Hatch-Waxman, biosimilars and the patents behind approved drugs.
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An Orange Book entry is an assertion, not an adjudication — and the difference is where most ANDA disputes actually live. Three things to check first 1. Use codes. They frame the carve out fight before anyone files. 2. Expiry versus exclusivity. They are…
ANDA litigation remains one of the most demanding areas of patent law, where outcomes often hinge on the experience and judgment of individual attorneys. In disputes that determine when a generic drug can enter the market, the role of lead counsel is…
Abbreviated New Drug Application (ANDA) litigation remains one of pharma’s most contested arenas. With market exclusivity and billions in annual sales on the line, each case influences competition, pricing, and the speed at which patients see…
Over the past several years, patent litigation has gone through its share of ups and downs. Shifting legal standards, evolving strategies by patent owners and defendants, and broader economic factors have all played a role in defining the volume and nature…
In an effort to increase oversight and regulation of third-party litigation funding (TPLF), Senator Thom Tillis has introduced legislation that seeks to close tax loopholes currently benefiting domestic and foreign entities involved in funding U.S.…
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…
Shares of Intra-Cellular Therapies (NASDAQ: ITCI) increased by nearly 15% last week after the company reached a significant settlement with Sandoz in the ongoing Caplyta (lumateperone) patent litigation. The announcement , which coincides with major…
Written by : Joseph Reisman, Ph.D. & Sophia Zahn As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book , counsel for Teva and Amneal presented oral arguments in the Court of…
The competitive landscape of ANDA litigation has played a significant role in shaping the pharmaceutical industry, showcasing the legal experts who make a substantial impact in this field. Attorneys specializing in ANDA cases are pivotal in protecting the…
In the pharmaceutical industry, innovation drives progress, but intense legal battles, particularly in ANDA (Abbreviated New Drug Application) litigation, shape the competitive landscape. Our recently released 2024 ANDA Litigation Intelligence Report…
Written by : Susan M. Janicki, Ph.D. & Eric Furman, Ph.D. On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent…
As the pharmaceutical industry continues to face an ever-changing legal environment, staying informed about trends in ANDA litigation has never been more crucial. At Patexia, we are committed to providing stakeholders with the most reliable and up-to-date…
