Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged drug · clear
In a significant development for the central nervous system (CNS) therapeutics market, Axsome Therapeutics, Inc. (NASDAQ: AXSM) has reached a settlement agreement with Hetero Labs Ltd. over patent litigation concerning SUNOSI® (solriamfetol)—a…
Moderna recently registered a significant triumph in its ongoing patent dispute concerning its Covid-19 vaccine against Pfizer and BioNTech. The European Patent Office (EPO) upheld the legitimacy of a key Moderna patent in an oral verdict, boosting the…
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…
In a groundbreaking legal development, Eli Lilly has secured a remarkable victory in a high-stakes patent battle that has sent shockwaves through the migraine drug market. The verdict, delivered by a Massachusetts federal judge, overturns a staggering…
When it comes to generic medications, the Abbreviated New Drug Application (ANDA) process plays a crucial role in bringing affordable alternatives to brand-name drugs to the market. At the heart of ANDA approval lies the significance of bioequivalence…
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…
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…
