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Generic Approvals Reshaping the SP Market

FDA Approvals

For a while we were seeing FDA specialty drugs approvals on a fairly regular basis….. then crickets. Perhaps the hiatus is over with the approval of two new products by TEVA Pharmaceuticals. Don’t get too excited….. they are generic versions of two old drugs.

We usually don’t cover generic approvals…. but it is worth mentioning these two as they are examples of a movement that is slowly picking up steam. In the next few years we will see more generic approvals….. as well as biosimilars that will finally see light of day once legal and patent challenges are behind them.

The other point of interest is that these approvals are in HIV which has seen very few new therapy approvals in recent memory.

So what are they?
The first is a new version of the successful 3 drug combo drug, Truvada. The very long generic name is Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate. As a generic it will come to market at a 70% discount to Truvada.

The second is a 2 drug combo equivalent to Atripla. It goes by Emtricitabine and Tenofovir Disoproxil Fumarate Tablets. Note, that it is the same as Truvada except that it leaves out the Efavirenz which may be supplemented by the physician for another drug.

How can generics impact pharmacy margins?
Specialty pharmacies that dispense the TEVA generic will see revenues drop since the generic price is about 70% lower than the brand. Often times, the spread for a generic is large enough for a pharmacy to realize the same or even greater net profit vs. the brand. It would be tough for the pharmacy to break even with that large a discount to the brand.

Click here to read the full TEVA press release

Are you up to speed on HIV Drug Classes, Single drug, Single pill, and Combination therapies? If not, take a few minutes to refresh your knowledge with this link.

Click here to read the article.

Teva Launches First Generic Versions of HIV-1 Treatments TRUVADA® and ATRIPLA® Tablets in the U.S.

October 02, 2020 — TEL AVIV & PARSIPPANY, N.J.–(BUSINESS WIRE)– Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), today announced the availability of the first Food and Drug Administration (FDA)-approved generic versions of TRUVADA® and ATRIPLA® tablets.

“As the global leader in producing and supplying generics, Teva is excited to launch these medications which further our commitment to delivering more treatment options to patients,” said Brendan O’Grady, Executive Vice President, North America Commercial, Teva. “These products, in addition to our more than 10 HIV-related medications already on the World Health Organization’s Essential Medicines list, represent Teva’s continued pursuit of treatments for HIV to improve health outcomes for the HIV community. During the COVID-19 pandemic, access to treatment is more essential than ever for those who are immunocompromised and at risk of developing more severe disease.”

With 1.2 million people currently living with HIV-1 in the U.S., Teva is committed to increasing access to critical HIV therapies. Despite significant advances in the treatment and prevention of HIV over the last two decades, there are still 12.6 million people globally who are unable to obtain treatment today. With the introduction of these new generic HIV treatment options, Teva strives to further increase access to important therapies.

These newly available generic medicines are indicated for:
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:
Treatment of HIV-1 infection when used with other anti-HIV-1 medicines in adults and children who weigh at least 37 pounds (at least 17 kilograms)
HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (at least 35 kilograms)

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:
Treatment of HIV-1 infection in people who weigh at least 88 pounds (40 kilograms), alone as a complete regimen, or in combination with other anti-HIV-1 medicines
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are both combination treatments available as a single pill with similar safety profiles to their reference products.


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