FDA Orange Book
Generic for Complera
Complera contains emtricitabine, rilpivirine 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
Yes. The generic name for Complera is emtricitabine, rilpivirine and tenofovir disoproxil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Complera and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Complera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG;EQ 25MG BASE;300MG | Marketed (Rx) | AB | 2 | AB |
NDA 202123, 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.
Approved generic emtricitabine, rilpivirine and tenofovir disoproxil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 208452 | AB (A-rated, therapeutically equivalent) | May 20, 2025 | 200MG;EQ 25MG BASE;300MG |
| LAURUS LABS LTD | 220232 | AB (A-rated, therapeutically equivalent) | March 4, 2026 | 200MG;EQ 25MG BASE;300MG |
Complera patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10857102 | January 14, 2033 | Drug product | None | 202123 |
Complera NDC codes
Questions
Is there a generic for Complera?
Yes. The generic name for Complera is emtricitabine, rilpivirine and tenofovir disoproxil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Complera?
The active ingredient in Complera is emtricitabine, rilpivirine and tenofovir disoproxil, per the FDA Orange Book.
When does the Complera patent expire?
The last patent listed for Complera in the Orange Book expires January 14, 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.
More on Complera and Emtricitabine, Rilpivirine and Tenofovir Disoproxil
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- NDC 61958-1101Complera NDC record
- Controlled substances by scheduleDEA list
- Generic drug lookupFDA Orange Book