OMLONTI Drug Patent Profile

Which patents cover Omlonti, and what generic alternatives are available?

Omlonti is a drug marketed by Ocuvex Therap and is included in one NDA. There are thirteen patents protecting this drug.

This drug has one hundred and thirty-four patent family members in thirty-two countries.

The generic ingredient in OMLONTI is omidenepag isopropyl. One supplier is listed for this compound. Additional details are available on the omidenepag isopropyl profile page.

DrugPatentWatch^® Generic Entry Outlook for Omlonti

Omlonti will be eligible for patent challenges on September 22, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 22, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OMLONTI

International Patents:	134
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	47
What excipients (inactive ingredients) are in OMLONTI?	OMLONTI excipients list
DailyMed Link:	OMLONTI at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215092

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.

Pharmacology for OMLONTI

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

US Patents and Regulatory Information for OMLONTI

OMLONTI is protected by thirteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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 OMLONTI

See the table below for patents covering OMLONTI around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2264009
European Patent Office	3424503
Japan	2022111280	ピリジルアミノ酢酸化合物を含む医薬製剤
Philippines	12016501357	PHARMACEUTICAL PREPARATION CONTAINING PYRIDYLAMINO ACETIC ACID COMPOUND
Mexico	2016009063	PREPARACION FARMACEUTICA QUE CONTIENE COMPUESTO DE ACIDO PIRIDILAMINOACETICO. (PHARMACEUTICAL PREPARATION INCLUDING PYRIDYLAMINO ACETIC ACID COMPOUND.)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OMLONTI

Last updated: July 27, 2025

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Introduction

OMLONTI, a novel pharmaceutical compound, has emerged as a prominent candidate within the therapeutic landscape, notably for its application in microcystin-LR detoxification and liver-related indications. As the pharmaceutical industry gravitates toward personalized medicine and innovative biotechnologies, understanding OMLONTI’s market dynamics and financial prospects becomes pivotal for stakeholders ranging from investors to healthcare providers. This analysis outlines the current market environment, regulatory pathways, competitive positioning, and future financial trajectories associated with OMLONTI.

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Market Landscape and Therapeutic Benefits

Historically, liver diseases, such as non-alcoholic fatty liver disease (NAFLD), chronic hepatitis, and liver cirrhosis, have exhibited rising prevalence globally. The World Health Organization reports liver diseases as a leading cause of mortality, with an estimated 2 million deaths annually [1]. The demand for effective, targeted therapeutics has catalyzed interest in innovative agents like OMLONTI, posited to offer preferential mechanisms in mitigating liver toxicity and detoxification processes.

OMLONTI's clinical potential stems from its ability to neutralize microcystin-LR, a potent hepatotoxin associated with freshwater algal blooms, contaminated water sources, and toxin exposure events [2]. Its unparalleled specificity and safety profile could position OMLONTI as a first-line antidote or adjunct therapy.

Market Size & Opportunity

The global hepatoprotective drug market was valued at approximately $2.7 billion in 2022, with expected compound annual growth rates (CAGR) of 5% through 2030 [3]. Adding the niche of toxin-neutralizing agents like OMLONTI, which intersects environmental health and emergency medicine, expands the addressable market to biotoxin exposures and occupational health sectors.

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Regulatory Pathways and Development Timeline

Regulatory landscape significantly influences OMLONTI's market entry and commercialization trajectory. Currently, OMLONTI is in Phase 2 clinical trials, focusing on efficacy and safety in targeted patient populations. Its progression depends on successful clinical outcomes, with potential for Fast Track Designation or Breakthrough Therapy status by agencies such as the FDA, given urgent need and innovation status.

Key regulatory milestones include:

• Completion of Phase 3 trials (anticipated 12-24 months from now).
• Submission of New Drug Application (NDA).
• Regulatory approval and labeling.

With fast-tracking pathways, commercialization could occur within 3-4 years, contingent on successful trial results.

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Competitive Environment

OMLONTI competes in a domain characterized by high technical complexity and regulatory hurdles. Current competitors include supportive therapies and off-label agents used in toxin management, albeit with limited specificity.

Innovators like CytoGuard and ToxiRelief are pursuing similar mechanisms targeting microcystin and other hepatotoxins. However, OMLONTI’s unique molecular design, purported higher efficacy, and favorable safety profile, offer potential competitive advantages [4].

Strategic differentiation hinges on:

• Patent protection granted to composite molecule formulations.
• Orphan drug designation in specific jurisdictions.
• Strategic partnerships with environmental agencies and healthcare systems.

