Regeneron Pharmaceuticals, Inc. v. Sandoz Inc.
Ongoing- Docket:
- 1:24-cv-00085
Regeneron initiated litigation against Sandoz concerning US Patent 11084865. The case is ongoing, following the approval of Sandoz's biosimilar in August 2024.
Defendant
1 case as defendant.
Sandoz Inc. is the U.S. subsidiary of Sandoz Group AG, a global leader in generic and biosimilar medicines. Sandoz Group AG, with its headquarters in Basel, Switzerland, was founded in 1886 and spun off from Novartis as an independent publicly traded company on the SIX Swiss Exchange (ticker: SDZ) in October 2023. As of 2024, Sandoz Group AG reported revenues of approximately US$10.4 billion and employed around 23,000 people globally, with a market capitalization of roughly US$37.5 billion as of May 2026.
The company's core operations involve the development, manufacturing, and marketing of a broad portfolio of generic small molecules, complex injectables, and biosimilar medicines. These products span major therapeutic areas, including antibiotics, treatments for central nervous system disorders, gastrointestinal conditions, cardiovascular diseases, and hormone therapies. Sandoz is recognized for its role in pioneering access to affordable, high-quality medicines globally.
Sandoz Inc. operates as an operating company that routinely defends against patent infringement claims. Its litigation posture is characterized by its role as a defendant, frequently involved in disputes brought by branded pharmaceutical companies seeking to protect their patented products against Sandoz's generic or biosimilar market entries. The provided case data confirms this, showing 0 cases as a plaintiff and 1 case as a defendant.
A notable tracked case is Regeneron Pharmaceuticals, Inc. v. Sandoz Inc., filed in the U.S. District Court for the Northern District of West Virginia, which pertained to Sandoz's aflibercept biosimilar. This Biologics Price Competition and Innovation Act (BPCIA) litigation was resolved in September 2025, allowing Sandoz to enter the U.S. market with its biosimilar version of Eylea® (Enzeevu™) in the fourth quarter of 2026. Sandoz has also been involved in other significant patent disputes, such as overturning a $39 million jury verdict in Duke University v. Sandoz Inc. concerning a generic version of Latisse®, and the dismissal of Pfizer, Inc. v. Sandoz, Inc. regarding the cancer drug Inlyta®.
Regeneron initiated litigation against Sandoz concerning US Patent 11084865. The case is ongoing, following the approval of Sandoz's biosimilar in August 2024.