ANDA
1. Permit a company to place its FDA-approved BIOEQUIVALENT drug on the market as soon as the composition of matter patent on the brand name drug expires
2. No safety or efficacy data required except bioequivalence study
3. Must copy branded drug package insert
Hatch - Waxman Patent Term & Restoration of 1984
1. Provides additional period of patent protection to branded drugs to compensate for loss of patent life due to regulatory review & approval
2. Generic manufacturers allowed to begin development work, submit applications and receive tentative approval prior to brand patent expiration which allows generic manufacturers to launch as soon as possible.
Types of Additional Exclusivity
1. Hatch-Waxman - Patent extension for branded
New chemical entity - 5 years
New use - 3 years
2. Orphan drug exclusivity - 7 years
3. Pediatric exclusivity - 180 days added to existing patent or exclusivity
For generics, 1st to file ANDA & challenge patents - 180 days marketing exclusivity
Strategy for Generic
Challenge validity of brand patent as early as possible
Conduct product development for regulatory approval 6-7 years prior to patent expiration
Challenge innovator’s patent, file ANDA & paragraph IV to set patent challenge in motion. Notify innovator who will sue and get 180 days of exclusivity by being the 1st to file.
Start process moving for litigation - If generic manufacturer wins, the company is granted 6 months market exclusivity following patent expiry.
]Conduct product development for regulatory approval 6-7 years prior to patent expiration
]Challenge innovator’s patent, file ANDA & paragraph IV to set patent challenge in motion. Notify innovator who will sue and get 180 days of exclusivity by being the 1st to file.
]Start process moving for litigation - If generic manufacturer wins, the company is granted 6 months market exclusivity following patent expiry.
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