Comprehensive medication guide to Ohtuvayre including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
With commercial insurance and the Verona Pathway Plus copay card, eligible patients may pay as little as $0 per month. Medicare Part B + Medigap supplemental coverage may cover 100% of costs. Medicare Part D has a $2,000 annual out-of-pocket cap as of 2025. Most plans require prior authorization before covering Ohtuvayre.
Estimated Cash Pricing
Ohtuvayre has a list price of approximately $2,950 per month ($35,400 per year) without insurance. No generic version is available. Retail discount programs like GoodRx do not apply since Ohtuvayre is dispensed exclusively through specialty pharmacies.
Medfinder Findability Score
45/100
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Ohtuvayre (ensifentrine) is a prescription inhaled medication used for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Developed by Verona Pharma, it received FDA approval on June 26, 2024, making it the first inhaled COPD maintenance drug with a novel mechanism of action in more than 20 years.
Ohtuvayre is a first-in-class selective dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes. It is delivered as an inhalation suspension (3 mg/2.5 mL) via a standard jet nebulizer, taken twice daily — once in the morning and once in the evening. COPD is a group of chronic lung diseases — including emphysema and chronic bronchitis — that affects more than 8.6 million Americans receiving chronic treatment.
Ohtuvayre is not a rescue medication. Patients must continue to use their short-acting bronchodilator (such as albuterol) for acute breathing episodes. It is available only through Verona Pharma's authorized specialty pharmacy network and is not stocked at standard retail pharmacies.
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Ohtuvayre works by simultaneously blocking two enzyme pathways — PDE3 and PDE4 — that play key roles in COPD lung dysfunction. PDE3 is found in airway smooth muscle cells; inhibiting it allows cyclic AMP (cAMP) to accumulate, which causes the muscles surrounding the airways to relax. This produces bronchodilation — widening of the airway — making it easier to breathe.
PDE4 is found in immune cells that drive airway inflammation, including neutrophils, macrophages, and T-cells. By inhibiting PDE4, Ohtuvayre allows cAMP to accumulate in these cells, suppressing their inflammatory activity and reducing lung inflammation — without the use of steroids. This dual bronchodilator and non-steroidal anti-inflammatory action in one molecule is what makes Ohtuvayre mechanistically unique compared to all previously approved COPD therapies.
In the Phase 3 ENHANCE trials (1,553 patients with moderate to severe COPD), Ohtuvayre demonstrated statistically significant improvements in FEV1 (forced expiratory volume) compared to placebo, with benefits seen both as monotherapy and as add-on to LABA or LAMA therapy. Mean trough FEV1 improvement at Week 12 was 35 mL greater than placebo. The 2025 GOLD COPD guidelines acknowledge Ohtuvayre as a potential add-on therapy for patients with persistent dyspnea on two long-acting bronchodilators.
3 mg/2.5 mL — Inhalation suspension (nebulizer solution)
Unit-dose ampule; inhale twice daily (morning and evening) via standard jet nebulizer. Shake vigorously before use.
Ohtuvayre is not available at standard retail pharmacies. It is exclusively distributed through Verona Pharma's authorized specialty pharmacy network, which patients must access through the Verona Pathway Plus enrollment program. This specialty pharmacy model, combined with prior authorization requirements from virtually all major insurance plans and a list price of approximately $2,950 per month, means that many patients experience significant access delays even though no FDA drug shortage has been declared.
Most insurance plans require prior authorization with documented spirometry results before covering Ohtuvayre. The prior authorization process typically takes 2 to 4 weeks. Insurance formulary placement is still evolving for some plans, and the high list price has led the Institute for Clinical and Economic Review (ICER) to issue an access and affordability alert.
If you're struggling to locate your Ohtuvayre prescription, medfinder can help. medfinder calls specialty pharmacies on your behalf to check which ones have Ohtuvayre available and can fill your prescription — then texts you the results. This saves COPD patients from spending hours on hold.
