FDA Orange Book
Is there a generic for Stribild?
Stribild contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil). The Orange Book shows its last listed patent expires April 6, 2033.
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Stribild products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;150MG;200MG;300MG | Marketed (Rx) | None | 0 | None |
NDA 203100, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Stribild patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7176220 | August 27, 2026 | Drug substance, Drug product | U-257 | 203100 |
| 7635704 | October 26, 2026 | Drug substance, Drug product | U-257 | 203100 |
| 8981103 | October 26, 2026 | Drug substance, Drug product | None | 203100 |
| 7176220*PED | February 27, 2027 | Method of use | None | 203100 |
| 7635704*PED | April 26, 2027 | Method of use | None | 203100 |
| 8981103*PED | April 26, 2027 | Method of use | None | 203100 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-1279 | 203100 |
| 9891239 | September 3, 2029 | Drug product | U-257 | 203100 |
| 8148374*PED | March 3, 2030 | Method of use | None | 203100 |
| 9891239*PED | March 3, 2030 | Method of use | None | 203100 |
| 8633219 | April 30, 2030 | Drug product | U-257 | 203100 |
| 8633219*PED | October 30, 2030 | Method of use | None | 203100 |
| 10039718 | October 6, 2032 | Drug product | None | 203100 |
| 10039718*PED | April 6, 2033 | Method of use | None | 203100 |
Stribild NDC codes
Questions
Is there a generic for Stribild?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil). The Orange Book shows its last listed patent expires April 6, 2033.
What is the generic name for Stribild?
The active ingredient in Stribild is elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil, per the FDA Orange Book.
When does the Stribild patent expire?
The last patent listed for Stribild in the Orange Book expires April 6, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
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