When have Authorized Generics been launched – prior, during or after the 180-day exclusivity?
All of the above: • 45 of the products were granted statutory 180-day exclusivity periods8 • 36 were launched during the 180-day exclusivity period8 • 5 were launched after the 180-day exclusivity period8 • 78 of the products did not have statutory 180-day exclusivity periods8 • 10 of the products were antibiotic products not subject to Hatch-Waxman provisions8
Related Questions
- Doesn’t the marketing of Authorized Generics offer consumers benefits during the 180-day exclusivity period while preserving the value of patent challenges?
- Hasn’t legislation been recently introduced to prohibit Authorized Generics during the 180-day exclusivity period?
- Are Authorized Generics only offered by brand companies with generic subsidiaries?
