilast is currently marketed by UK pharma major AstraZeneca (LSE: AZN) under the tradenames Daliresp and Daxas, having acquired rights for the USA and Canada in 2015.

Zydus Pharmaceuticals (USA), being one of the first applicants for roflumilast tablets, 500mcg is eligible for 180 days of shared generic drug exclusivity under section 505(j)(5)(B)(iv) of the FD&C Act. Zydus’ roflumilast tablets are indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.

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