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.
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
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’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.”
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.