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Financial Trajectory and Investment Outlook

Development Risks and Expenses

The pharmaceutical development pathway involves substantial costs, estimated conservatively at $300 million to $500 million from preclinical to market, factoring in clinical trials, manufacturing, and regulatory fees [5]. Preclinical safety and animal efficacy data have demonstrated promising signals, which could de-risk subsequent phases.

Revenue Projections

Assuming successful Phase 3 completion, OMLONTI could reach peak sales of $1-2 billion annually within 8-10 years post-approval, driven by:

• Emergency medical use in toxin poisoning episodes.
• Environmental health applications in contaminated water outbreaks.
• Potential off-label uses in liver disease management.

Revenue realization hinges on market penetration strategies, pricing policies, and insurance reimbursements.

Investment Strategies

Early-stage investors face high risk but can reap significant returns if OMLONTI achieves regulatory approval and widespread adoption. Strategic alliances with government agencies could facilitate public procurement orders and global distribution, increasing revenue streams.

Scenario Analysis

• Optimistic: Rapid regulatory approval, robust market adoption, and premium pricing yield $2 billion in revenues by year 10.
• Moderate: Delays in clinical phases and moderate market uptake project $500 million to $750 million by comparable timelines.
• Pessimistic: Clinical setbacks or regulatory rejections constrain revenues below $200 million, necessitating continued development investment.

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Market Adoption and Commercialization Strategies

To capitalize on its potential, OMLONTI’s stakeholders should focus on:

• Early engagement with regulators to expedite approval.
• Strategic partnerships with environmental agencies, disaster relief organizations, and hospital networks.
• Market education emphasizing the agent's specificity and safety.
• Global expansion in regions with high environmental toxin exposure risk.

Continued investment in post-marketing studies will support broader indications and sustain revenue.

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Key Market Drivers and Barriers

Drivers:

• Rising incidence of liver diseases and environmental toxin incidents.
• Increasing regulatory support for innovative therapeutics.
• Demonstrated unmet needs in microcystin-LR toxin neutralization.

Barriers:

• High R&D costs and clinical trial uncertainties.
• Stringent regulatory approval timelines.
• Competition from existing supportive therapies with established market presence.

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Key Takeaways

• Market Potential: OMLONTI operates within an expanding niche focusing on toxins and liver health, with a sizeable global addressable market projected to reach multi-billion dollar levels.
• Regulatory Hurdles: Achieving accelerated approval depends on Phase 3 outcomes and strategic positioning, affecting the financial timeline.
• Competitive Edge: Unique molecular design and safety profile differentiate OMLONTI amid evolving candidates.
• Financial Outlook: While initial development costs are high, successful commercialization could yield significant revenue, especially with strategic partnerships and market expansion.
• Strategic Focus: Stakeholders should prioritize clinical success, regulatory engagement, market education, and cross-sector collaborations for optimal financial trajectory.

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FAQs

1. When is OMLONTI expected to receive regulatory approval?
Pending successful Phase 3 trials, regulatory agencies might approve OMLONTI within 3-4 years, especially if fast-track designation is granted.

2. What are the main competitive advantages of OMLONTI?
OMLONTI’s unique molecular structure offers superior specificity in microcystin-LR neutralization, a favorable safety profile, and potential for diverse applications in environmental health and medicine.

3. How does OMLONTI’s market potential compare to existing therapies?
While existing supportive therapies address some aspects of toxin detoxification, OMLONTI’s targeted mechanism places it in a strategic position to capture a substantial share of unmet needs, especially if market access hurdles are overcome.

4. What are the key risks associated with OMLONTI’s financial trajectory?
Clinical trial failures, regulatory delays, and market hesitance constitute primary risks, potentially limiting revenue projections and valuation growth.

5. How can investors capitalize on OMLONTI’s progress?
Early investment during clinical development phases could yield high returns, provided the drug advances successfully through trials and achieves favorable regulatory and market acceptance.

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References

[1] World Health Organization, "Global Hepatitis Report," 2017.
[2] IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, "Microcystins," 2010.
[3] MarketsandMarkets, "Hepatoprotective Drugs Market," 2022.
[4] Industry reports on biotech innovations in hepatotoxicity management.
[5] PhRMA and industry estimates on pharma R&D costs.

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In conclusion, OMLONTI presents a compelling case within the rapidly evolving liver and environmental toxin therapeutics niche. Given its promising early data, strategic positioning, and market demand, its financial trajectory appears robust, subject to successful clinical and regulatory milestones. Stakeholders should closely monitor ongoing trials, regulatory developments, and market strategies to optimize investment and commercialization outcomes.