Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged generic drugs · clear
Revlimid (lenalidomide) , developed by Celgene Corporation, has been a groundbreaking treatment for multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma since its FDA approval in 2005. The drug has also been at the center of complex legal…
Shares of UroGen Pharma (NASDAQ: URGN) took a minor premarket hit following news that Teva Pharmaceutical (NYSE: TEVA) has submitted an application seeking FDA approval for a generic version of UroGen's bladder cancer therapy, Jelmyto. The move by Teva…
Last month, we released our third annual ANDA Litigation Intelligence Report evaluating all stakeholders in ANDA/Hatch-Waxman cases filed over the last five years, from July 1, 2017, through June 30, 2022. Previously, on Patexia 148 , we analyzed the…
This morning we released our third annual ANDA Litigation Intelligence Report. The report covers high-level statistics related to Hatch-Waxman litigation including the analysis of the outcomes, most popular district courts, filing trends and of course, the…
The FDA evaluates the generic versions of a drug and approves them only if studies show that it is bioequivalent with the brand, meaning that both drugs have the exact same amount of the active ingredient. As for size, color, shape, and other visual…
In early 1983, Bolar Pharmaceutical Inc. wanted to bring a generic version of the Dalmane drug, a sleeping pill, to the market. At that time, Roche Products Inc. held patent rights for flurazepam hydrochloride, the active ingredient in the drug.…
Janssen Pharmaceuticals, Inc. , manufacturers of the Ortho Tri-Cyclen birth control drug, are filing an injunction against Glenmark Generics, Ltd. , an Indian-based generic drug manufacturer that manufactures and sells numerous generic products within the…
