FDA Orange Book
Is there a generic for Symtuza?
Symtuza contains darunavir, 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 Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide). The Orange Book shows its last listed patent expires July 19, 2038.
Run it in Rivvi
Map Symtuza 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.
Symtuza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;800MG;200MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210455, held by JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Symtuza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7700645 | December 26, 2026 | Drug substance, Drug product | None | 210455 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2353 | 210455 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2767 | 210455 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2768 | 210455 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2766 | 210455 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2364 | 210455 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2365 | 210455 |
| 8754065 | August 15, 2032 | Drug substance, Drug product | U-2352 | 210455 |
| 9296769 | August 15, 2032 | Drug substance, Drug product | U-2352 | 210455 |
| 8754065 | August 15, 2032 | Drug substance, Drug product | U-2765 | 210455 |
| 9296769 | August 15, 2032 | Drug substance, Drug product | U-2765 | 210455 |
| 10039718 | October 6, 2032 | Drug product | None | 210455 |
| 10786518 | July 19, 2038 | Method of use | U-2978 | 210455 |
Symtuza NDC codes
Questions
Is there a generic for Symtuza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide). The Orange Book shows its last listed patent expires July 19, 2038.
What is the generic name for Symtuza?
The active ingredient in Symtuza is darunavir, cobicistat, emtricitabine and tenofovir alafenamide, per the FDA Orange Book.
When does the Symtuza patent expire?
The last patent listed for Symtuza in the Orange Book expires July 19, 2038. 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 Symtuza and Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide
- What is Symtuza used for?FDA label uses
- Is Symtuza a controlled substance?Federal schedule
- Cytochrome P450 3A Inhibitors listFDA drug class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Protease Inhibitors listFDA drug class
- Symtuza Medicare Part D coverageBy plan and state
- NDC 59676-800Symtuza NDC record