No. 24A1149
Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al.
Tags: fdca-drug-definition generic-drug-approval hatch-waxman-amendments orange-book paragraph-iv-certification patent-listing
Key Terms:
Patent
Patent
Latest Conference:
N/A
Question Presented (AI Summary)
Whether the Federal Circuit properly interpreted the statutory definition of 'drug' under 21 U.S.C. § 321(g)(1)(D) and the Orange Book listing requirements under 21 U.S.C. § 355(b)(1)(A)(viii) in determining which patents must be submitted for listing in the FDA's Orange Book
Question Presented (OCR Extract)
No question identified. :
Docket Entries
2025-05-29
Application (24A1149) granted by The Chief Justice extending the time to file until July 31, 2025.
2025-05-22
Application (24A1149) to extend the time to file a petition for a writ of certiorari from June 1, 2025 to July 31, 2025, submitted to The Chief Justice.
Attorneys
Teva Branded Pharmaceutical Products R&D LLC, Norton (Waterford) Ltd., and Teva Pharmaceuticals USA, Inc.
William McGinley Jay — Goodwin Procter, LLP, Petitioner