Generics

Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

Optum Rx, one of the largest PBMs in the US, declared itself as the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

Speaking as Hypera delivered its full year-results, CEO Breno Oliveira has set out plans for the Brazilian firm to launch an Ozempic rival in its domestic market next year. Meanwhile, the company is dealing with increasingly aggressive local generic competition.

Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.

Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.

Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.

Adalvo and CNX Therapeutics have launched the first extended-release formulation of a pregabalin generic in the UK.

Both vexed by bankruptcies and opioid litigation, Endo and Mallinckrodt will merge in a deal valued at $6.7bn. The new company will spin out its generics and sterile injectable business.

Eyeing the lucrative opportunity, three Indian players have launched their generic versions of Boehringer’s anti-diabetes drug Jardiance in their domestic market.

Lupin has moved quickly to begin rolling out the first generic version of the blockbuster blood thinner Xarelto in the US, despite continued legal action over a patent expiring in 2039.

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.

Teva will have to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March, as the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

Lupin and Sun Pharma’s Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer’s blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039.

Sandoz passed a major milestone in 2024, with the firm’s sales for the first time exceeding $10bn on the back of a significant rise in biosimilars turnover. The company is continuing to push ahead with restructuring initiatives and also addressed the potential threat of US tariffs as management discussed the firm’s annual results.

In a wide-ranging conversation, the AAM’s president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting “a much more aggressive communications approach” on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability.

Biocon has announced the UK launch of its liraglutide generic rivals to Victoza and Saxenda, hailing a “significant milestone” for the firm’s GLP-1 business, which it expects to be a major growth driver in years to come.