The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that brand-name drug manufacturers and generic drug applicants file certain agreements with the FTC and the Department of Justice.? This page presents information related to the filing process, as well as, fiscal year reports summarizing the number and types of agreements filed.
- Pharmaceutical Agreement Filings – Overview
- Frequently Asked Questions
- MMA Pharmaceutical Agreement Filing Cover Sheet (NDAs & ANDAs)
- MMA Pharmaceutical Agreement Filing Cover Sheet (BLAs)
Advisory Opinions and Guidance
For Release: May 10, 2011: FTC Staff Finds Sanofi-Aventis, Watson Pharmaceuticals, and Synthon Holding B.V. Failed to Report Drug Patent Agreements as Required by Law: The FTC Does Not Take Enforcement Action, but Urges Industry to Closely Consider Advisory
- Letter to Helene D. Jaffe, Counsel for Sanofi-Aventis
- Letter to Joseph J. Simons and E. Anthony Figg, Counsel for Synthon Holding B.V.
- Letter to Steven C. Sunshine, Counsel for Watson Pharmaceuticals/Watson Laboratories