FDA Orange Book
Is there a generic for Biktarvy?
Biktarvy contains bictegravir, 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 Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide). The Orange Book shows its last listed patent expires November 8, 2036 and its last listed exclusivity ends July 30, 2032.
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Biktarvy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 30MG BASE;120MG;EQ 15MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 50MG BASE;200MG;EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210251, 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.
Biktarvy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9296769 | August 15, 2032 | Drug substance, Drug product | U-257 | 210251 |
| 8754065 | August 15, 2032 | Drug substance, Drug product | U-257 | 210251 |
| 9296769*PED | February 15, 2033 | Method of use | None | 210251 |
| 8754065*PED | February 15, 2033 | Method of use | None | 210251 |
| 9216996 | December 19, 2033 | Drug substance, Drug product | None | 210251 |
| 9732092 | December 19, 2033 | Drug substance, Drug product | None | 210251 |
| 10385067 | June 19, 2035 | Method of use | U-257 | 210251 |
| 9708342 | June 19, 2035 | Drug substance, Drug product | None | 210251 |
| 12594244 | November 8, 2036 | Drug product | U-257 | 210251 |
| 11744802 | November 8, 2036 | Drug product | None | 210251 |
| 10548846 | November 8, 2036 | Drug product | None | 210251 |
Biktarvy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-256 | Orphan drug exclusivity | June 18, 2026 | 210251 |
| I-942 | New indication | February 23, 2027 | 210251 |
| M-305 | Miscellaneous | April 24, 2027 | 210251 |
| ODE-378 | Orphan drug exclusivity | October 7, 2028 | 210251 |
| ODE-468 | Orphan drug exclusivity | February 23, 2031 | 210251 |
| ODE-540 | Orphan drug exclusivity | July 30, 2032 | 210251 |
Biktarvy NDC codes
Questions
Is there a generic for Biktarvy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide). The Orange Book shows its last listed patent expires November 8, 2036 and its last listed exclusivity ends July 30, 2032.
What is the generic name for Biktarvy?
The active ingredient in Biktarvy is bictegravir, emtricitabine and tenofovir alafenamide, per the FDA Orange Book.
When does the Biktarvy patent expire?
The last patent listed for Biktarvy in the Orange Book expires November 8, 2036. 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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