Prescription medicine
Ensifentrine Brand names: Ohtuvayre
Ensifentrine (Ohtuvayre) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ensifentrine FDA label on DailyMed (effective April 23, 2026, MERCK SHARP & DOHME LLC); the NDA 217389 record on Drugs@FDA; every ensifentrine label on DailyMed.
Highlights of the record
FDA label of April 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
Forms and strengths
- 3 mg/2.5ml
Suspension.
On the market
- Earliest approval on file
- June 26, 2024 Ohtuvayre, Msd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 25, 2044 Ohtuvayre suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,505 through July 30, 2026
What is ensifentrine used for?
From the label: indications and usageOHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
Conditions named in the indications of ensifentrine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Phosphodiesterase 3 Inhibitor and Phosphodiesterase 4 Inhibitor.
Source: FDA drug label (Ohtuvayre), NDA217389 (Msd), as published by MERCK SHARP & DOHME LLC, effective April 23, 2026 (SPL set e6433c98-41a0-4f99-8f7f-d0e9db6e3f40), via openFDA; the full label on DailyMed
Is there a generic for ensifentrine (Ohtuvayre)?
No generic ensifentrine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Ohtuvayre suspension: the compound patent runs to August 21, 2031, and the last listed entry to June 25, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2044 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ensifentrine?
The FDA Adverse Event Reporting System holds 1,505 reports that list ensifentrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 61 are coded as a death and 294 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ensifentrine?
15 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as ensifentrine or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Ipratropium | COPD | 13 labelers | $0.111 per mL 0.02% solution | No current entry |
| Arformoterol | COPD | 15 labelers | $0.633 per mL 15 mcg/2 mL solution | No current entry |
| Formoterol | COPD | 11 labelers | $1.30 per mL 20 mcg/2 mL neb vial | No current entry |
| Fluticasone and vilanterol | COPD | none listed | $3.90 per unit 100-25 | No current entry |
| Budesonide and formoterol and glycopyrrolate | COPD | none listed | $61.41 per gram 160-9-4.8 mcg | No current entry |
| Fluticasone and umeclidinium and vilanterol | COPD | none listed | $11.12 per unit 100-62.5-25 | No current entry |
| Tiotropium | COPD | none listed | $126.08 per gram 1.25 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as ensifentrine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ensifentrine
- 15 medicines for the same use
- Other phosphodiesterase 3 inhibitors
- the pharmacologic class, with prices and generics
- Ensifentrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other