FDA Approves Generic PrEP — But When Will It Be Accessible?

The FDA has just approved generic Truvada, a highly effective HIV prevention drug. As a result, the price of PrEP could fall dramatically in the U.S. — but probably not in the near future.

Over the past week, the FDA announced formal approval for Teva Pharmaceutical Industries to produce the first generic version of Truvada — a combination of drugs emtricitabine and tenofovir disoproxil fumarate — in the U.S.

Truvada, an HIV prevention and treatment drug from Gilead Sciences, has been the subject of ongoing clinical studies due to its highly potent ability to prevent HIV infections in at-risk groups who can adhere to a daily schedule. In fact, studies have shown the drug’s effectiveness to range from 70 to 90 percent or more in preventing the main strain of the virus, known as HIV-1.

Truvada — often referred to simply by its umbrella group PrEP — is unfortunately quite pricey, at least at first glance.

The drug costs about $1,540 per month for 30 tablets taken one per day. Obviously, with insurance a patient would only pay a small proportion of that price. But it is undeniable that the cost of PrEP remains high in the US.

Generics could drive that cost down significantly — and we have the comparative data to prove it.

While patents have meant that, until now, Truvada generics couldn’t be marketed in the U.S., the FDA has approved them for sale in other territories. For example, Medscape notes that in 2013 the FDA approved Strides Arcolab Limited in India to create a generic form of the drug under the White House’s AIDS and HIV prevention and relief program.

While looking at other markets cannot provide a direct comparison, the contrast in price is stark enough to indicate that there is room for costs to fall: Generic versions of the drug in other countries is available for as little as $70 per year–not the $18,000 that the U.S. market offers.

While the U.S. drug market is unlikely to let costs fall that much, some estimates suggest an 80 percent reduction.

So all this should mean that generic Truvada is about to hit the shelves soon, right? Unfortunately, that’s not the case.

Gilead told HIV/AIDS community site POZ that “[a] generic form of Truvada will not be immediately available” and explained that there are several factors influencing the introduction of generics to the market.

Chiefly, while Gilead’s patent on tenofovir disoproxil fumarate runs out in July of this year, its patent on the emtricitabine component doesn’t expire until 2021. 

As POZ details, the FDA may yet speed this process along because it is possible for generics companies to apply for patents to be invalidated, though it remains unclear if that will happen in this case. 

But Teva and Gilead may work out their own agreements for how the generic will be marketed — and, crucially, when. Campaigners will want a fully fleshed-out plan so that access to the drug isn’t disrupted by, say, Gilead ending its assistance programs. Luckily, Gilead appears to recognize the importance of the programs, aiming to maintain them and continue serving the community.

If it sounds like there is some tension surrounding this topic, you’d be right.

Drug companies have a long history of holding the LGBT community to ransom through HIV drug pricing. Indeed, the infamous 2015 case of Turing Pharmaceuticals raising the price by more than 4,000 percent on a generic drug used by some people with HIV is just one modern example.

But the fight over the cost of HIV medication goes back to the very heart of the AIDS crisis, leading to protests as recently as just last year. And concerns about Gilead’s pricing of new HIV medications rumble on today.

It’s also part of a wider mistrust surrounding drug pricing, which — with no caps and no compelling transparency laws — continues to be far higher in the U.S. than other nations of similar economic power.

As such, campaigners are eager for a transparent process that will bring generic Truvada to the U.S. market as quickly as possible.

Given that LGBT people, and in particular LGBT people of color, continue to face disproportionately high rates of HIV infection, making sure that this prevention tool is widely and cheaply available is an absolute must if we want to stamp out new HIV infections for good.

Photo credit: Jason.

29 comments

Mike R
Mike Rabout a month ago

ty

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Mike R
Mike Rabout a month ago

ty

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Mike R
Mike Rabout a month ago

ty

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Philippa P
Philippa Powers3 months ago

Thanks.

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Karen H
Karen H4 months ago

Big Pharma strikes again. If it doesn't make them big bucks, they're not interested - no matter how many people die.

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Carl R
Carl R4 months ago

Thanks!!!

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Margie F
Margie FOURIE4 months ago

After a patent of 20 years? I think a more recent drug would be useful.

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Danuta W
Danuta W4 months ago

Thanks for sharing

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Liliana Garcia
Liliana Garcia4 months ago

Is a vaccine the same as a "prevention drug"? Wahat the USA allows to big pharma is tantamount to a violation of human rights!

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Anne M
Anne Moran4 months ago

Bring on the generics !! - $5.00 a pill,, $1,540.00 a month is astronomical !!

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