🏳️‍🌈✝️ FDA Approves Generic Truvada for HIV Treatment and PrEP

Contradicting FDA officials, Gilead Sciences, the brand-name manufacturer of Truvada, insists a generic version “will not be immediately available.”

  By Benjamin Ryan 

 June 9, 2017

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In a move that has taken HIV advocates by considerable surprise, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster antiretroviral (ARV) Truvada (tenofovir disoproxil fumarate/emtricitabine). This decision could have major implications for the future cost of Truvada, to insurers and consumers alike.

However, Gilead insisted in a statement, “A generic version of Truvada will not be immediately available. It’s important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval.”

The statement noted that the patent for the tenofovir disoproxil fumarate component of Truvada expires in July 2017 and that Gilead retains exclusive rights for the drug's pediatric use until January 2018. Meanwhile, the patent for emtricitabine, the other medication in Truvada, does not expire until 2021, according to Gilead.

The FDA approval grants Teva Pharmaceuticals the right to produce generic Truvada for the combination tablet’s use as a component of an HIV treatment regimen and as pre-exposure prophylaxis (PrEP). Generic Truvada would come in the same form as the brand-name version: as a fixed-dose combination tablet, although the famous powder-blue color may change.

“Yes, the first generic for Truvada has been approved and will now be available in the U.S.,” Jeffrey S. Murray, MD, MPH, deputy director of the Division of Anti-Viral Products at the FDA, tells POZ, contradicting Gilead’s claim. “Usually, it takes several generics before full cost-savings potential is reached though. Hopefully, this will help to expand PrEP availability for many.”

Tim Horn, deputy executive director of HIV and HCV programs at Treatment Action Group, offers insight that may help reconcile the contrasting claims between Gilead and the FDA with regard to generic Truvada’s availability. “It’s important to understand that approval of a generic product doesn’t necessarily mean that product launch is imminent,” Horn says. “Generic Viread [tenofovir disoproxil fumarate], for example, was approved by the FDA in 2015, yet we don’t expect this to be launched in the U.S. until early 2018.

“It’s not uncommon in patent settlement agreements for generics to negotiate language permitting full approvals months and years in advance of the settlement license date,” Horn continues. “Regardless, now is the time to start thinking seriously about the advantages, as well as the drawbacks, of generic products to prevent and treat HIV.”

According to Murray, it remains unclear what sort of exclusivity Teva may have to produce generic Truvada. Generic manufacturers often hold such exclusive rights for an initial period before competitors can also begin producing a particular generic medication and thus drive down prices. Murray stated that clarity on Teva’s rights in this regard may not come for several months.

As discovered by activist James Krellenstein, a June 5 FDA document added Truvada to the agency’s list of medications that have been granted what is known as a paragraph IV patent certification. Such a designation indicates that a drug patent “is invalid or not infringed by the drug product” proposed as a generic equivalent. Truvada’s addition to this list raises questions about the validity of Gilead’s claims that emtricitabine’s patent in particular will stand for another four years.

A Teva spokesperson confirmed the generic Truvada approval but said no further related information was available at this time.

“While this is stunning news that AIDS activists didn’t expect until 2021, I’m worried about the fallout,” says ACT UP and Treatment Action Group veteran Peter Staley. “Gilead’s patient and copay assistance programs have become central pillars in patient access. They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version.”

Signs look promising that Gilead will continue supporting PrEP use among individuals at risk for HIV. According to the company's statement, “Gilead believes Truvada for PrEP is an important HIV prevention tool and we remain committed to helping ensure access to our medications for people both at risk of or living with HIV.”

To see the FDA generic approval page, click here.

To read a collection of POZ articles on pre-exposure prophylaxis, click #PrEP, which includes the feature stories “PrEP: A Dream Deferred,” about how the prevention pill is failing to reach Black men who have sex with men; “Positive on PrEP,” a profile of three men who contracted HIV after starting PrEP; and “A Tale of Two Cities,” about the efforts of New York City and San Francisco to end their HIV epidemics. To learn the basics about PrEP and PEP, click here.

Read more articles from POZ, here.