US approval for prostate cancer formulation and impotence generics

Generics/News | Posted 22/06/2018 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has approved generics of tadalafil, used to treat male impotence, and a new abiraterone formulation, a treatment for prostate cancer.

29 MD002351

A generic of Eli Lilly’s erectile dysfunction drug Adcirca/Cialis (tadalafil) from Israeli generics giant Teva Pharmaceutical Laboratories (Teva) was approved by the FDA on 22 May 2018. FDA has also granted tentative approval for tadalafil generics from Indian generics makers Alembic Pharms, Aurobindo Pharma and Sun Pharma, as well as to US-based Synthon Pharms and Watson Labs, and China-based Yangling Buchang Pharma.

Cialis has generated more than US$17 billion in sales during its patent life, which now extends at least until 27 September 2018, with some patents only expiring in 2021. Cialis also has paediatric exclusivity which will only expire in 2021.

Sun Pharma also announced on 23 May 2018 that it had gained FDA approval for Yonsa (abiraterone), a drug containing the same active ingredient as Zytiga (abiraterone). Yonsa is approved in combination with methylprednisolone to treat patients with metastatic castration-resistant prostate cancer (mCRPC). This avoids infringing on Johnson & Johnson’s (J&J) patents for Zytiga, which is approved for use with a different steroid, prednisone, to treat patients with mCRPC and high-risk castration-sensitive prostate cancer. Zytiga had US sales of US$1.23 billion in 2017.

J&J lost a patent challenge on Zytiga in January 2018 but is still holding out for a reprieve and said that it will be asking ‘for a rehearing at the Patent Trial and Appeal Board or will appeal to “vigorously” defend its patent’. The company is still somewhat protected against Zytiga generics in the US, as more than half of its sales are generated outside the US.

Related articles
Teva launches ulcerative colitis generic in the US

Sun Pharma launches imatinib mesylate in the 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.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: BioSpectrum India, Sun Pharma, US FDA

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