FDA Orange Book
Is there a generic for Idvynso?
Idvynso contains doravirine and islatravir. 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 Idvynso (doravirine and islatravir). The Orange Book shows its last listed patent expires August 30, 2032 and its last listed exclusivity ends April 20, 2031.
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Idvynso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG;0.25MG | Marketed (Rx) | None | 0 | None |
NDA 216964, held by MERCK SHARP AND DOHME LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Idvynso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7339053 | May 31, 2027 | Drug substance | None | 216964 |
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-4527 | 216964 |
Idvynso exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 20, 2031 | 216964 |
Idvynso NDC codes
Questions
Is there a generic for Idvynso?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Idvynso (doravirine and islatravir). The Orange Book shows its last listed patent expires August 30, 2032 and its last listed exclusivity ends April 20, 2031.
What is the generic name for Idvynso?
The active ingredient in Idvynso is doravirine and islatravir, per the FDA Orange Book.
When does the Idvynso patent expire?
The last patent listed for Idvynso 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.