OMIDENEPAG ISOPROPYL - Generic Drug Details

What are the generic drug sources for omidenepag isopropyl and what is the scope of patent protection?

Omidenepag isopropyl is the generic ingredient in one branded drug marketed by Ocuvex Therap and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omidenepag isopropyl has one hundred and thirty-four patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for OMIDENEPAG ISOPROPYL

International Patents:	134
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	1
What excipients (inactive ingredients) are in OMIDENEPAG ISOPROPYL?	OMIDENEPAG ISOPROPYL excipients list
DailyMed Link:	OMIDENEPAG ISOPROPYL at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION;OPHTHALMIC

^*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 OMIDENEPAG ISOPROPYL

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

Sponsor	Phase
Santen Pharmaceutical Asia Pte. Ltd.	Phase 4

See all OMIDENEPAG ISOPROPYL clinical trials

Pharmacology for OMIDENEPAG ISOPROPYL

Drug Class	Prostaglandin E2 Receptor Agonist
Mechanism of Action	Prostaglandin E2 Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for OMIDENEPAG ISOPROPYL

S01EX	Other antiglaucoma preparations
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for OMIDENEPAG ISOPROPYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes			Y
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes			Y
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes			Y
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes			Y
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes				Y
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		RX	Yes	Yes			Y

International Patents for OMIDENEPAG ISOPROPYL

Country	Patent Number	Title	Estimated Expiration
Taiwan	I842692
South Korea	20160099582
Hong Kong	1170490
China	105899209	含有吡啶基氨基乙酸化合物的药物制剂 (Pharmaceutical preparation including pyridylamino acetic acid compound)
South Korea	101681347
Chile	2016001756	Preparación farmacéutica que comprende 0,001-0,003 pv de 6-4-pirazol-1-ilbencilpiridin-3-ilsulfonilaminometilpiridin-2-ilaminoacetato de isopropilo o una sal del mismo uso para el tratamiento o prevención de glaucoma o hipertensión ocular.

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Omidenepag Isopropyl

Last updated: July 30, 2025

Introduction

Omidenepag isopropyl, a novel ophthalmic agent, has emerged as a promising therapy for glaucoma and ocular hypertension. With its unique mechanism of action as a selective prostaglandin EP2 receptor agonist, this drug offers potential advantages over traditional treatments. This report provides an in-depth analysis of the market dynamics and financial trajectory of omidenepag isopropyl, emphasizing industry trends, regulatory environment, competitive landscape, and commercial potential.

Market Overview and Therapeutic Landscape

Glaucoma affects over 80 million people worldwide, projected to reach nearly 112 million by 2040, representing a significant market opportunity [1]. The primary goal of treatment is intraocular pressure (IOP) reduction to prevent optic nerve damage. Current first-line therapies include prostaglandin analogs, beta-blockers, and combination formulations. Despite their efficacy, these treatments face limitations related to tolerability, compliance, and side effects such as eyelash growth or iris pigmentation.

Omidenepag isopropropyl introduces a novel class, targeting the EP2 receptor, and has demonstrated promising IOP-lowering effects with a favorable safety profile. Its differentiation stems from potentially fewer side effects and improved tolerability, making it a compelling addition to the therapeutic arsenal.

Regulatory Timeline and Market Approval

The regulatory journey of omidenepag isopropyl has notably influenced its market trajectory. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved it in 2018 for medical use (brand name: Eybelis), following positive Phase III trial data illustrating non-inferiority to existing prostaglandins [2].

In the United States and Europe, the drug is still seeking approval, with a notable submission to the U.S. FDA based on clinical data indicating significant IOP reduction and tolerability advantages. Regulatory decisions in these markets could significantly impact sales growth potential.

Market Dynamics and Competitive Positioning

Growth Drivers

1. Unmet Needs and Differentiation: The demand for treatments with fewer side effects and enhanced compliance drives interest in omidenepag isopropyl. Its distinct mechanism may appeal to patients intolerant to current therapies.

2. Aging Population: The global rise in elderly populations predisposes to glaucoma, fueling long-term market expansion.

3. Pipeline and Clinical Evidence: Ongoing Phase III trials in Western markets and positive real-world data bolster confidence in market adoption potential.

Challenges and Risks

1. Regulatory Uncertainty: Delays or rejection in key markets like the U.S. or Europe could hinder commercialization.

2. Competitive Landscape: The market is saturated with well-established prostaglandin analogs (e.g., latanoprost, travoprost). Omidenepag must demonstrate significant advantages to secure market share.

3. Pricing and Reimbursement: Pricing strategies and reimbursement policies influence market penetration and profitability.

Key Competitors

• Latanoprost and its variants: Market leaders with robust sales histories.
• Netarsudil (Rhopressa): Another novel glaucoma agent targeting rho kinase.
• Netarsudil + Latanoprost Combination: Offering enhanced efficacy, setting a competitive benchmark.

