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Teva Takes Aim At First Truvada And Atripla Generics In US

Israeli Firm Set For ‘Some Exclusivity’

 
• By Dean Rudge

Teva has secured one of the largest tablet formulation opportunities in the US with the launch of the first generics to Gilead Sciences’ Truvada, including for HIV-1 PrEP, at the same time introducing a version of the triple-combination Atripla. Collectively the brands had sales north of $3bn last year.

Gilead
Teva became the first ANDA sponsor to introduce generics to Gilead's Truvada and Atripla • Source: Shutterstock

Teva has introduced in the US the first generic versions of Gilead Sciences’ linchpin antiretrovirals, the double-combination Truvada (emtricitabine/tenofovir disoproxil) and triple-combination Atripla (emtricitabine/tenofovir disoproxil/efavirenz) tablets, bolstering efforts “for those who are immunocompromised and at risk of developing more severe disease” considering the COVID-19 pandemic.

The Israeli firm’s announced launch was slightly behind a 30 September 2020 launch date provided under a settlement agreement with the originator, as revealed in Gilead’s recent

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Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

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Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.