TRUSOPT Drug Patent Profile

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

Trusopt is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in TRUSOPT is dorzolamide hydrochloride. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trusopt

A generic version of TRUSOPT was approved as dorzolamide hydrochloride by RUBICON RESEARCH on October 28^th, 2008.

Summary for TRUSOPT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	5,404
Drug Prices:	Drug price information for TRUSOPT
What excipients (inactive ingredients) are in TRUSOPT?	TRUSOPT excipients list
DailyMed Link:	TRUSOPT at DailyMed

See drug prices for TRUSOPT

See drug sales revenues for TRUSOPT

Recent Clinical Trials for TRUSOPT

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

Sponsor	Phase
National Eye Institute (NEI)	Phase 3
University of Miami	Phase 3
National Eye Institute (NEI)	Phase 1/Phase 2

See all TRUSOPT clinical trials

Paragraph IV (Patent) Challenges for TRUSOPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUSOPT	Ophthalmic Solution	dorzolamide hydrochloride	2%	020408	1	2005-10-11

US Patents and Regulatory Information for TRUSOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994		DISCN	Yes	No

Expired US Patents for TRUSOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994

International Patents for TRUSOPT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0189690	SUBSTITUTED AROMATIC SULFONAMIDES, THEIR PREPARATION AND OPHTHALMIC COMPOSITIONS CONTAINING THEM
Germany	3170818
Netherlands	191879
Denmark	167874

Supplementary Protection Certificates for TRUSOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	C990041	Netherlands		PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0509752	SPC/GB99/043	United Kingdom		PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
0296879	96C0003	Belgium		PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219

Market Dynamics and Financial Trajectory for TRUSOPT (Dorzolamide Hydrochloride)

Last updated: August 3, 2025

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Introduction

TRUSOPT (dorzolamide hydrochloride) is a topical carbonic anhydrase inhibitor primarily prescribed for reducing intraocular pressure in patients with glaucoma and ocular hypertension. Since its FDA approval in 1995, TRUSOPT has maintained a significant position within the ophthalmic therapeutics market, characterized by evolving market dynamics, competitive forces, and shifting reimbursement landscapes. This analysis examines the current market environment, assesses the financial trajectory, and explores future growth prospects for TRUSOPT.

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Market Overview and Key Drivers

Global Ophthalmic Disease Burden

The rising prevalence of glaucoma, projected to affect over 80 million individuals globally by 2020, underscores the ongoing demand for effective intraocular pressure-lowering agents like TRUSOPT [1]. Aging populations across North America, Europe, and Asia-Pacific regions further amplify the need for chronic glaucoma management.

Doctor and Patient Preferences

Despite availability of various therapeutic options, fixed-dose combination therapies and novel agents have emerged, influencing prescribing patterns. Nevertheless, TRUSOPT’s affordability, efficacy, and established safety profile sustain its relevance in routine ophthalmic care.

Regulatory and Patent Landscape

TRUSOPT’s patent expiry in various markets has catalyzed generic penetration, intensifying price competition. Nonetheless, manufacturers continue to defend their market share via formulation improvements and combination therapies, maintaining revenue streams.

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Market Dynamics

Competitive Environment

TRUSOPT faces competition primarily from other carbonic anhydrase inhibitors, such as brinzolamide (AZOPT) and brimonidine. Fixed-dose combinations, including dorzolamide-timolol, have gained popularity owing to convenience and enhanced adherence, potentially cannibalizing TRUSOPT sales.

Generic Entry and Pricing Impact

The introduction of generic dorzolamide hydrochloride in key markets around 2015 significantly reduced costs, pressuring brand-name sales. According to IQVIA data, generic formulations account for over 85% of ophthalmic glaucoma drug prescriptions in the U.S., markedly decreasing TRUSOPT’s revenue contribution [2].

Reimbursement and Market Access

Reimbursement policies increasingly favor generics. Payers’ emphasis on cost-effective treatments incentivizes switching from branded TRUSOPT to generic equivalents, impacting the financial trajectory of branded formulations.

