elvitegravir · Gilead Sciences Inc · NDA 203093
Vitekta
Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Apr 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7635704 (pediatric extension), US 8981103 (pediatric extension).
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7635704 | drug substance, drug product, use U-257 | 26 Apr 2027 |
| US 7635704 listing row | drug substance, drug product, use U-257 | 26 Oct 2026 |
| US 7635704 listing row | pediatric extension · sets the listed date | 26 Apr 2027 |
| US 8981103 | drug substance, drug product | 26 Apr 2027 |
| US 8981103 listing row | drug substance, drug product | 26 Oct 2026 |
| US 8981103 listing row | pediatric extension · sets the listed date | 26 Apr 2027 |
| US 7176220 | pediatric extension | 27 Feb 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
- Enters 12-month window basis: patent · 203093-002Listed date 26 Apr 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 203093-001Listed date 26 Apr 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203093 · 001 · RLD · discontinued | tablet, oral | 85MG | 26 Apr 2027 |
| 203093 · 002 · RLD · discontinued | tablet, oral | 150MG | 26 Apr 2027 |
Expired or delisted (1)
- US 7176220 · substance, product, use U-257 · 27 Aug 2026