Biocon and Lupin launch generic tacrolimus capsules in US

Generics/News | Posted 05/02/2021 post-comment0 Post your comment

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

Transplant2 AA010142 V13K22

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.

Related articles
Cost savings after switching to generic tacrolimus

Follow-up study finds generic tacrolimus safe for kidney transplant patients


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

Source: Biocon, Lupin

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010