Generic Drugs

Generics Bulletin reviews global regulatory developments across the world.

Decision matches earlier Dr Reddy’s outcome, although no injunctive action involved, allowing exports to non-patent markets ahead of a post-expiry launch.

Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.

After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.

After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.

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.

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.

“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.

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.

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.

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

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