Generic Drugs

The US-India dance on pharma goes on as they announce a trade deal framework that continues to exempt generics from the reduced 18% tariffs till a “negotiated outcome” is reached post a Sec. 232 investigation. However, oil imports from US could increase costs for pharma

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.

After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.

Strides Pharma aims for higher revenues from Canada and other ex-US markets while waiting for controlled substances to ramp up gradually under the leadership of ex-Apotex CEO Peter Hardwick. However, a cut in US funding for the Global Fund is hurting the company and its competitors.

Slovenia’s Krka is ramping up capital spending to expand global manufacturing capacity, betting that industrial scale and supply resilience will drive its next phase of growth.

With another settlement secured, US states are gearing up for the first trial of the price-fixing case later this year.

The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.

Sales set to rise at low single digits this year but profits will be down slightly as generics take a grip on big earners like Entresto.

BC Partners has completed its acquisition from Servier of French generics giant Biogaran after the French government allowed the private-equity takeover on condition that BPI France take a minority stake. Meanwhile, former Biogaran CEO Erick Roche has returned to the role after a long stint at Teva.

Transpire Bio continues to advance its complex generics franchise, with another Paragraph IV filing for GSK’s Ellipta portfolio inhaler.

The US Association for Accessible Medicines has named Lupin’s Bob Hoffman as its new chair. Meanwhile, departures have been seen at Stada and Dr Reddy’s, among other industry management changes.

Generics Bulletin previews the most noteworthy and anticipated events for February 2026.