FDA Orange Book
Is there a generic for Ohtuvayre?
Ohtuvayre contains ensifentrine. 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 Ohtuvayre (ensifentrine). The Orange Book shows its last listed patent expires June 25, 2044 and its last listed exclusivity ends June 26, 2029.
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Ohtuvayre products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, inhalation | 3MG/2.5ML | Marketed (Rx) | None | 0 | None |
NDA 217389, 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.
Ohtuvayre patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9062047 | August 21, 2031 | Drug substance | U-3962 | 217389 |
| 9956171 | September 15, 2035 | Drug product | U-3962 | 217389 |
| 10945950 | September 15, 2035 | Drug product | None | 217389 |
| 12409180 | February 20, 2043 | Drug product | None | 217389 |
| 12251384 | June 25, 2044 | Drug product | None | 217389 |
Ohtuvayre exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 26, 2029 | 217389 |
Ohtuvayre NDC codes
Questions
Is there a generic for Ohtuvayre?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ohtuvayre (ensifentrine). The Orange Book shows its last listed patent expires June 25, 2044 and its last listed exclusivity ends June 26, 2029.
What is the generic name for Ohtuvayre?
The active ingredient in Ohtuvayre is ensifentrine, per the FDA Orange Book.
When does the Ohtuvayre patent expire?
The last patent listed for Ohtuvayre in the Orange Book expires June 25, 2044. 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.