Definition
Paragraph IV Certification is a statement in an ANDA that Orange Book-listed patents are either invalid, unenforceable, or will not be infringed by the generic product. It’s the mechanism for generic companies to seek approval before patent expiry.
How Paragraph IV Works
Generic companies file ANDAs with Paragraph IV certifications and notify brand patent holders. This often triggers patent litigation with a 30-month stay on FDA approval.
ANDA Patent Certifications
| Paragraph | Meaning | Effect |
|---|---|---|
| I | No patents listed | Immediate approval possible |
| II | Patents expired | Immediate approval possible |
| III | Will not market until expiry | Approval after patent expires |
| IV | Invalid or not infringed | Approval possible immediately |
Paragraph IV Timeline
| Event | Timing |
|---|---|
| ANDA Filed with Para IV | Day 0 |
| Notice to Patent Holder | Within 20 days of ANDA filing |
| Lawsuit Period | 45 days for brand to sue |
| 30-Month Stay (if sued) | Blocks approval unless resolved |
| Court Decision | Determines approval timing |
Why BD Teams Track Paragraph IV
For business development professionals, Paragraph IV signals competitive threats:
- Deal Implication: Paragraph IV filings indicate imminent generic competition; affects asset valuation
- Due Diligence Focus: Track Paragraph IV filings against portfolio products
- Opportunity Signal: Authorized generic or settlement partnerships often emerge from Paragraph IV situations