RESCULA Drug Patent Profile

When do Rescula patents expire, and when can generic versions of Rescula launch?

Rescula is a drug marketed by Sucampo Pharma Llc and is included in one NDA.

The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for RESCULA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1,283
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RESCULA
DailyMed Link:	RESCULA at DailyMed

Paragraph IV (Patent) Challenges for RESCULA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESCULA	Ophthalmic Solution	unoprostone isopropyl	0.15%	021214	1	2014-05-12

US Patents and Regulatory Information for RESCULA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000		DISCN	Yes	No

Expired US Patents for RESCULA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000

International Patents for RESCULA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20080012407
South Africa	8806909
New Zealand	521325	Use of prostaglandins for the treatment of ocular hypertension and glaucoma
Germany	68918391

Supplementary Protection Certificates for RESCULA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0289349	C300135	Netherlands		PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917
0289349	SPC/GB04/007	United Kingdom		PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112
0289349	300135	Netherlands		300135, 20080429, EXPIRES: 20130428

Market Dynamics and Financial Trajectory for RESCULA (Betaxolol Hydrochloride)

Last updated: July 27, 2025

Introduction

RESCULA (betaxolol hydrochloride) is a selective beta-1 adrenergic receptor blocker primarily used in managing glaucoma and ocular hypertension.[1] Since its initial approval, the drug has experienced evolving market dynamics driven by clinical practices, technological advancements, and regulatory policies. Analyzing its current and future financial trajectory necessitates understanding the key market factors influencing its demand, competition landscape, regulatory environment, and therapeutic positioning.

Market Overview

Therapeutic Area and Clinical Usage

RESCULA is indicated for reducing intraocular pressure (IOP) in glaucoma and ocular hypertension.[1] The global prevalence of glaucoma exceeds 76 million, with projections reaching over 112 million by 2040, according to the World Glaucoma Association.[2] This expanding patient population underscores the sustained need for IOP-lowering agents like RESCULA.

Patronage in Ophthalmology

Ophthalmologists favor beta-blockers for initial glaucoma therapy due to well-established efficacy, safety profiles, and affordability.[3] However, the emergence of combination therapies and the advent of novel drug classes (e.g., prostaglandin analogs) influence market share dynamics.

Manufacturing and Patent Landscape

As of now, RESCULA's patent exclusivity has largely expired in several jurisdictions, exposing it to generic competition. This shift typically affects pricing strategies, sales volume, and profit margins.

Market Dynamics Influencing RESCULA

1. Competitive Landscape

The ophthalmic market for glaucoma medications features numerous alternatives, including prostaglandin analogs (latanoprost, travoprost), alpha-adrenergic agonists, and carbonic anhydrase inhibitors.

Impact:
Generic formulations of betaxolol have increased price competition, pressuring revenue streams. Yet, RESCULA retains market relevance in specific segments due to established safety and familiarity among clinicians.[4]

2. Regulatory and Reimbursement Policies

Regulatory bodies in major markets (FDA, EMA) enforce strict prescribing guidelines, often favoring newer, branded agents due to perceived improved efficacy or convenience. Reimbursement policies increasingly favor cost-effective treatments, putting pressure on older drugs like RESCULA to demonstrate value.

Impact:
Cost considerations have limited the growth potential of RESCULA, especially in regions transitioning towards value-based care models.

3. Technological Innovations

Advances such as sustained-release drug delivery systems, minimally invasive surgical procedures, and alternative prostaglandin formulations are reshaping glaucoma management.

Impact:
The adoption of innovative therapies may diminish long-term reliance on traditional formulations like RESCULA, influencing its market share trajectory.

4. Patient and Prescriber Preferences

Shifts toward medications with fewer dosing requirements, better tolerability, and reduced systemic effects affect drug selection.

Impact:
RESCULA's once or twice-daily dosing regimen remains convenient, but newer agents offering sustained-release or fewer side effects may gain prominence.

Financial Trajectory

Revenue Trends

While exact sales data are proprietary and fragmented, industry estimates suggest a downward trend in RESCULA’s revenue in mature markets, primarily due to generic competition.[5] However, in emerging markets with limited access to newer drugs, sales sustain a modest growth trajectory.

Pricing Strategy and Profitability

Generic availability has exerted downward pressure on pricing. Manufacturers may employ strategies such as bundling, branding retention in select regions, or formulation improvements to preserve margins.

Market Penetration and Expansion

Rescue markets in developing regions—such as parts of Asia, Africa, and Latin America—offer growth opportunities. However, infrastructural barriers and limited healthcare funding restrict rapid expansion.

Long-term Outlook

The cumulative impact of generic competition, evolving therapeutics, and regulatory constraints suggests a gradual decline in RESCULA’s market dominance in developed markets. Strategic repositioning, such as combination therapies or formulation innovation, could temporarily bolster its financial prospects.

Strategic Considerations

Diversification and Line Extensions

The pharmaceutical entities managing RESCULA might explore formulation innovations—sustained-release systems or combination products—to extend lifecycle and market relevance.

Entry into Adjacent Markets

Expanding indications, such as systemic hypertension, could open new revenue streams, albeit with significant clinical and regulatory hurdles.

Cost Optimization and Partnerships

Partnering with local manufacturers in emerging markets enables cost-effective distribution, addressing the price sensitivity of these segments.

Conclusion

RESCULA’s market remains stable but faces transitional challenges typical of branded ophthalmic drugs encountering generic competition. Its future financial trajectory hinges on strategic adaptations—such as innovative formulations, geographic expansion, and positioning within combination therapies—to offset declining sales in mature markets.

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Key Takeaways

• Market decline is imminent: Generic competition significantly erodes RESCULA’s pricing power and sales volume in developed markets.
• Opportunities in emerging regions: Untapped markets with limited access to newer therapies provide potential growth avenues.
• Innovation is vital: Formulation advancements and combination approaches can extend RESCULA’s lifecycle.
• Regulatory and reimbursement policies are pivotal: They influence prescriber preferences and market viability.
• Diversification is essential: Expanding indications or developing related formulations can mitigate revenue decline.

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FAQs

1. What factors have primarily contributed to the decline of RESCULA in the global market?
The expiry of patents and subsequent generic entry has led to price competition, reducing profit margins and sales volume. Additionally, the rise of newer glaucoma therapies offers alternatives that are often perceived as more convenient or effective.

2. Can RESCULA’s market share be effectively preserved through innovation?
Yes. Developing sustained-release formulations, fixed-dose combinations, or expanding indications can rejuvenate its market presence and offset decline caused by generics.

3. How does REGULATORY policy affect RESCULA’s market future?
Regulations influencing drug registration, reimbursement, and prescribing guidelines can either limit or facilitate usage. Policies favoring newer, reimbursable drugs may accelerate RESCULA’s market share decline.

4. Are there regional differences in RESCULA’s market prospects?
Absolutely. Developed markets exhibit accelerated decline due to competition, while regions with limited access to newer drugs present growth opportunities, especially where affordability is a key factor.

5. What strategic steps should manufacturers consider for RESCULA’s longevity?
Focus on formulation innovation, explore combination therapies, expand into underserved markets, and actively manage regulatory pathways to sustain revenue streams.

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References

[1] Rescula (betaxolol hydrochloride) official prescribing information.
[2] World Glaucoma Association. “Global prevalence of glaucoma,” 2020.
[3] Weinreb, R. N., et al. “Guidelines for glaucoma management,” Ophthalmology, 2016.
[4] Market intelligence reports, GlobalData, 2022.
[5] Company financial disclosures and industry estimates, 2022.