Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Teva’s Generic HIV Drug Gains FDA Approval



The approval letter sent to Teva confirms that they were the first generics maker to file an abbreviated new drug application (ANDA) for the HIV treatment.

Share this!

June 16, 2017 | by Sarah Hand, M.Sc.

The FDA has approved Teva Pharmaceutical’s generic version of Gilead’s HIV drug, Truvada, (emtricitabine/tenofovir disoproxil fumarate). The drug is used as a prophylactic in people at high risk of contracting HIV.

While the regulator acknowledged that the generic was bioequivalent to the branded drug, it’s unclear exactly when the pre-exposure prophylactic will be available on the market. According to an article on BioPharmaDIVE, the delay in the launch of the combo treatment is “likely due to ongoing patent litigation with Gilead.”

The approval letter sent to Teva confirms that they were the first generics maker to file an abbreviated new drug application (ANDA) for the HIV treatment. As such, they may be entitled to a 180-day exclusivity period during which time other generic competitors will not be able to apply to market their version of Truvada.

“We are pleased with the FDA’s decision and look forward to supporting these (HIV) patients with generic medicines when we are otherwise able to,” said Elizabeth DeLuca, associate director of global generic medicines and North America for Teva. Gilead carries a number of patents for the combination therapy which expire between 2018 and 2024.

In 2004, Truvada was originally approved as a treatment for HIV. Eight years later, the FDA approved the drug as a preventive treatment for uninfected adults at risk of contracting HIV.

While the drug hasn’t been adopted by all people who would be eligible to use it prophylactically, Gilead reported that approximately 125,000 people in the US were taking Truvada as of Q1 2017. Truvada sales in the US reached $2.4 billion in 2016, with global sales of $3.5 billion.

Gilead has faced criticism over the price of Truvada, which comes in at $1,500 per month, and some believe that this is one of the primary deterrents that is preventing more widespread use of the drug. Launch of Teva’s generic Truvada could go a long way to making this prophylactic treatment more affordable and accessible to patients.

Keywords:  HIV, FDA, Generic


Share this with your colleagues!

German Merck Launches Spinoff Immuno-Oncology Company

June 22, 2017 - Merck KGaA has announced the launch of iOnctura SA, a new immuno-oncology company built around two assets from the Healthcare R&D portfolio of the pharmaceutical company.

Featured In: Biotech News

Ikea Promotes Food Products by Offering Fill-in-the-Blanks Recipe Sheets

June 21, 2017 - In an effort to promote the company’s food business, Ikea recently launched a set of recipes printed on parchment paper that encourage consumers to “fill-in-the-blanks” with ingredients, fold the paper and cook the bag in the oven.

Featured In: Food News

Nanomaterial Promotes Bone Growth after Spinal Fusion Surgery

June 21, 2017 - Researchers at Northwestern University have developed a bioactive nanomaterial capable of effectively stimulating bone regeneration after spinal fusion surgery.

Featured In: Life Science News


Top 5 Most Impactful Tweets in Drug Development During the Last Week


Serialized? Yes. But are Products Still Being Diverted?

Quantitative Protein Profiling in FFPE to Characterize Toxicities Associated with Immune Checkpoint Inhibitors

Are You Choosing the Right Model? A Guide to Selecting Your Next Immuno-Oncology Model

Imaging-based Subtypes of Pancreatic Cancer

Copyright © 2016-2017 Honeycomb Worldwide Inc.