相关临床试验
175
6 进行中
药物批准
476
批准总数
监管机构
2
监管机构数
成立时间
N/A
进行中（未招募）
2
1.1%
已完成
164
93.7%
尚未招募
4
2.3%
招募中
3
1.7%
终止
2
1.1%
- The U.S. Court of Appeals for the Federal Circuit affirmed that Mylan's generic hypertension drug does not infringe Actelion's patents for Veletri, focusing on pH measurement standards in pharmaceutical formulations. - The court upheld the district court's construction requiring pH measurements at standard temperature rather than refrigerated conditions, finding Mylan's bulk solution pH well below the required 12.98 threshold. - Actelion was barred from asserting infringement under the doctrine of equivalents due to prosecution history estoppel and the disclosure-dedication rule following claim amendments during patent prosecution.
- The Federal Circuit held that Bayer's patent claims for rivaroxaban and aspirin combination therapy were unpatentable despite including "clinically proven effective" language, ruling this limitation was functionally unrelated to the actual treatment method. - The court applied the functional relationship test from King Pharmaceuticals, determining that clinical validation does not transform an otherwise anticipated method when specific dosages are already disclosed in prior art. - This decision addresses concerns about patent "clawback" strategies where companies attempt to extend protection over known methods by adding post-hoc validation requirements that don't change how the treatment actually works.
- The District of Delaware dismissed Novo Nordisk's patent infringement claim against Mylan's generic Wegovy application, ruling that method-of-treatment claims must align precisely with FDA-approved drug labels. - The court found that Mylan's proposed generic label did not instruct physicians to avoid all therapeutic agents when prescribing semaglutide, contradicting Novo's patent claim requiring administration "without another therapeutic agent." - The decision underscores the critical importance for pharmaceutical companies to ensure patent claim limitations match approved drug labeling, as prosecution amendments can later limit enforceability in generic drug disputes.
- A federal district court in Delaware ruled that Viatris' generic version of Wegovy does not infringe on Novo Nordisk's patent for the GLP-1 receptor agonist semaglutide. - The court determined that Viatris' product label does not encourage use without other therapeutic agents, which was a key limitation in Novo Nordisk's patent claim. - This victory removes one patent obstacle for Viatris' generic Wegovy, which is currently awaiting FDA approval, while the global Wegovy market reached $8.4 billion in 2024. - The ruling comes amid ongoing patent disputes in the lucrative obesity drug market, with GlobalData forecasting the obesity market to exceed $173.5 billion by 2031.
- Bausch Health Companies Inc. and Mylan Pharmaceuticals have reached a settlement agreement resolving their patent litigation over generic versions of irritable bowel syndrome (IBS) medications. - The settlement likely includes licensing terms allowing Mylan to market generic versions of Bausch's IBS drugs after specific dates, though exact terms remain confidential. - This agreement represents a significant development in the gastrointestinal pharmaceutical market, potentially increasing future access to affordable IBS treatments.
- Heron Therapeutics has reached a settlement agreement with Mylan Pharmaceuticals to resolve ongoing patent litigations related to CINVANTI and APONVIE injectable emulsions. - Under the settlement terms, Heron grants Mylan a license to market generic versions of both aprepitant products in the United States beginning June 1, 2032, approximately three years before patent expiration. - The agreement concludes litigation initiated by Heron in response to Mylan's abbreviated new drug applications seeking FDA approval for generic versions prior to the 2035 patent expiration.
- The FDA approved 25 first-time generic drugs in the first six months of 2025, including generics for critical medications treating HIV, cancer, and neurological conditions. - Notable approvals include generic versions of Xarelto (rivaroxaban) for blood clot prevention, Complera for HIV treatment, and Fycompa (perampanel) for seizure management. - These generic approvals span diverse therapeutic areas from oncology to ophthalmology, potentially reducing healthcare costs while maintaining equivalent clinical benefits to brand-name products.
- The Federal Circuit affirmed a preliminary injunction against Samsung Bioepis, preventing the sale of its biosimilar version of Regeneron's EYLEA (aflibercept) in the United States. - The court established that filing an abbreviated Biologics License Application with plans for nationwide distribution creates sufficient "minimum contacts" for personal jurisdiction in any U.S. state. - Samsung Bioepis failed to raise substantial questions about the validity of Regeneron's '865 patent, with the court clarifying that patent domination alone does not render a later patent obvious.
- Glenmark Pharmaceuticals Inc., USA has introduced Clindamycin Phosphate Foam 1%, a bioequivalent generic version of Evoclin® Foam, expanding their dermatology portfolio. - The reference product Evoclin® Foam achieved annual sales of approximately $5.8 million in the 12-month period ending December 2024, indicating significant market potential. - The launch strengthens Glenmark's position in the dermatology segment, with the company maintaining presence across Branded, Generics, and OTC segments globally.
