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US approval for prostate cancer formulation and impotence generics Posted 22/06/2018

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.

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.

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Source: BioSpectrum India, Sun Pharma, US FDA

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