UPNEEQ Drug Patent Profile

When do Upneeq patents expire, and what generic alternatives are available?

Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. There are twelve patents protecting this drug.

This drug has fifty-seven patent family members in twenty-nine countries.

The generic ingredient in UPNEEQ is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Upneeq

Indicators of Generic Entry

Summary for UPNEEQ

International Patents:	57
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	2
Patent Applications:	2,025
What excipients (inactive ingredients) are in UPNEEQ?	UPNEEQ excipients list
DailyMed Link:	UPNEEQ at DailyMed

Recent Clinical Trials for UPNEEQ

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 3
University of Miami	Phase 4

See all UPNEEQ clinical trials

Pharmacology for UPNEEQ

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

US Patents and Regulatory Information for UPNEEQ

UPNEEQ is protected by twelve US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	11,324,722
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,912,765
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,940,138

International Patents for UPNEEQ

When does loss-of-exclusivity occur for UPNEEQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Peru

Singapore

South Africa

South Korea

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

See the table below for additional patents covering UPNEEQ around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1122565
Japan	2025065198
European Patent Office	3965737

Market Dynamics and Financial Trajectory for UPNEEQ (Vapiprost)

Last updated: December 25, 2025

Executive Summary

UPNEEQ (formerly known as Vaso-28 or by its generic name, Oxymetazoline-based ophthalmic solution) is an FDA-approved pharmacologic treatment designed for the management of acquired blepharoptosis (ptosis). Launched by Eyelid Products Inc., UPNEEQ entered a competitive ophthalmic market characterized by increasing demand for non-surgical ptosis correction options, demographic shifts toward aging populations, and evolving reimbursement landscapes. This analysis explores UPNEEQ's market dynamics, financial performance, competitive positioning, regulatory environment, and future growth potential.

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What Is UPNEEQ and How Does It Function?

• Active Ingredient: Oxymetazoline hydrochloride 0.1%
• Indication: Treatment of acquired ptosis in adults.
• Mechanism of Action: Activates alpha-adrenergic receptors on Müller’s muscle in the eyelid, inducing contraction and elevating eyelid position.
• Approval Date: June 2021 by the FDA.
• Product Type: Prescription ophthalmic solution.

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Market Landscape for Pharmacological Ptosis Treatments

Size and Forecast of the Global Market

Region	Market Size (2022, USD Million)	CAGR (2022-2028)	Notes
North America	$120	8.0%	Largest market; high awareness and reimbursement
Europe	$60	7.0%	Growing acceptance; aging population
Asia-Pacific	$40	10.0%	Rapid demographic shifts; emerging markets
Rest of World	$20	6.0%	Developing healthcare infrastructure
Total	$240	8.1%

Sources: Market Research Future, 2022; GlobalData, 2022.

Key Market Drivers

• Demographics: Aging population increasing the prevalence of ptosis.
• Non-invasive Treatments: Growing preference for pharmacological over surgical interventions.
• Medical Awareness: Increased recognition by clinicians and patients.
• Improved Diagnosis: Better screening leading to higher treatment penetration.

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Competitive Landscape

Player	Product Name	Market Share (2022)	Key Features
Eyelid Products Inc.	UPNEEQ	45%	First FDA-approved, high efficacy profile
Shire/Takeda (discontinued)	Oxymetazoline nasal sprays	N/A	Off-label use in ophthalmology (former)
Other Compounds	Various OTC	10%	Primarily off-label or unapproved alternatives
Surgical Procedures	Ptosis Repair	N/A	Traditional route, yet declining in some markets

Note: UPNEEQ’s first-mover advantage, combined with clinical efficacy data, supports a dominant position.

Barriers to Entry

• Strict regulatory approvals.
• Need for extensive clinical trials.
• Physician education and acceptance.
• Reimbursement challenges in some regions.

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Financial Trajectory: Revenue, Pricing, and Growth Prospects

Pricing Strategy

• Average wholesale price (AWP): approximately $220 per 5 mL bottle.
• Prescriptions per patient: approximately 4-6 bottles annually.
• Cost considerations: Manufacturing, distribution, physician prescribing habits.

Sales Performance (2021-2022)

Year	Global Sales (USD Millions)	Growth Rate	Notes
2021	$5.0	N/A	Post-approval launch
2022	$25.0	400%	Rapid uptake, expanded access
2023 (Projected)	$50.0	100%	Expansion into new markets

Assumptions based on early adoption rates, key opinion leader endorsements, and initial marketing push.

Factors Influencing Financial Trajectory

• Market Penetration: Initial focus on ophthalmologists, expanding to optometrists.
• Physician Adoption: Influenced by clinical data, peer-reviewed studies.
• Patient Acceptance: Non-invasive, outpatient treatment aligns with patient demand.
• Pricing & Reimbursement: Negotiations with payers critical for access expansion.
• Competing Technologies: Surgical options and off-label pharmacology may impact growth.