Ohtuvayre is not a controlled substance, so it can be prescribed by any licensed prescriber with authority to prescribe respiratory medications. No special DEA registration is required. Prescribers who commonly write Ohtuvayre include:
Pulmonologists and respiratory specialists (most common for moderate-to-severe COPD)
Internal medicine physicians
Primary care physicians (family medicine, general practice)
Nurse practitioners (NPs) and physician assistants (PAs) with prescribing authority
Geriatricians (COPD is particularly prevalent in older adults; 55% of ENHANCE trial patients were 65+)
Ohtuvayre can be prescribed via telehealth, as it is not a controlled substance. Telehealth prescribers must ensure the patient has recent spirometry results to support the insurance prior authorization process.
No. Ohtuvayre (ensifentrine) is not a controlled substance and is not scheduled by the Drug Enforcement Administration (DEA). It can be prescribed by any licensed prescriber with appropriate authority — including pulmonologists, internists, primary care physicians, nurse practitioners, and physician assistants — without any special DEA registration requirements.
Because Ohtuvayre is not a controlled substance, it can also be prescribed via telehealth without the additional prescribing restrictions that apply to Schedule II-V drugs. There are no refill quantity limits imposed by the DEA, though insurance plans may still impose their own supply limits and prior authorization requirements.
The most common side effects reported in the ENHANCE Phase 3 clinical trials were:
Back pain (1.8%)
High blood pressure / hypertension (1.7%)
Bladder infection / urinary tract infection (1.3%)
Diarrhea (1.0%)
Psychiatric adverse reactions including suicidality: Ohtuvayre is associated with increased psychiatric events including insomnia, anxiety, depression, and rare suicide-related events. Monitor patients with psychiatric history closely.
Paradoxical bronchospasm: May occur immediately after inhalation; can be life-threatening. Discontinue Ohtuvayre and treat with rescue bronchodilator if this occurs.
Severe allergic reactions: Contraindicated in patients with known hypersensitivity to ensifentrine or any product ingredient.
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Tiotropium (Spiriva Respimat)
Once-daily LAMA bronchodilator; first-line COPD maintenance; widely covered by insurance; works via muscarinic receptor blockade (bronchodilation only, no anti-inflammatory effect)
Trelegy Ellipta
Once-daily triple therapy (ICS/LABA/LAMA) in one inhaler; reduces exacerbation risk in high-risk patients; contains a corticosteroid component
Breztri Aerosphere
Twice-daily triple therapy (ICS/LABA/LAMA) MDI inhaler; broad insurance coverage; contains a corticosteroid component
Roflumilast (Daliresp)
Oral once-daily PDE4 inhibitor; closest mechanistic relative to Ohtuvayre; generic available; approved for COPD with chronic bronchitis phenotype and frequent exacerbations
Prefer Ohtuvayre? We can find it.
Fluconazole (Diflucan)
moderateCYP2C9 inhibitor — may increase ensifentrine blood levels by slowing its metabolism
Rifampin (Rifadin)
moderateCYP2C9 inducer — may decrease ensifentrine blood levels, potentially reducing effectiveness
Other nebulizer medications (albuterol, ipratropium, budesonide)
majorDo NOT mix in the same nebulizer cup — compatibility not established. Use sequentially in separate nebulizer cups.
St. John's Wort
moderatePotent CYP2C9 inducer — may significantly reduce ensifentrine efficacy
Amiodarone (Pacerone)
moderateCYP2C9 inhibitor — may increase ensifentrine systemic exposure
Ohtuvayre (ensifentrine) represents a genuinely new chapter in COPD treatment — the first inhaled therapy in over 20 years to work through an entirely new mechanism. For patients who continue to struggle with breathlessness despite conventional COPD maintenance regimens, Ohtuvayre offers a meaningful steroid-free add-on option with evidence from the Phase 3 ENHANCE trials.
The real challenge with Ohtuvayre in 2026 is access — not supply. Specialty pharmacy exclusivity, prior authorization requirements from virtually all payers, and a $2,950/month list price create practical barriers. However, commercially insured patients may pay as little as $0 per month with the Verona Pathway Plus copay card, and Medicare patients have meaningful coverage pathways as well.
If you've been prescribed Ohtuvayre and are having trouble finding it at a pharmacy, medfinder can call specialty pharmacies on your behalf to find which ones have your medication in stock and can fill your prescription — then texts you the results. It's the simplest way to find Ohtuvayre without spending hours on hold.
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Our medication guides are researched and written to help patients make informed decisions. All content is reviewed for accuracy and updated regularly. Learn more about our standards
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