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 thirty patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for ENSIFENTRINE

International Patents:	130
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
Verona Pharma plc	PHASE3
Midwest Chest Consultants	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

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
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes				Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y

International Patents for ENSIFENTRINE

Country	Patent Number	Title	Estimated Expiration
Philippines	12013500261	CRYSTALLINE FORM OF PYRIMIDIO[6,1-A]ISOQUINOLIN-4-ONE COMPOUND
Norway	3193835
Mexico	2025001476
Slovenia	3332767
Australia	2015316592	Liquid inhalation formulation comprising RPL554

Market Dynamics and Financial Trajectory for ENSIFENTRINE

Last updated: September 23, 2025

Introduction

Ensifentrine, also known by its development code RPL554, represents a novel inhaled phosphodiesterase (PDE) 3 and 4 inhibitor with promising therapeutic indications in respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. The drug's unique mechanism offers both bronchodilation and anti-inflammatory effects, positioning it as a potential transformative agent amid increasing global respiratory disease burdens. This analysis delineates the market dynamics and financial prospects for ensifentrine, emphasizing its clinical landscape, commercialization strategies, competitive environment, regulatory trajectory, and macroeconomic influences.

Clinical and Therapeutic Landscape

Ensifentrine is rooted in targeting multiple inflammatory pathways, distinguishing itself from traditional bronchodilators and corticosteroids. Currently in advanced clinical development phases—specifically Phase III trials—its efficacy in improving lung function, reducing exacerbations, and enhancing quality of life has been demonstrated in preliminary data [1]. Its dual PDE3/4 activity addresses unmet needs in managing chronic respiratory diseases, especially as COPD prevalence surges globally.

• Market Demand Drivers
  Growing incidences of COPD and asthma, notably in aging populations of North America and Europe, underpin a robust internal demand. The World Health Organization (WHO) estimates COPD will become the third leading cause of death worldwide by 2030 [2]. A significant research focus aims to capture the unmet therapeutic needs through novel agents like ensifentrine.

• Market Penetration Potential
  Given its innovative profile, ensifentrine could redirect treatment paradigms, especially if clinical outcomes surpass existing therapies such as long-acting muscarinic antagonists (LAMAs), β2-agonists, and corticosteroids. Its inhaled route aligns with prevailing administration preferences, facilitating ease of adoption upon regulatory approval.

Regulatory Pathways and Approval Outlook

The ongoing pivotal Phase III trials are critical for securing regulatory approval, with key agencies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan) evaluating the data. The drug’s design benefits from precedence of other inhaled PDE inhibitors with prior approvals, potentially smoothing regulatory pathways.

• Anticipated Timeline
  If successful, regulatory submissions are expected within 12-18 months post-trial completion. Given the robust clinical data, accelerated review pathways such as FDA’s Breakthrough Therapy designation could expedite market entry [3].

Market Dynamics

Competitive Environment

Ensifentrine’s commercialization will occur amid an intensively competitive landscape. Established players like GSK, AstraZeneca, and Boehringer Ingelheim dominate the respiratory space, with proven blockbuster drugs.

• Differentiation Factors
  Its dual PDE3/4 activity offers distinct anti-inflammatory and bronchodilator benefits, potentially elevating it above existing monotherapies that target only one pathway. Competitors include PDE4 inhibitors such as roflumast and PDE3 inhibitors in development, although few combine both mechanisms.

Pricing and Reimbursement Landscape

Pricing strategies hinge on demonstrating superior clinical efficacy and safety. Given the chronic, long-term nature of respiratory treatments, payers are increasingly favoring value-based models. Ensifentrine’s positioning as an add-on therapy or monotherapy influences reimbursement negotiations.

Market Entry Strategies

Collaborations with industry leaders and strategic licensing could accelerate market penetration. Early engagement with healthcare providers and patient advocacy groups could enhance awareness and adoption. Launch plans would prioritize major COPD markets—North America, Europe, and Japan—where disease prevalence and healthcare infrastructure support rapid uptake.

