In a compelling appeal to regulatory authorities, a Health Activist Nadie Jauhri has urged regulatory probe into overcharging of MSD’s diabetic drug, supply chain inconsistencies and product labeling discrepancies.
Ami successful filing of the USDMF for Sitagliptin Phosphate Monohydrate
CAMBRIDGE, Mass., Jan. 18, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive pre-clinical safety data of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in combination with sitagliptin, a DPP4 inhibitor. Additionally, having satisfied its 45-day commitment with the U.S. Food and Drug Administration (FDA) related to its amended protocol, the company has opened enrollment for Part 2 of its Phase 2a clinical trial of DA-1241 when co-administered with sitagliptin for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.
The dispute between Merck and Viatris over the patent rights for blockbuster diabetes drugs Januvia and Janumet is over — so long as a judge signs off.
Sitagliptin, an anti-diabetic drug, sold under the brand name Januvia and is used to treat Type 2 diabetes. In July this year, the drug lost its patent. Usually, loss of patent means a fall in the price of the drug, and according to industry experts, sometimes by more than 50-70 per cent.
Merck, known as MSD outside of the United States and Canada, announced that the US Court of Appeals for the Federal Circuit ruled in favour of the company in a patent challenge brought by Mylan Pharmaceuticals, Inc. (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride extended-release).
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Court of Appeals for the Federal Circuit ruled in favor of the company in a patent challenge brought by Mylan Pharmaceuticals, Inc. (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in JANUVIA® (sitagliptin), JANUMET® (sitagliptin and metformin hydrochloride) and JANUMET® XR (sitagliptin and metformin hydrochloride extended-release).
New Delhi, Sep 16 (PTI) The government on Friday launched diabetes drug Sitagliptin and its combinations at rates as low as Rs 60 per pack of ten, which will be sold at generic pharmacy stores, Janaushadhi Kendras.
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. District Court for the Northern District of West Virginia ruled in favor of the company in a patent infringement suit against Viatris related to sitagliptin, an active ingredient in JANUVIA, JANUMET and JANUMET XR. The Court found that both Merck patents at issue were valid and infringed. The decision is subject to appeal.