darunavir · Janssen Prods · NDA 021976, 202895
Prezista
Earliest generic entry, as listed · earliest of 5 marketed strengths
26 Jun 2027
Blocked by patent: US 7700645 (pediatric extension).
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7700645 | drug substance, drug product | 26 Jun 2027 |
| US 7700645 listing row | drug substance, drug product | 26 Dec 2026 |
| US 7700645 listing row | pediatric extension · sets the listed date | 26 Jun 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 24 Oct 2026Enters 12-month window basis: patent · 021976-00626 Jun 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021976-00226 Jun 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021976-00326 Jun 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021976-00126 Jun 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021976-00526 Jun 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021976-00426 Jun 2027
- 24 Oct 2026Enters 12-month window basis: patent · 202895-00126 Jun 2027
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021976 · 001 · RLD · discontinued | tablet, oral | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Jun 2027 |
| 021976 · 002 · RLD | tablet, oral | 600MG | 26 Jun 2027 |
| 021976 · 003 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Jun 2027 |
| 021976 · 004 · RLD | tablet, oral | 75MG | 26 Jun 2027 |
| 021976 · 005 · RLD | tablet, oral | 150MG | 26 Jun 2027 |
| 021976 · 006 · RLD | tablet, oral | 800MG | 26 Jun 2027 |
| 202895 · 001 · RLD | suspension, oral | 100MG/ML | 26 Jun 2027 |