Part of Sandoz International GmbH
Clinical Trials
4
0 active
Approvals
444
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
Completed
2
50.0%
Recruiting
1
25.0%
- Nevada Attorney General Aaron Ford and a coalition of 43 states announced a $400 million settlement in principle with Sandoz Inc. over allegations of widespread generic drug price manipulation. - The settlement resolves claims that Sandoz and its international affiliates engaged in long-running conspiracies to artificially inflate prices and reduce competition on numerous generic prescription drugs. - Sandoz has agreed to injunctive terms including internal reforms to ensure fair competition and compliance with antitrust laws, with a trial anticipated in 2027. - The broader multistate antitrust litigation, ongoing since 2016, has now secured settlements totaling approximately $565.5 million across multiple generic drug manufacturers.
- The Federal Circuit reversed a $39 million jury verdict against Sandoz, finding Duke University and Allergan's patent for eyelash hair loss treatment invalid for lack of adequate written description. - The court determined that the patent's specification was too broad, encompassing billions of compounds while claiming only 1,620, failing to provide sufficient guidance to skilled artisans. - Sandoz successfully challenged the validity of claim 30 of U.S. Patent No. 9,579,270, which covers prostaglandin formulations for treating hair loss including Allergan's FDA-approved Latisse. - The decision establishes important precedent for patent validity requirements, particularly regarding written description standards for chemical compound patents with broad specifications.
- The Federal Circuit reversed a $39 million jury verdict against Sandoz, finding Duke University and Allergan's hair loss patent invalid for lacking adequate written description support. - The court ruled that the patent specification failed to provide sufficient "blaze marks" to guide skilled artisans from billions of disclosed compounds to the narrow subgenus of 1,620-4,230 compounds actually claimed. - The decision highlights critical requirements for chemical genus patents, emphasizing that specifications must clearly direct artisans to claimed inventions rather than presenting "maze-like paths" with multiple branching options. - The ruling affects LATISSE, Allergan's eyelash growth drug containing prostaglandin F analogs, and establishes important precedent for written description requirements in pharmaceutical patents.
• Caplin Steriles has received FDA approval for its generic version of difluprednate ophthalmic emulsion, 0.05%, a therapeutic equivalent to DUREZOL. • The approval allows Caplin Steriles to market a more affordable alternative for treating inflammation and pain associated with ocular surgery. • This generic medication mirrors Sandoz Inc.'s DUREZOL, offering similar efficacy and safety profiles for patients requiring corticosteroid treatment in the eye. • The FDA's decision underscores Caplin Steriles' commitment to providing accessible and cost-effective pharmaceutical options in the ophthalmology space.
