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to Section One | to Arts & Entertainment
posted Friday, June 16, 2017 - Volume 45 Issue 24
FDA approves generic Truvada
Section One
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FDA approves generic Truvada

by Mike Andrew - SGN Staff Writer

The Food and Drug Administration (FDA) has approved the first generic version of Truvada.

In a June 9 announcement, the federal agency said the Teva pharmaceutical company could sell its new emtricitabine and tenofovir disoproxil application. Truvada is a brand name owned by Gilead, which has marketed the drug since 2004.

Truvada is now one of the standard treatments for HIV-1 infection and is also prescribed in a PrEP application to prevent HIV infection. It has been found to be 98% effective as a PrEP drug.

According to the QuintilesIMS Institute's 2017 Medicine Use and Spending in the U.S. report, Truvada had $3.1 billion in sales in 2016, ranking 17th among the top 20 medicines in the United States. The drug has seen more than $2 billion in sales since 2012, with the highest sales coming in 2016.

Generic drugs are usually cheaper than brand-name ones, so a generic Truvada could be a great benefit to a both HIV-positive people and HIV-negative people at risk for HIV infection.

According to Medscape, the price of Gilead's Truvada is about $1,500 per month, or $18,000 per year, for the one-pill-daily dose prescribed for PrEP, with insurers and patient assistance programs covering much of the cost.

The price of the generic version hasn't been announced, but Mitchell Warren, executive director of the HIV prevention organization AVAC, told Medscape that a generic drug will likely reduce the cost of PrEP by 80%. Generic versions of Truvada sold overseas have a price tag as low as $70 a year, he told the site.

'This is an exciting day,' Warren told Medscape. 'We've seen momentum for PrEP programs and policies. Having a lower-cost alternative will only increase that momentum.'

He added that he expects other pharmaceutical companies to launch generic versions of Truvada as well.

However, the date when the generic drug will be available to consumers is not yet certain. Teva did not immediately respond to a request for information, and Gilead issued a statement to Poz magazine asserting that the generic version can't be marketed right away because it still holds patents on Truvada's components.

Tim Horn of Treatment Action Group told Poz, 'Approval of a generic product doesn't necessarily mean that product launch is imminent.... 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. 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.'

Activists said they hoped that Teva will offer patient assistance programs for the generic drug, as Gilead does with Truvada.

'Gilead's patient and copay assistance programs have become central pillars in patient access,' veteran activist Peter Staley told Poz. 'They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version.'

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