Five years of exclusivity is provided for drugs which do not contain active molecules that have appeared in previously-approved drugs.
This is one of the longest exclusivity terms provided by the FDA. Only
orphan drugs
receive a longer term of exclusivity, although the five years granted under the
Generating Antibiotic Incentives Now
(GAIN) Act may be added in addition to other exclusivities, giving it an effetively longer span.
This chart shows the companies which have received the most new chemical entity exclusivities in the past five years.
The companies with the most orphan drug approvals are:
- Wellstat Therap
- Actelion
- Alkermes Inc
- Allergan
- Allergan Holdings
- Amgen Inc
- Astellas
- Astrazeneca
- Bristol-myers Squibb
- Chiesi
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