62 articles · page 4 of 6
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market entry of generic drugs. However, the intersection of patents and generic drug approvals can be a complex and challenging…
Written by : Blake A. Winn & Jason J. Jardine The “Orange Book”, more formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, identifies U.S. Food and Drug Administration (FDA) approved drug products as well as any…
Written by : Nima Zargari, Ph.D. On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC , the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an…
In late August, we published our third annual ANDA Litigation Intelligence Report. We evaluated the stakeholders for Hatch-Waxman cases filed between July 1, 2017, and June 30, 2022. This report's major highlights have been covered in our previous…
In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in Hatch-Waxman litigation, including attorneys, local counsel, law firms, generic and brand pharmaceutical…
Last August, we published our third annual ANDA Litigation Intelligence Report. The report covered the ANDA litigation landscape and focused on cases filed during the past five years. We provided different statistics related to the Hatch-Waxman litigation…
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…
Two days ago, the companies that joined forces in order to develop the first Covid vaccine that got approval for emergency use by FDA, Pfizer and BioNTech received news of yet another lawsuit related to the mRNA technology used to develop the vaccine.…
Less than two months ago, Curevac filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech over patent infringement alleging that BioNTech’s Covid-19 vaccine infringed its patents related to mRNA technology. With their…
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.…
