First generic Sustiva tablets launched in USA

1 February 2018

Netherlands-incorporated Mylan (Nasdaq: MYL) today announced the US launch of efavirenz tablets USP, 600mg.

Mylan says this is the first generic version of Bristol-Myers Squibb's (NYSE: BMY) Sustiva. The product is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) type 1 infection in adults and in pediatric patients at least three months old and weighing at least 3.5kg.

According to the Food and Drug Administration approval letter, Mylan was one of the first applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) for efavirenz tablets USP, 600mg, containing a Paragraph IV certification, and is eligible for 180 days of generic drug exclusivity. The drug had US sales of around $113 million for the 12 months ending December 31, 2017, according to IQVIA data quoted by Mylan.

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