Neurelis, Inc. v. Strides Pharma Global PTE Limited et al.
active- Docket:
- 1:26-cv-00947
- Filed:
- 2026-07-31
ANDA case against Strides over diazepam nasal spray under Strides ANDA No. 221329; coordinated with the consolidated VALTOCO ANDA actions.
Defendant
Strides Pharma Global PTE Limited
1 case as defendant.
- Cases
- 1
- Active
- 1
- 0 closed
- Filed
- 2026
- Top venue
- D. Delaware
- 1 case
Company profile
Company overview
Strides Pharma Global Pte. Limited (SPG) is a Singapore-incorporated company serving as the international headquarters and a step-down, wholly owned subsidiary of Strides Pharma Science Limited (formerly Strides Arcolab), a public pharmaceutical company listed on India's NSE and BSE (ticker: STAR / 532531) and headquartered in Bengaluru. SPG was awarded International Headquarters status by Singapore's EDB in 2015. Parent-company scale: roughly US$558 million revenue (FY2025, per GlobalData) and a market cap of about US$0.9–1.1 billion; the group operates manufacturing sites in India, Italy, Kenya, and the U.S.
Products / services / operations
SPG houses Strides' international business for regulated markets (U.S., Europe, Canada, Australia) and is the vehicle through which the parent files U.S. abbreviated new drug applications (ANDAs) for generic finished-dose products. Recent SPG USFDA approvals include generic celecoxib capsules, OTC acetaminophen/ibuprofen tablets, and prednisone tablets, manufactured at Strides' Indian plants. It also holds stakes in group entities (Strides Pharma, Inc. in the U.S., Strides Pharma International AG in Switzerland) and has pursued development partnerships for nasal spray products and in-licensing/procurement platforms (Amexel Pte).
Patent-litigation posture
SPG is an operating company, not an NPE. Its one tracked case is as defendant: Neurelis, Inc. v. Strides Pharma Global PTE Limited et al., filed July 31, 2026 in the District of Delaware — a routine Hatch-Waxman/ANDA suit (Nature of Suit 835) in which an innovator sues a generic entrant. Delaware is the standard venue for such cases, not an NPE-friendly forum choice.
Notable cases or context
In that suit, Neurelis — maker of Valtoco (diazepam) nasal spray — alleges that SPG and its U.S. affiliate submitted ANDA No. 221329 with Paragraph IV certifications, asserting seven patents covering benzodiazepine nasal formulations and pediatric treatment methods and seeking to delay approval. The case reflects SPG's role as the filing entity for Strides' U.S. generic pipeline, including complex nasal-dose products. No judgment or merits determination has been made.