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Financial Trajectory Analysis

Historical Performance

Since patent expiration, TRUSOPT’s sales have declined substantially. Sanofi, the original manufacturer, reported a sharp revenue drop as generics penetrated the market; a similar trend is observed in ongoing market reports [3].

Current Revenue Streams

While major revenue erosion persists, TRUSOPT remains commercially relevant in emerging markets and in formulations combining it with other agents. Additionally, its role as a foundational therapy sustains a baseline revenue, particularly where affordability remains a priority.

Future Sales Projections

Forecasts estimate continued decline in TRUSOPT’s standalone sales in mature markets over the next five years due to generics and fixed-dose combinations. However, niche markets, improved formulations, and regional markets with delayed generic adoption could buffer declines.

• Emerging Markets: Growing glaucoma prevalence offers sales opportunities, supported by expanding healthcare infrastructure.
• Formulation Innovations: Development of preservative-free or combination options could rejuvenate interest and sustain sales.
• Market Penetration Strategies: Strategic partnerships and localized marketing are critical in maintaining relevance.

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Strategic Growth Opportunities

Combination Therapies

Fixed-dose combinations involving dorzolamide—such as dorzolamide-timolol—have demonstrated superior efficacy and adherence benefits, often surpassing monotherapies in market share. These formulations are likely to displace standalone TRUSOPT sales but may also present new branding and revenue opportunities.

Regulatory Approvals and New Indications

Seeking approval for novel formulations (e.g., preservative-free or sustained-release variants) and exploring additional indications, such as in neurological or systemic indications, could diversify revenue streams.

Digital and Patient-Centric Approaches

Leveraging digital health initiatives to improve patient adherence and monitoring could indirectly bolster TRUSOPT’s usage, especially in chronic management settings.

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Risks and Challenges

• Pricing Pressure: Continued erosion from generics exerts downward pricing pressures.
• Market Penetration: Competition from alternative therapies and fixed-dose combinations reduces TRUSOPT’s market share.
• Regulatory Hurdles: Approval delays and regulatory constraints for new formulations can impede growth.
• Patent and IP Issues: Risk of patent challenges in certain jurisdictions might impact exclusivity and pricing strategies.

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Concluding Remarks

TRUSOPT’s market dynamics are shaped by a mature, highly competitive environment marked by the proliferation of generics and combination therapies. While the pharmaceutical’s revenue trajectory faces downward pressure, regional growth prospects, formulation innovations, and strategic repositioning offer potential avenues for stabilization or niche expansion. Companies leveraging these factors, coupled with an emphasis on affordability and patient adherence, are positioned to optimize TRUSOPT’s market viability over the coming years.

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Key Takeaways

• Market decline persists due to patent expiry, generic competition, and preference for fixed-dose combinations.
• Emerging markets present significant growth opportunities driven by rising glaucoma prevalence.
• Innovations in formulations and regulatory strategies may prolong TRUSOPT’s relevance.
• Partnerships and regional adaptation are crucial for maintaining revenue streams.
• Focus on patient adherence and cost-effective therapies sustains brand value in a competitive landscape.

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FAQs

1. What is the primary therapeutic use of TRUSOPT?
TRUSOPT (dorzolamide hydrochloride) is used to lower intraocular pressure in patients with glaucoma and ocular hypertension.

2. How has patent expiry affected TRUSOPT’s market share?
Patent expiration led to widespread generic entry, significantly reducing brand-name sales and intensifying price competition.

3. Are there ongoing developments to improve TRUSOPT formulations?
Yes. Efforts include developing preservative-free versions and fixed-dose combinations to enhance adherence and efficacy.

4. Which regions offer the most growth opportunities for TRUSOPT?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa present higher growth potential due to rising disease prevalence and expanding healthcare access.

5. How can pharmaceutical companies sustain revenues related to TRUSOPT?
By developing novel formulations, expanding into untapped regional markets, forming strategic alliances, and integrating digital health initiatives aimed at improving patient adherence.

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References

[1] Quigley, H. A., & Broman, A. T. (2006). The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol, 90(3), 262–267.

[2] IQVIA. (2022). Pharmaceutical Market Data and Prescription Insights.

[3] Sanofi Annual Report. (2020). Financial and Market Performance Overview.