Definition
180-Day Exclusivity is a period of market protection granted to the first ANDA applicant(s) who file with a Paragraph IV certification challenging Orange Book-listed patents. During this period, FDA cannot approve subsequent ANDAs for the same drug.
How 180-Day Exclusivity Works
The first generic company to file an ANDA with Paragraph IV certification becomes the “first filer” and earns 180-day exclusivity upon commercial launch, blocking other generics.
Triggering Events
180-day exclusivity begins on the earlier of:
- First commercial marketing by the first filer
- Court decision finding patent invalid or not infringed
180-Day Exclusivity Value
| Brand Sales | Est. 180-Day Value |
|---|---|
| $1 billion/year | $150-200 million |
| $5 billion/year | $500-750 million |
| $10 billion/year | $1+ billion |
Forfeiture Provisions
| Forfeiture Event | Description |
|---|---|
| Failure to Market | Not launching within certain timeframes |
| Withdrawal | Withdrawing ANDA or Paragraph IV certification |
| Amendment | Amending to different certification |
| Settlement | Certain settlement agreements |
Why BD Teams Track 180-Day Exclusivity
For business development professionals, 180-day exclusivity drives generic economics:
- Deal Implication: First-filer status dramatically increases ANDA value for licensing or acquisition
- Due Diligence Focus: Verify first-filer status and potential forfeiture risks
- Opportunity Signal: First filers may seek partners for manufacturing or marketing capacity