FDA Orange Book
Is there a generic for Pifeltro?
Pifeltro contains doravirine. 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 Pifeltro (doravirine). The Orange Book shows its last listed patent expires August 30, 2032.
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Pifeltro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 210806, held by MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pifeltro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-2630 | 210806 |
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-2394 | 210806 |
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-3308 | 210806 |
Pifeltro NDC codes
Questions
Is there a generic for Pifeltro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pifeltro (doravirine). The Orange Book shows its last listed patent expires August 30, 2032.
What is the generic name for Pifeltro?
The active ingredient in Pifeltro is doravirine, per the FDA Orange Book.
When does the Pifeltro patent expire?
The last patent listed for Pifeltro in the Orange Book expires August 30, 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 Pifeltro and Doravirine
- What is Pifeltro used for?FDA label uses
- Is Pifeltro a controlled substance?Federal schedule
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- NDC 0006-3069Pifeltro NDC record
- NDC 50090-6268Pifeltro NDC record
- Controlled substances by scheduleDEA list