Hatch-Waxman, biosimilars and the patents behind approved drugs.
40 articles · page 2 of 4
When several ANDA filers seek approval for the same drug, a branded pharmaceutical company may struggle to bring Hatch-Waxman Act patent infringement lawsuits against all challengers in a single court due to venue limitations. In recent years,…
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…
Written by : Ari Feinstein & Jane Dai, Ph.D. As we previously discussed , on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device…
Written by : Ashley C. Morales & Michael L. Fuller On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to…
Written by : Ari Feinstein & Jane Dai, Ph.D. As we recently discussed , the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug…
As the relentless march of time continues, pharmaceutical executives find themselves facing the inevitability of patent expirations and the subsequent entry of generic or biosimilar competition. This reality underscores the imperative for continual…
BeiGene , a biotechnology company, has taken legal action by filing patent infringement lawsuits against pharmaceutical companies Sandoz and MSN Pharmaceuticals , along with MSN Laboratories Private Ltd. This move targets the defendants' attempts to…
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…
Corcept Therapeutics experienced a significant drop in its stock value by 27% on Tuesday following an unfavorable verdict in a patent infringement lawsuit against Teva Pharmaceutical Industries (NASDAQ:TEVA). The ruling by a US District Court stated that…
Source: https://www.greyb.com/blog/drug-patents-expiring-2024/ The pharmaceutical industry is undergoing a important phase as numerous patents for key drugs are slated to expire in 2024. This impending expiration of patents signals a significant shift in…
In late August of this year, our ANDA Intelligence 2023 Report was released, a comprehensive study, covering the Hatch-Waxman litigation within US district courts. The report focused on the period from July 1, 2018, through June 30, 2023, encapsulating a…
In a significant ruling on December 19, 2023, the German patent court invalidated a crucial patent that formed the core of CureVac's lawsuit against BioNTech, causing a notable impact on the stock market. Following Presiding Judge Walter Schramm's…
