Production of Generic Drug
Generic drugs can be produced:
1. When the patent is expired.
2. When the patent is affirmed as invalid and bogus.
3. In a state or territory where there is no law to protect law.
4. When no patent has been granted to any company for a certain drug.
How does a generic drug get approval?
The patents are issued by FDA. Once the patent gets expired FDA reviews the drug and allows the manufacturing of the generic drug under the Drug Price Competition and Patent Term Restoration Act of 1984.
Monday, August 24, 2009
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