FDA Orange Book
Is there a generic for Genvoya?
Genvoya contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. 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 Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide). The Orange Book shows its last listed patent expires April 6, 2033.
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Genvoya products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;150MG;200MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 207561, 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.
Genvoya patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7176220 | August 27, 2026 | Drug substance, Drug product | U-257 | 207561 |
| 7635704 | October 26, 2026 | Drug substance, Drug product | U-257 | 207561 |
| 8981103 | October 26, 2026 | Drug substance, Drug product | None | 207561 |
| 7176220*PED | February 27, 2027 | Method of use | None | 207561 |
| 8981103*PED | April 26, 2027 | Method of use | None | 207561 |
| 7635704*PED | April 26, 2027 | Method of use | None | 207561 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-1279 | 207561 |
| 9891239 | September 3, 2029 | Drug product | U-257 | 207561 |
| 9891239*PED | March 3, 2030 | Method of use | None | 207561 |
| 8148374*PED | March 3, 2030 | Method of use | None | 207561 |
| 8633219 | April 30, 2030 | Drug product | U-257 | 207561 |
| 8633219*PED | October 30, 2030 | Method of use | None | 207561 |
| 8754065 | August 15, 2032 | Drug substance, Drug product | U-257 | 207561 |
| 9296769 | August 15, 2032 | Drug substance, Drug product | U-257 | 207561 |
| 10039718 | October 6, 2032 | Drug product | None | 207561 |
| 8754065*PED | February 15, 2033 | Method of use | None | 207561 |
| 9296769*PED | February 15, 2033 | Method of use | None | 207561 |
| 10039718*PED | April 6, 2033 | Method of use | None | 207561 |
Genvoya NDC codes
Questions
Is there a generic for Genvoya?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide). The Orange Book shows its last listed patent expires April 6, 2033.
What is the generic name for Genvoya?
The active ingredient in Genvoya is elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, per the FDA Orange Book.
When does the Genvoya patent expire?
The last patent listed for Genvoya 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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