Biocon and Lupin launch generic tacrolimus capsules in US Posted 05/02/2021

India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.

Biocon announced its launch of generic tacrolimus capsules in the US on 28 December 2020. The launch follows an approval from FDA in November 2020.

Lupin announced on 25 November 2020 that it had launched tacrolimus capsules at doses of 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech (Concord) received an approval for its abbreviated new drug application (ANDA) from the US Food and Drug Administration (FDA).

Tacrolimus, a calcineurin inhibitor, is an immunosuppressant used in the treatment of organ transplant patients. It reduces the body’s ability to reject a transplanted organ and has been used for the treatment of renal transplant patients for more than two decades.

The products from Biocon and Lupin are generics of Astellas Pharma’s Prograf (tacrolimus) and are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant and heart transplant, and in paediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants.

Prograf (0.5 mg, 1 mg, and 5 mg) had annual sales of approximately US$303 million up to September 2020 in the US, according to the IQVIA Institute.

The European Medicines Agency recommended approval of Teva Pharmaceutical’s tacrolimus generic Tacforius on 12 October 2017 [1]. This was followed by European Commission approval in December 2017.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for tacrolimus generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Generics/News/EMA-approval-for-tacrolimus-generic

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Source: Biocon, Lupin

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