Dr Reddy’s Laboratories is set to reap the rewards of a significant US generic launch – albeit one with a limited volume caveat decreed by a patent-litigation settlement deal – after it began selling its generic of Bristol Myers Squibb’s multi-billion-dollar blockbuster Revlimid.
Dr Reddy’s has realized plans to introduce the two strengths of its generic version of Bristol Myers Squibb’s multi-billion-dollar blockbuster Revlimid (lenalidomide) in the US for which it holds 180-day generic exclusivity, as part of a complete six-strength offering.
The Indian firm’s launch, including lenalidomide 2
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.
