“Authorized Generics” Windfall to consumers or new strategy to.ppt

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2018-04-22 发布于江西
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“Authorized Generics” Windfall to consumers or new strategy to.ppt

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“Authorized Generics” Windfall to consumers or new strategy to

“Authorized Generics”Windfall to consumers or new strategy to harm competition? Background on Pharmaceutical Regulation Question Does the use of AGs further then goals of Hatch-Waxman – Promote patent challenges by rewarding the first-filer with exclusivity or – Give the branded company the ability to control or diminish generic competition? Disincentive for Patent Challenges Due to Reduced Profit? ANDA Approvals and Tentative Approvals Receipts of Original ANDAs New Firms with First ANDA Approval in Last 12 Months* Aigis Industries Akyma Pharm Aurobindo Aurosal Cedar Pharm Cobalt Gedeon Richter Hikma Pharm Invagen Pharm Novex Pharm Orchid Healthcare Pharmax Group Rx Elite Spectrum Pharm Yung Shin Pharm Zydus Pharm ROI on paraIV Filing Significant Profit for ANDA filers when there is Limited Competition Background on Pharmaceutical Regulation Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. §301 et seq, governs manufacture and marketing of pharmaceuticals FDA is the primary regulatory agency for pharmaceuticals Marketing of a new drug requires filing a “New Drug Application” (NDA) with the FDA, along with clinical tests showing that the drug is both safe and effective for the intended use Approved drugs, and certain underlying patents, are listed in the “Orange Book” Background on Pharmaceutical Regulation (cont.) Hatch-Watch Act amended the FDCA to permit expedited approval process for generics Generic need only file an Abbreviated New Drug Application (ANDA) ANDA must demonstrate that the generic is “bioequivalent” to an approved NDA Generic must file certification regarding patents listed in “Orange Book” for the respective NDA (4 possible certifications) Background on Pharmaceutical Regulation (cont.) Paragraph IV Certification: patent is invalid or will not be infringed After being notified, if NDA timely files suit, 30 month “automatic stay” is triggered (FDA prohibited from approving another ANDA) First ANDA is granted a 180 day exclusivity per