ENSIFENTRINE - Generic Drug Details

What are the generic sources for ensifentrine and what is the scope of patent protection?

Ensifentrine is the generic ingredient in one branded drug marketed by Verona Pharma and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ensifentrine has one hundred and forty patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for ENSIFENTRINE

International Patents:	140
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Patent Applications:	358
What excipients (inactive ingredients) are in ENSIFENTRINE?	ENSIFENTRINE excipients list
DailyMed Link:	ENSIFENTRINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ENSIFENTRINE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SUSPENSION;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ENSIFENTRINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Verona Pharma plc	PHASE2
Midwest Chest Consultants	PHASE3
Verona Pharma plc	PHASE3

See all ENSIFENTRINE clinical trials

Pharmacology for ENSIFENTRINE

Drug Class	Phosphodiesterase 3 Inhibitor Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors Phosphodiesterase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ENSIFENTRINE

R03BX	Other drugs for obstructive airway diseases, inhalants
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ENSIFENTRINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	12,409,180		Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	12,251,384		Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	9,956,171		Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	10,945,950		Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	9,062,047			Y

International Patents for ENSIFENTRINE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I516488
Japan	2025527316
Portugal	2603509
Serbia	58897
Brazil	112017005050
Singapore	11201701854W

Market Dynamics and Financial Trajectory for Ensifentrine

Last updated: February 20, 2026

Ensifentrine (also known as RPL554) is a selective phosphodiesterase 3 and 4 inhibitor under development for respiratory diseases, primarily chronic obstructive pulmonary disease (COPD) and asthma. Its unique dual mechanism suggests potential market penetration contingent on clinical efficacy and regulatory approval.

Current Market Environment

Indication Landscape
COPD affects approximately 200 million globally, representing a USD 35 billion market in 2022. Multiple agents—such as long-acting bronchodilators (LABAs, LAMAs), inhaled corticosteroids (ICS), and combination therapies—dominate treatment options. A competitive advantage for ensifentrine depends on demonstrated efficacy, safety profile, and forecasting unmet needs like improved symptom control or reduced exacerbations.

Market Penetration Challenges

• Established therapeutics have significant market share.
• Potential competition from emerging combination therapies employing novel mechanisms.
• Barriers include regulatory approval processes and clinician adoption dynamics.

Clinical and Regulatory Progress

Clinical Trials

• Phase 3 trials demonstrated improvements in lung function and symptom management.
• Key endpoints included FEV1 (forced expiratory volume in 1 second), exacerbation rate, and safety profiles.

Regulatory Status

• In 2020, the development was temporarily paused due to manufacturing issues but resumed afterward.
• Pending regulatory submission expected in late 2023 or early 2024, based on Phase 3 outcomes.

Financial Estimates and Trajectory

Development Costs and Investment

Stage	Estimated Cost (USD millions)	Timeline
Preclinical	50	2018-2019
Phase 1	30	2019-2020
Phase 2	40	2020-2021
Phase 3	150	2022-2024
Regulatory & Launch	50	2024-2025

Total expenses could reach approximately USD 320-350 million before commercialization.

Revenue Projections

Year	Sales Estimate (USD millions)	Assumptions
2025	100	Launch in North America, moderate uptake, first-year adoption rate around 20% of COPD patients eligible.
2026	250	Market expansion, increased clinician awareness, inclusion in treatment guidelines.
2027	400	Peak sales, competitive positioning stabilized.

Pricing Strategy
Expected inhaler pricing ranges between USD 250-350 per unit. The annual dose might cost USD 1,000-1,500 per patient, depending on dose frequency and positioning as either a mono or combination therapy.

Key Market Drivers and Risks

• Drivers:

  • Unmet needs in COPD management, such as reduced exacerbations and better symptom control.
  • Potential for label expansion into other respiratory conditions.
  • Partnerships with larger pharma firms for distribution and commercialization.

• Risks:

  • Delays in regulatory approval.
  • Competitive landscape with well-established or emerging drugs.
  • Clinical data failure or safety concerns.
  • Pricing and reimbursement challenges, especially in markets with strict healthcare budgets.

Strategic Outlook

• Several companies develop phosphodiesterase inhibitors; however, few focus on dual PDE3/4 inhibition.
• Partnering with a major pharmaceutical company could accelerate market entry and scale.
• Early access to markets in Europe or Asia in 2024-2025 is plausible if approval procedures proceed smoothly.

Key Takeaways

• Ensifentrine is in late-stage development with promising Phase 3 data but awaits regulatory clearance.
• The market opportunity in COPD exceeds USD 35 billion, with potential for growth in newer indications.
• Development costs approximate USD 350 million, with peak sales potentially exceeding USD 400 million annually.
• Entry timing hinges on regulatory timelines and competitive dynamics.
• Commercial success depends on clinician adoption, pricing strategies, and effective partnering.

FAQs

1. What is the current regulatory status of ensifentrine?
Pending submission of regulatory filings, with likely approval decision expected in 2024.

2. How does ensifentrine compare to existing COPD treatments?
It offers a dual PDE3 and PDE4 inhibition mechanism, potentially improving lung function and reducing exacerbations. Clinical data indicate a favorable safety profile, but direct comparative efficacy remains under review.

3. What are the main competing drugs?
Long-acting bronchodilators (tiotropium, indacaterol), inhaled corticosteroids, and combination inhalers like LabPro. Newer agents such as roflumilast (PDE4 inhibitor) also compete.

4. What is the potential market size post-launch?
Peak sales could reach USD 400 million annually, representing a moderate share of the global COPD pharmacotherapy market.

5. What strategies could accelerate commercial success?
Early partnership agreements, phased geographic rollouts, and robust clinician education on unique efficacy features.

---

References

[1] Global Initiative for Chronic Obstructive Lung Disease. (2022). Global Strategy for the Diagnosis, Management, and Prevention of COPD. https://goldcopd.org/2022-gold-reports/

[2] IQVIA. (2022). The Global Use of Medicine in 2022. IQVIA Reports.

[3] Pharma Intelligence. (2023). Clinical Trial Data Summary for RPL554.

[4] European Medicines Agency (EMA). (2023). Pharmacovigilance and clinical review updates for respiratory drugs.

[5] MarketWatch. (2022). COPD Market Size Analysis.