BUSINESS

Solo Januvia Generic Approval Likely Exploited Patent Loophole, Litigation Possible?

By Takashi Ebisawa and Ken Yoshino August 18, 2023
Sawai Group Holdings likely took advantage of a loophole in patent extensions in obtaining solo generic approval for MSD’s major DPP-4 inhibitor Januvia (sitagliptin), Jiho has learned. Due to the ambiguity in patent extension rules, however, the US giant might…

To read the full story

Related Article

BUSINESS

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Tatsuya Otsuka

Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…

By Philip Carrigan

Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…