FDA Orange Book
Is there a generic for Odefsey?
Odefsey contains emtricitabine, rilpivirine 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 Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide). The Orange Book shows its last listed patent expires February 15, 2033.
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Odefsey products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG;EQ 25MG BASE;EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208351, 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.
Odefsey patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9296769 | August 15, 2032 | Drug substance, Drug product | U-257 | 208351 |
| 8754065 | August 15, 2032 | Drug substance, Drug product | U-257 | 208351 |
| 8754065*PED | February 15, 2033 | Method of use | None | 208351 |
| 9296769*PED | February 15, 2033 | Method of use | None | 208351 |
Odefsey NDC codes
Questions
Is there a generic for Odefsey?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide). The Orange Book shows its last listed patent expires February 15, 2033.
What is the generic name for Odefsey?
The active ingredient in Odefsey is emtricitabine, rilpivirine and tenofovir alafenamide, per the FDA Orange Book.
When does the Odefsey patent expire?
The last patent listed for Odefsey in the Orange Book expires February 15, 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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