Financial Trajectory and Market Penetration

Initial Launch and Revenue Projections

In Japan and other approval jurisdictions, early commercialization began around 2018, with initial sales modest but growing steadily. Industry estimates project compound annual growth rates (CAGRs) of 20–30% post-approval in primary markets, assuming regulatory approval in the U.S. and Europe within the next 2-3 years.

Market Penetration Strategy

Pharmaceutical companies often employ a phased approach:

• Early Access and Differentiation: Focus on ophthalmologists and specialists who seek novel treatments.
• Market Expansion: Leverage real-world efficacy data to broaden indications.
• Pricing and Reimbursement Negotiation: Establish a competitive pricing structure aligned with value demonstration.

Revenue Milestones

• Short-Term (1-3 Years Post-Launch): Estimated revenues of $100-200 million globally, primarily driven by Japan, with initial U.S. and European contributions.
• Mid-Term (4-7 Years): Increased market share with expanded indications and combination therapies, potentially surpassing $500 million annually.
• Long-Term (8+ Years): Integration into combination therapies with established agents may drive revenues toward $1 billion annually, contingent upon approval and market uptake.

Factors Influencing Financial Trajectory

• Regulatory Approval Timelines: Faster approvals accelerate revenue streams.
• Market Penetration Rates: Adoption by ophthalmologists and insurance coverage significantly impact sales.
• Pricing Strategy: Premium pricing can improve margins but may limit market access.
• Pipeline Developments: Additional indications or formulations (e.g., sustained-release) can expand the addressable population.

Emerging Trends and Opportunities

1. Combination Therapies: Partnering with existing glaucoma medications to enhance efficacy.
2. Biologics and Novel Delivery Systems: Exploring sustained-release formulations to improve compliance.
3. Global Expansion: Entering emerging markets where glaucoma prevalence is rising.

Regulatory and Policy Considerations

Regulatory agencies are increasingly emphasizing real-world evidence and comparative effectiveness data, influencing approval and reimbursement decisions. Strategic alignment with regulatory expectations enhances market prospects. Furthermore, navigating patent landscapes and exclusivity periods will determine long-term profitability.

Impact of Global Economic Factors

Economic variability, healthcare expenditure, and reimbursement policies directly influence pricing and adoption. Cost-effectiveness analyses demonstrating superior safety profiles or reduced long-term burden can bolster reimbursement negotiations.

Conclusion

Omidenepag isopropyl possesses strong market potential as a novel glaucoma therapy, contingent on successful regulatory approvals across key markets and effective commercialization strategies. Its differentiated mechanism offers opportunities to address unmet needs, especially among patients intolerant to traditional prostaglandins. The financial trajectory is promising, with expected growth fueled by demographic trends, pipeline expansion, and strategic market entry.

---

Key Takeaways

• Market Expansion Is Paramount: Regulatory approvals in the U.S. and Europe are crucial for accelerating revenue growth.
• Differentiation Drives Adoption: Its safety profile and mechanism of action position omidenepag isopropyl to capture market share from established therapies.
• Pipeline and Indications Are Key: Further indications and combination approaches will diversify revenue streams.
• Pricing and Reimbursement Are Critical: Navigating pricing strategies in different healthcare systems will determine profitability.
• Long-Term Growth Is Likely: With successful market penetration and pipeline expansion, revenues could approach $1 billion annually over a decade.

---

FAQs

1. When is omidenepag isopropyl expected to be approved in the U.S.?
Approval timelines depend on ongoing clinical trial results and FDA review processes. If current Phase III data is positive, an approval could occur within the next 1-2 years, projecting potential market entry by 2024-2025.

2. How does omidenepag isopropyl differ from existing prostaglandin analogs?
It selectively targets the EP2 receptor, potentially offering comparable IOP reduction with fewer side effects like pigmentation changes and eyelash growth, enhancing tolerability and compliance.

3. What are the primary challenges for commercial success?
Key challenges include regulatory delays, competition from well-established therapies, pricing pressures, and convincing clinicians of its distinct advantages over existing treatments.

4. What strategic moves could enhance its market penetration?
Formulary inclusion, demonstrating superior safety and efficacy, establishing strong relationships with ophthalmologists, and developing combination therapies will be vital.

5. What is the long-term revenue outlook for omidenepag isopropyl?
If approvals are secured globally, and market adoption progresses as anticipated, revenues could reach or exceed $1 billion annually within 8-10 years, driven by expanding indications and pipeline developments.

---

Sources:

1. [World Health Organization, Glaucoma Fact Sheet, 2021]
2. [Japanese Ministry of Health, Labour and Welfare, Approval Notice for Eybelis (2018)]