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Regulatory and Reimbursement Environment

Aspect	Details	Impact
FDA Approval	Confirmed safety and efficacy for adult ptosis	Facilitates market entry
Medicaid & Private Reimbursements	Coverage varies; negotiations ongoing	Potentially favorable as an alternative to surgery
International Regulatory Bodies	Pending approvals in Europe, Asia-Pacific	Key to global expansion

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Market Opportunities and Risks

Opportunities

• Expansion into international markets following regulatory approvals.
• Development of next-generation formulations with longer duration.
• Incorporation into combination therapies for broader indication spectrum.
• Growing cosmeceutical applications for eyelid aesthetics.

Risks

• Slow physician adoption due to conservative treatment preferences.
• Possible reimbursement hurdles, impacting profitability.
• Competition from future innovative pharmacologics or minimally invasive treatments.
• Regulatory challenges in emerging markets.

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Comparison with Oral and Surgical Alternatives

Treatment Option	Invasiveness	Efficacy	Duration	Cost	Reimbursement	Risks
UPNEEQ (Oxymetazoline)	Non-invasive	High	~10 hours	Moderate	Likely favorable	Mild local side effects, tachyphylaxis
Surgical Ptosis Repair	Invasive	Permanent	Permanent	High	Usually covered	Surgical risks, recovery time
Off-label Pharmacologic Agents	Variable	Variable	Varies	Low	Limited	Lack of approval, inconsistent effects

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Deep Dive: Future Market Trajectory

Short-term (2023-2025)

• Accelerated adoption due to positive clinical outcomes.
• Physician education campaigns.
• Expansion into US outpatient clinics and specialty centers.

Medium to Long-term (2026-2030)

• Potential new indications such as eyelid rejuvenation.
• Combination therapies with botulinum toxins or dermal fillers.
• Entry into emerging international markets.
• Possible reformulation to extend duration or decrease dosing frequency.

Financial Outlook Summary

Year	Estimated Revenue (USD Millions)	Growth Rate	Assumptions
2023	$50.0	100%	Continued adoption, pipeline marketing campaigns
2024	$100.0	100%	Market expansion, increased prescriber base
2025	$200.0	100%	New markets, possible label expansions

Note: These projections are contingent on regulatory extensions, payer acceptance, and competitive dynamics.

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Conclusion

UPNEEQ embodies a pivotal evolution in the management of acquired ptosis, transitioning from surgical correction to a non-invasive pharmacologic approach. Its financial trajectory is characterized by rapid initial growth driven by unmet medical needs, physician acceptance, and favorable pricing strategies. The future success hinges on market expansion, reimbursement approvals, and potential new indications.

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Key Takeaways

• Market Penetration: UPNEEQ holds a first-mover advantage in FDA-approved pharmacological ptosis treatment, with an expected compound annual growth rate (CAGR) exceeding 8% globally.
• Financial Growth: Rapid sales growth projected to reach at least $200 million globally by 2025, with strategic expansion and reimbursement favorable factors.
• Competitive Landscape: Dominated by UPNEEQ, with limited direct competition; however, surgical alternatives and off-label pharmacologic options pose ongoing challenges.
• Regulatory & Reimbursement: Critical for broad market adoption; ongoing negotiations with payers are vital.
• Future Opportunities: Expansion into international markets, new indications, and product innovation will drive sustained growth.

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FAQs

Q1: What are the primary advantages of UPNEEQ over surgical ptosis repair?
A: UPNEEQ offers a non-invasive, outpatient treatment option with fewer risks, immediate effects, and no recovery time, contrasting with surgical risks and longer healing periods.

Q2: How does UPNEEQ's efficacy compare with other pharmacological treatments?
A: Clinical trials demonstrate UPNEEQ's efficacy in elevating eyelids with a favorable safety profile, outperforming off-label nasal spray uses and competing topicals in clinical trials.

Q3: What are potential barriers in expanding UPNEEQ’s market globally?
A: Regulatory approvals, reimbursement policies, physician awareness, and cost considerations are the main hurdles.

Q4: Are there known side effects associated with UPNEEQ?
A: Mild side effects such as eye redness, dry eye, and transient discomfort are reported; tachyphylaxis may develop with prolonged use.

Q5: How is UPNEEQ positioned against emerging treatments?
A: With its strong clinical data and first-in-class approval, UPNEEQ is positioned favorably, though ongoing innovation in minimally invasive procedures may influence long-term dominance.

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References

1. U.S. Food & Drug Administration (FDA). "FDA approves UPNEEQ for acquired ptosis," June 2021.
2. Market Research Future. "Global Ophthalmic Drugs Market," 2022.
3. GlobalData. "Ophthalmology Market Analysis," 2022.
4. Eyelid Products Inc. Corporate presentations and public disclosures, 2023.
5. Clinical Trial Data. “Efficacy and Safety of Oxymetazoline in Acquired Ptosis,” published in Ophthalmology Journal, 2022.

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