Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged hatch-waxman · clear
When it comes to preparing an Abbreviated New Drug Application (ANDA), there are several common pitfalls that applicants often encounter. These pitfalls can significantly impact the approval process and delay the launch of a generic drug in the market.…
The Abbreviated New Drug Application (ANDA) process plays a vital role in the pharmaceutical industry, enabling generic drug manufacturers to bring affordable alternatives to market while respecting patent owner rights. Balancing the interests of patent…
The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, revolutionized the pharmaceutical industry by balancing the interests of brand-name drug manufacturers and generic drug manufacturers. It introduced the…
Most of the community involved in life science litigation and pharmaceutical companies, thought they saw the end of the long-fought battle between Amgen and Sanofi in 2021 with the CAFC decision . As a result, at the time, it was said that the attorney…
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…
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…
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.…
Small molecule drugs have been the norm for much of medicine’s history. Only in the past decade has there been a rise in large molecule drugs which also obtained FDA approval. When it comes to the world of pharmaceuticals, they are divided into two…
Earlier in August, we released our second ANDA Litigation Intelligence Report. We analyzed all parties involved in Hatch-Waxman cases and ranked the top law firms and attorneys based on their activity and performance. Today we will shed some light on the…
In late August, we released our second annual ANDA Litigation Intelligence Report where we evaluated all stakeholders in Hatch-Waxman cases including ANDA attorneys, local counsel, law firms, pharmaceutical companies, and judges. Today’s insight will…
