Generic challenges relating to Zytiga and Abilify

18 August 2015

Netherlands-incorporated Mylan (Nasdaq: MYL) has confirmed that it has been sued by BTG (LSE: BTG) and Johnson & Johnson (NYSE: JNJ) subsidiaries Janssen Biotech, Janssen Oncology and Janssen Research & Development in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for abiraterone acetate tablets, 250mg.

This product is the generic version of J&J’s Zytiga, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs have filed a law suit against Mylan in the US District Court for the District of New Jersey.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK