FDA Orange Book
Is there a generic for Prezcobix?
Prezcobix contains darunavir ethanolate and cobicistat. 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 Prezcobix (darunavir ethanolate and cobicistat). The Orange Book shows its last listed patent expires October 6, 2032.
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Prezcobix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;EQ 675MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG;EQ 800MG BASE | Marketed (Rx) | None | 0 | None |
NDA 205395, 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.
Prezcobix patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7700645 | December 26, 2026 | Drug substance, Drug product | None | 205395 |
| 7700645*PED | June 26, 2027 | Method of use | None | 205395 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-4162 | 205395 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-1279 | 205395 |
| 8148374 | September 3, 2029 | Drug substance, Drug product | U-2939 | 205395 |
| 10039718 | October 6, 2032 | Drug product | None | 205395 |
Prezcobix NDC codes
Questions
Is there a generic for Prezcobix?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prezcobix (darunavir ethanolate and cobicistat). The Orange Book shows its last listed patent expires October 6, 2032.
What is the generic name for Prezcobix?
The active ingredient in Prezcobix is darunavir ethanolate and cobicistat, per the FDA Orange Book.
When does the Prezcobix patent expire?
The last patent listed for Prezcobix in the Orange Book expires October 6, 2032. 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 Prezcobix and Darunavir Ethanolate and Cobicistat
- What is Prezcobix used for?FDA label uses
- Is Prezcobix a controlled substance?Federal schedule
- Generic for Prezcobix PedFDA Orange Book
- Cytochrome P450 3A Inhibitors listFDA drug class
- Protease Inhibitors listFDA drug class
- Prezcobix Medicare Part D coverageBy plan and state
- NDC 50090-1723Prezcobix NDC record
- NDC 59676-575Prezcobix NDC record
- NDC 59676-578Prezcobix NDC record