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Sun Pharma and Dr Reddy’s generics progress in EU and US

Generics/News | Posted 05/11/2021 0 Post your comment

October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) meeting of 11–14 October 2021 granted a positive opinion regarding the generic Sitagliptin SUN (sitagliptin fumarate). This Sun Pharmaceutical product is a generic version of Januvia and is an anti-diabetic medication used to treat type 2 diabetes.

In the US, Dr Reddy’s Laboratories obtained Food and Drug Administration (FDA) approval for generic lenalidomide capsules, in 2.5 mg and 20 mg strengths. This is a generic of Celgene’s Revlimid and Dr Reddy’s approved lenalidomide capsules are now eligible for 180 days of generic drug exclusivity. In addition, Dr Reddy’s received tentative approval for the product in 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is used to treat adult patients with multiple myeloma.

This announcement came following a patent litigation between Dr Reddy’s and Celgene, that was settled in September 2020.

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