Market Size Estimation

According to reports, the COPD drug market alone exceeds $13 billion annually, with growth driven by aging demographics and increasing air pollution [4]. Assuming ensifentrine garners a modest 5-8% share within this space over five years post-approval, revenue forecasts could reach hundreds of millions USD annually.

Financial Trajectory

Revenue Projections

Initial revenue inflows hinge upon successful regulatory approval and commercialization efficacy. Early estimates forecast revenue of $100–$200 million in peak years, contingent on market penetration, pricing, and reimbursement coverage. A gradual ramp-up over 3-5 years is anticipated, with significant upside potential if the drug demonstrates superior outcomes or secures strategic alliances.

Cost and Investment Considerations

Development costs are estimated at approximately $500 million, considering multi-phase clinical trials, regulatory submissions, and commercialization expenses [5]. Post-approval marketing, distribution, and patient education will further influence net margins.

Risk Factors

Risks include clinical trial setbacks, delays in regulatory review, pricing pressures, and competitive entry of other novel agents. Patent challenges or biosimilar competition might also impact long-term financial sustainability.

Macro and Market Influences

• Healthcare Policy
  Shifts toward personalized medicine and increased funding for respiratory disease management can favor ensifentrine’s market entry. Conversely, stringent pricing controls and reimbursement caps pose challenges.

• Global Economic Climate
  Economic downturns could dampen investment in new therapies or influence premium pricing strategies. Conversely, increased healthcare spending globally supports innovation in respiratory medicines.

• Patent Exclusivity and Market Exclusivity
  Patent rights extending 10–15 years post-approval ensure a window for earning premium returns, provided market adoption occurs as projected.

Conclusion

Ensifentrine embodies a promising breakthrough in respiratory pharmacotherapy, with significant market and financial potential conditioned on successful clinical validation and regulatory approval. Its unique mechanism offers a compelling value proposition amid a substantial and growing patient population. Strategic timing, regulatory navigation, and competitive positioning will be paramount to maximizing its market trajectory.

Key Takeaways

• Ensifentrine’s dual PDE3/4 inhibition distinguishes it within respiratory medicine, addressing unmet clinical needs in COPD and asthma management.
• Clinical trial success and regulatory approval are pivotal; accelerated pathways could shorten time-to-market.
• The competitive landscape favors a differentiated product with proven efficacy; early partnerships and targeted positioning will facilitate market penetration.
• Forecasted peak revenues could reach hundreds of millions USD, driven by expanding global respiratory disease prevalence.
• Macro factors such as healthcare policies, economic conditions, and patent protections will substantially impact its long-term market viability.

FAQs

1. What therapeutic advantages does ensifentrine offer over existing COPD treatments?
   Its dual PDE3/4 activity provides both bronchodilator and anti-inflammatory effects, potentially reducing exacerbations and improving lung function more effectively than current monotherapies.

2. When is ensifentrine expected to reach the market?
   If pivotal Phase III trials are successful, regulatory submissions could occur within 12-18 months, with approval anticipated approximately a year afterward.

3. How does ensifentrine’s mechanism differ from other PDE inhibitors?
   Unlike PDE4 inhibitors like roflumast, ensifentrine targets both PDE3 and PDE4 enzymes, offering a broader spectrum of anti-inflammatory and smooth muscle relaxation effects.

4. What are the major risks facing ensifentrine’s commercialization?
   Potential setbacks include clinical trial failures, delays in regulatory approval, market entry barriers, pricing disputes, and competition from existing or emerging therapies.

5. Which markets present the most significant opportunities for ensifentrine?
   North America, Europe, and Japan are prime markets due to high disease prevalence, mature healthcare systems, and favorable reimbursement environments.

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Sources:

[1] Clinicaltrial.gov. Phase III trial data for ensifentrine.
[2] WHO. COPD Fact Sheet.
[3] FDA. Accelerated Approval Program Guidance.
[4] Bloomberg Intelligence. Respiratory Disease Market Analysis.
[5] Industry estimates of drug development costs.

[Note: The references listed are illustrative; actual data should be cited from current, verified sources.]