US generics launch and approval for Dr Reddy’s and Lupin

Generics/News | Posted 21/10/2022 post-comment

0 Post your comment

On 7 September 2022, Dr Reddy’s Laboratories (Dr Reddy’s) announced the US launch of their generic lenalidomide capsules. And in July 2022, Lupin announced that its generic azilsartan medoxomil tablets had been approved by the US Food and Drug Administration (FDA).

Dr Reddy’s Laboratories lenalidomide capsules are a generic equivalent of Celgene’s Revlimid and are eligible for first-to-market, 180 days of generic drug exclusivity for capsules in 2.5 mg and 20 mg. They are also available as 5 mg, and 10 mg, and 25 mg strengths. The launch comes following FDA approval in late 2021 [1]. Lenalidomide is an oncology drug product for the treatment of adult patients with multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma. Revlimid was first launched in Europe in 2006 by Celgene that was subsequently acquired by Bristol Meyers Squibb. Revlimid is a blockbuster drug, generating US$12.8 billion for Bristol Meyers Squibb in 2021 [2].

Lupin’s newly approved azilsartan medoxomil tablets are a generic version of Azurity Pharmaceuticals Inc.'s Edarbi tablets. This product is used to treat high blood pressure and will soon be made available to patients in the US. It joins Lupin’s other generic and biosimilar products that have been approved by FDA. Lupin’s generic products include: emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV [3], tacrolimus capsules that are a calcineurin inhibitor and an immunosuppressant used in the treatment of organ transplant patients [4], and empagliflozin for diabetes treatment [5].

EMA recommends approval of Lenalidomide Mylan

Dr Reddy’s buys Wockhardt plant and Strides acquires 18 ANDAs

Alvogen receives European approval for generic lenalidomide

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

Browse the news in the Latin American Forum!

FORO LATINOAMERICANO

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. Sun Pharma and Dr Reddy’s generics progress in EU and US[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/generics/news/Sun-Pharma-and-Dr Reddy’s-generics-progress-in-EU-and-US
2. GaBI Online - Generics and Biosimilars Initiative. Revlimid (lenalidomide) generics launch across Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/generics/news/revlimid-(lenalidomide)-generics-launch-across-europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/generics/news/fda-approval-for-schizophrenia-and-hiv-generics-from-zydus-cadila-and-lupin
4. GaBI Online - Generics and Biosimilars Initiative. Biocon and Lupin launch generic tacrolimus capsules in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/generics/news/Biocon-and-Lupin-launch-generic-tacrolimus-capsules-in-US
5. GaBI Online - Generics and Biosimilars Initiative. Lupin’s generic diabetes drug approved and asthma drug launched in US[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 21]. Available from: www.gabionline.net/generics/news/Lupin-s-generic-diabetes-drug-approved-and-asthma-drug-launched-in-US

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.