1. Generics Bulletin
  2. >>Products

Amneal Ready To Go Head-To-Head With Mylan’s Xulane In US

Gains 180 Days Of CGT Exclusivity For Generic Of Ortho Evra Contraceptive Patch

 
• By Dave Wallace

Amneal is set to benefit from 180 days of US exclusivity for its norelgestromin and ethinyl estradiol contraceptive patch product after receiving FDA approval with a competitive generic therapy designation. The generic will be the only competitor to Mylan’s Xulane version.

Number 180 red white
Amneal will benefit from 180 days of CGT exclusivity • Source: Shutterstock

Amneal has received approval for and is launching today its US generic version of Janssen’s Ortho Evra (norelgestromin/ethinyl estradiol) 150mcg/35mcg contraceptive patches.

The firm is set to benefit from 180 days of exclusivity after the US Food and Drug Administration approved the product – which will be marketed under the Zafemy brand name – with a competitive generic therapy designation

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Products

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.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By Dave Wallace

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

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.

More from Generics Bulletin

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By Dave Wallace

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Teva To Slash Thousands Of Jobs And Shut More Sites Under $700m Savings Plan

 
• By Dean Rudge

Teva’s plans to generate net savings of $700m by 2027 have been described by the firm as a journey and not a destination, with the suggestion that “this era of cost efficiency, harmonization, frugality will continue.”

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.