FDA Orange Book · active-ingredient family
Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:STRIBILD · NDA 203100
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STRIBILDRLD | GILEAD SCIENCES INC | NDA 203100 | — | Aug 27, 2012 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7176220 | Aug 27, 2026 | in 2 mo | SubstanceProductU-257 |
| 7635704 | Oct 26, 2026 | in 4 mo | SubstanceProductU-257 |
| 8981103 | Oct 26, 2026 | in 4 mo | SubstanceProduct |
| 7176220*PED | Feb 27, 2027 | in 8 mo | |
| 7635704*PED | Apr 26, 2027 | in 10 mo | |
| 8981103*PED | Apr 26, 2027 | in 10 mo | |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-1279 |
| 9891239 | Sep 03, 2029 | in 3 yr 3 mo | ProductU-257 |
| 8148374*PED | Mar 03, 2030 | in 3 yr 9 mo | |
| 9891239*PED | Mar 03, 2030 | in 3 yr 9 mo | |
| 8633219 | Apr 30, 2030 | in 3 yr 11 mo | ProductU-257 |
| 8633219*PED | Oct 30, 2030 | in 4 yr 5 mo | |
| 10039718 | Oct 06, 2032 | in 6 yr 5 mo | Product |
| 10039718*PED | Apr 06, 2033 | in 6 yr 11 mo |
Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
