FDA approves Teva's generic copy of Truvada
- The Food and Drug Administration on June 9 approved Teva’s abbreviated drug application (ANDA) for a generic version of Gilead's HIV combo treatment Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis.
- Although acknowledging the approval, a spokesperson for Teva declined to say when the drug would enter the market, likely due to ongoing patent litigation with Gilead.
- Once several generic versions of Truvada are approved, the cost of the at times controversial combination medicine will likely fall, reducing patient costs.
The approval came after an FDA review indicated the generic was safe, effective, and bioequivalent to Gilead's drug. The FDA’s letter noted Teva could be eligible for 180-day generic drug exclusivity, if any other company applies to market a generic version of Truvada within six months of when Teva begins marketing.
Teva’s generic version of Truvada, however, is not likely to be launched until the patent for tenofovir disoproxil fumarate expires in July of this year, and the patient for emtricitabine expires in 2021. Gilead Sciences retains exclusive’s rights for Truvada’s pediatric use.
"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. DeLuca would not comment on when Teva’s generic version of Truvada would be available, but noted that a confidential legal settlement controlled the drugs entry into the market. Drug companies often develop private legal settlements that set out terms for the near-term availability of generics.
Truvada was approved by the FDA to treat HIV in combination with other antiretroviral drugs in 2004, and Gilead gained approval for the drug to be used as prophylaxis for sexually transmitted HIV in uninfected adults in 2012. The drug has been a successful one for Gilead, and the company earned $2.4 billion in sales from the drug in 2016. Still, uptake of the combination antiretroviral drug among HIV patients has been moderate, and only a small percentage of patients at risk for HIV are currently taking the medicine.
The cost for Truvada has been a barrier to more widespread use. Although Gilead offers patient and copay assistance for Truvada, its cost is a steep $1,500 per month in the U.S. Teva would not comment on how much its generic version would cost once it reaches the market. AIDS advocates expect the drug's cost to fall once several generic versions of Truvada reach the market, potentially improving access for patients.
- FDA Approval letter