Zydus Cadila and Sandoz generics approvals in North America

Genéricos/Novedades | Posted 31/05/2021 post-comment0 Post your comment

In April 2021, Zydus Cadila received final approval from the US Food and Drug Administration to market its ibrutinib and macitentan generics. In addition, in May 2021, Sandoz Canada announced the launch of their pirfenidone, a generic version of F. Hoffmann-La Roche’s Esbriet®.

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US approvals
Following the recent approvals, Indian multinational, Zydus Cadila will now launch ibrutinib capsules (70 mg and 140 mg) and macitentan tablets (10 mg).

Ibrutinib is a kinase inhibitor and is used to treat certain cancers, including mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia. Zydus was the first abbreviated new drug application (ANDA) applicant to submit a substantially complete ANDA with a paragraph IV certification for the 70 mg product and will thus receive 180 days of generic drug exclusivity for this product. For the ibrutinib capsules, 140 mg, they will have 180-days of shared generic drug exclusivity.

Macitentan is an endothelin receptor antagonist used to manage the symptoms of pulmonary arterial hypertension. As one of the first ANDA applicants, Zydus is also eligible for 180 days of shared generic drug exclusivity for its macitentan tablets, 10 mg.

Canadian approval
Sandoz is the first manufacturer to launch a generic pirfenidone product. This is indicated in the treatment for idiopathic pulmonary fibrosis in adults. The product will now mainly be sold at the community pharmacy level and will be available as 267 mg tablets in bottles of 21 or 270 tablets, and as 801 mg in bottles of 90 tablets.

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