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
1 case as defendant.
Company overview. Strides Pharma Inc. (SPI) is the U.S. arm of Strides Pharma Science Limited, a public generics company incorporated in 1990 and headquartered in Bengaluru, India (NSE: STAR; BSE: 532531). SPI operates a formulations plant at 1 Ram Ridge Road, Chestnut Ridge, New York, formerly an Endo International facility that Strides acquired and expanded (~200,000 sq ft, ~250 jobs). The parent reports roughly 3,300–4,000 employees; GlobalData lists FY2025 revenue of about $557.7M and a market cap near $947M. The defendants in the tracked suits are actually named as Strides Pharma Global Pte. Ltd., Singapore — a step-down wholly owned subsidiary of Strides Pharma Science — alongside related Strides entities.
Products / operations. SPI manufactures and markets generic and specialty finished-dose pharmaceuticals: oral solids, liquids, semisolids (creams, ointments, gels), hormones, modified-release products, and DEA-registered controlled substances, with capacity for nasal sprays and drug–device combinations. The parent runs seven manufacturing sites across India, Singapore, Italy, Kenya, and the U.S. and sells into over 100 countries. SPI also does contract manufacturing for third parties.
Patent-litigation posture. Strides is a classic operating company and defendant in Hatch-Waxman/ANDA litigation — not an NPE. The case data show 0 plaintiff cases and 2 defendant cases, both filed July 31, 2026, in the U.S. District Court for the District of Delaware by Neurelis, Inc., the innovator of VALTOCO® (diazepam) nasal spray. The suits allege Strides' abbreviated new drug application for a generic diazepam nasal spray would infringe Neurelis method-of-treatment patents covering pediatric seizure-cluster use. Delaware is the customary venue for ANDA cases; no Eastern District of Texas activity appears.
Notable context. Both tracked cases carry the same caption (Neurelis, Inc. v. Strides Pharma Global PTE Ltd. et al.) and arise from a Paragraph IV certification. They align with Strides' stated push into nasal-spray and drug–device combination products: the Chestnut Ridge site passed a December 2025 FDA pre-approval inspection covering nasal-spray combinations, and Strides' Singapore subsidiary has announced nasal-spray development partnerships with Kenox Pharmaceuticals. Revenue and employee figures above are third-party estimates and not company-audited.
ANDA case against Strides over diazepam nasal spray under Strides ANDA No. 221329; coordinated with the consolidated VALTOCO ANDA actions.