Generic pharmaceutical regulation in the United States with comparison to Europe: innovation and competition.

This document cites

• US Code - 35 U.S.C. § 154 Contents and Term of Patent; Provisional Rights
• US Code - 35 U.S.C. § 271 Infringement of Patent
• Code of Federal Regulations - Definitions
• Code of Federal Regulations - Date of approval of a 505(b)(2) application or ANDA
• Code of Federal Regulations - New drug product exclusivity



See all quotations

• US Code - 21 U.S.C. § 321 Definitions; Generally
• US Code - 21 U.S.C. § 355a Pediatric Studies of Drugs
• US Code - 21 U.S.C. § 360aa Recommendations For Investigations of Drugs For Rare Diseases Or Conditions
• 2004/310/EC: Commission Decision of 26 July 2000 declaring a concentration compatible with the common market and the EEA Agreement (Case COMP/M.1806 — AstraZeneca/Novartis) — Council Regulation (EEC) No 4064/89 (notified under document number C(2000) 2309) (Text with EEA relevance)
• Federal Cases - Aaipharma Inc. v. Thompson
• Federal Cases - In re Buspirone Patent Litigation
• Federal Cases - United States v. Generix Drug Corporation
• Federal Cases - Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.
• Federal Cases - Mylan Pharmaceuticals v. U.S. Food and Drug
• Federal Cases - Watson Pharmaceuticals, Inc. v. Henney, No. 00CV3516.
• Federal Cases - In re Tamoxifen Citrate Antitrust Litigation
• Federal Cases - Mova Pharmaceutical Corp. v. Shalala
• Federal Cases - Teva Pharmaceutical Industries Ltd. v. Crawford, 05-5004.
• Federal Cases - United States v. Johnson
• Federal Cases - In re Terazosin Hydrochloride Antitrust Litigation
• Federal Cases - In re Ciprofloxacin Hydrochloride Antitrust Lit.