cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate · Gilead Sciences Inc · NDA 203100
Stribild
Earliest generic entry, as listed
6 Apr 2033
Blocked by patent: US 10039718 (pediatric extension).
Listed patents · 7 unexpired
13 Orange Book listing rows for 7 patents, including 7 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10039718 | drug product | 6 Apr 2033 |
| US 10039718 listing row | drug product | 6 Oct 2032 |
| US 10039718 listing row | pediatric extension · sets the listed date | 6 Apr 2033 |
| US 8633219 | drug product, use U-257 | 30 Oct 2030 |
| US 8633219 listing row | drug product, use U-257 | 30 Apr 2030 |
| US 8633219 listing row | pediatric extension | 30 Oct 2030 |
| US 8148374 | drug substance, drug product, use U-1279 | 3 Mar 2030 |
| US 8148374 listing row | drug substance, drug product, use U-1279 | 3 Sep 2029 |
| US 8148374 listing row | pediatric extension | 3 Mar 2030 |
| US 9891239 | drug product, use U-257 | 3 Mar 2030 |
| US 9891239 listing row | drug product, use U-257 | 3 Sep 2029 |
| US 9891239 listing row | pediatric extension | 3 Mar 2030 |
| 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 | 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 | 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
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 |
|---|---|---|---|
| 203100 · 001 · RLD | tablet, oral | 150MG;150MG;200MG;300MG | 6 Apr 2033 |
Expired or delisted (1)
- US 7176220 · substance, product, use U-257 · 27 Aug 2026