efavirenz; emtricitabine; tenofovir disoproxil fumarate · Gilead Sciences · NDA 021937
Atripla
Earliest generic entry, as listed
28 Apr 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8598185.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8598185 | drug product · sets the listed date | 28 Apr 2029 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021937 · 001 · RLD · discontinued | tablet, oral | 600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 28 Apr 2029 |
Expired or delisted (4)
- US 9018192 · use U-750 · 13 Jun 2026
- US 9018192 · use U-1170 · 13 Jun 2026
- US 9545414 · product, use U-1170 · 13 Jun 2026
- US 9545414 · product, use U-750 · 13 Jun 2026