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Generic Drugs

Teva’s Estradiol Approved As The First Generic To Imvexxy By The FDA

The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.

Tyzavan Launch Marks Next Step In Hikma’s Global Injectables Growth Strategy

The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.

US Government Fights Hikma’s Corner In Skinny Label Vascepa Row

“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.

German Giants Rise Up The Ranks In Generics Bulletin’s Top 50

Two leading German generics and biosimilars giants are the big movers at the top of our annual ranking of off-patent industry leaders. We reveal the latest developments in this year’s Generics Bulletin Top 50.

Europe Leads Charge As Private Equity Roars Back Into Off-Patent Pharma

A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.

FDA Publishes PSGs For GLP-1 Giants Mounjaro, Wegovy, Victoza/Saxenda

The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.

Hopewell Told Delay Is ‘Of Its Own Making’ As Cladribine Stay-Lifting Bid Fails

Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.

GDUFA Costs ‘Destroy Economics’ Of Onshoring Generics, Cuban Warns

Cuban argues that user fees under the GDUFA program are deterring domestic production of generics, according to reports.

David And Goliath: How A Parent-Led Buyers’ Club Challenged Cystic Fibrosis Giant Vertex

After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.

Reddy’s To Keep Producing Semaglutide In India As Novo Denied Interim Relief

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

EPO Appeal Board Strikes Down Biogen’s European Tecfidera Patent

EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.