Aren Authorized Generics an effort by large pharmaceutical companies and their partners to circumvent the intent of the Hatch-Waxman Act which created the 180-day exclusivity period for the first generic drug approvals?
No. The intent of Hatch-Waxman was to promote competition and allow low cost generic drugs to reach the marketplace. There is nothing in Hatch-Waxman to suggest that Authorized Generics are against public policy. In addition, Hatch-Waxman always contemplated more than one generic company during the exclusivity period. The original statute gave preference to the first to file, but Congress, in 2003, specifically provided for multiple ANDA filers on the same day to share the 180-day exclusivity. The presence of a second generic competitor in the 180- day exclusivity period is good for consumers and was clearly contemplated by Congress.
Related Questions
- With multi-national pharmaceutical companies (MNCs) looking more and more into large emerging markets as a promising source of growth, how important is Mexico in Roche’s expansion plans?
- Won’t generic companies stop challenging brand drug patents if Authorized Generics are allowed to continue?
- Are Authorized Generics only offered by brand companies with generic subsidiaries?
