DORZOLAMIDE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for dorzolamide hydrochloride and what is the scope of patent protection?

Dorzolamide hydrochloride is the generic ingredient in five branded drugs marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland, Hikma, Micro Labs, Regcon Holdings, Rubicon Research, Sandoz, Somerset Theraps Llc, Teva Pharms, Zambon Spa, Msd Sub Merck, Thea Pharma, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, New Heightsrx, and Somerset, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for dorzolamide hydrochloride. Fourteen suppliers are listed for this compound.

Summary for DORZOLAMIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	21
NDAs:	37
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	57
Patent Applications:	735
What excipients (inactive ingredients) are in DORZOLAMIDE HYDROCHLORIDE?	DORZOLAMIDE HYDROCHLORIDE excipients list
DailyMed Link:	DORZOLAMIDE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DORZOLAMIDE HYDROCHLORIDE

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

Sponsor	Phase
CT Glaucoma Associates	PHASE4
Laboratorios Poen	Phase 4
Shahid Beheshti University of Medical Sciences	Phase 2/Phase 3

See all DORZOLAMIDE HYDROCHLORIDE clinical trials

Pharmacology for DORZOLAMIDE HYDROCHLORIDE

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DORZOLAMIDE HYDROCHLORIDE

S01EC	Carbonic anhydrase inhibitors
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE

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 DORZOLAMIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset Theraps Llc	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	215004-001	Feb 11, 2025	AT	RX	No	No
Thea Pharma	COSOPT PF	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	202667-001	Feb 1, 2012	AT2	RX	Yes	Yes
Alembic	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	213099-001	May 4, 2021	AT1	RX	No	No

Expired US Patents for DORZOLAMIDE HYDROCHLORIDE

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	4,619,939*PED
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994	4,797,413*PED

Market Dynamics and Financial Trajectory for Dorzolamide Hydrochloride

Last updated: October 15, 2025

Overview

Dorzolamide Hydrochloride is a topical carbonic anhydrase inhibitor primarily employed in the management of glaucoma and ocular hypertension. Approved by the U.S. Food and Drug Administration (FDA) in 1995, it has established itself as a critical component of ocular hypotensive therapy. Its pharmacological profile, efficacy, and safety record position it firmly within a competitive landscape characterized by innovative therapies and regional market variances.

This analysis explores the evolving market dynamics, competitive landscape, regulatory considerations, and projected financial trajectory for Dorzolamide Hydrochloride, aimed at informing stakeholders ranging from pharmaceutical companies to investors.

Market Landscape and Epidemiological Drivers

The global glaucoma treatment market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% through 2030 [1]. The increasing prevalence of glaucoma, projected to affect over 110 million people worldwide by 2030 [2], significantly influences the demand for Dorzolamide Hydrochloride and similar medications.

Age-related ocular conditions dominate the indications for Dorzolamide Hydrochloride, with the aging global population driving market growth. Developed markets such as North America and Europe exhibit higher adoption rates, often tied to established healthcare infrastructure and reimbursement parameters. Conversely, emerging markets present substantial growth opportunities due to increasing ophthalmic healthcare access.

Competitive Positioning and Market Share

Dorzolamide Hydrochloride's primary competitors include alternative carbonic anhydrase inhibitors such as brinzolamide, and combination drugs like dorzolamide/timolol. Generics entered the market following patent expirations, intensifying price competition and expanding accessibility [3].

Key Players:

• Novartis (original manufacturer with Glaupax)
• Akorn Pharmaceuticals (generic supplier)
• Santen Pharmaceutical (regional formulations)
• Others: Alcon, Sun Pharmaceutical Industries

Market share distribution largely hinges on patent exclusivity, regional regulatory approvals, and brand loyalty. In the U.S., the generic versions now account for over 70% of prescriptions, exerting downward pressure on prices.

Regulatory and Patent Landscape

The patent expiration of original formulations has catalyzed a proliferation of generics, fostering price competition. Regulatory harmonization continues across developing markets, facilitated by initiatives such as the WHO's prequalification program, opening new avenues for affordable formulations.

Notably, tighter regulatory scrutiny around compounded formulations and biosimilars may influence future market accessibility and innovation strategies. Ongoing clinical trials examining combination therapies and new delivery systems may extend the therapeutic utility of Dorzolamide Hydrochloride or replace it with more advanced options.

Pricing Trends and Reimbursement Policies

Pricing for Dorzolamide Hydrochloride has declined sharply following patent expiry and generic entry. In the U.S., the average retail price for a 30-day supply of branded Dorzolamide Hydrochloride hovers around USD 130–150, while generics reduce this to approximately USD 50–70 [4].

Reimbursement frameworks favor cost-effective treatments; Medicare and Medicaid policies in the U.S. and national health schemes elsewhere influence prescribing patterns. Value-based pricing models and formulary restrictions are increasingly applied to ocular hypotensive agents, impacting the financial trajectory.

R&D Investment and Innovation

Most R&D efforts focus on combination formulations (e.g., dorzolamide/timolol) to enhance compliance and therapeutic efficacy. Novel delivery mechanisms such as sustained-release implants are under investigation, aiming to improve patient adherence and reduce treatment burden.

While proprietary formulations underpin revenue streams, the commoditization of Dorzolamide Hydrochloride through generics constrains incremental innovation. Nonetheless, strategic collaborations and lifecycle management through new formulations could present revenue opportunities.

Financial Outlook and Growth Projections

Given the mature nature of Dorzolamide Hydrochloride, revenue growth will primarily be driven by volume increases rather than price enhancements. The expanding global glaucoma population and heightened awareness contribute positively.

Market forecasts suggest annual sales in excess of USD 300 million in established markets, with potential for growth in emerging economies. The transition to generic dominance may lead to revenue margins compressing over the next five years, although volume gains could offset this trend.

Potential Revenue Streams:

• Existing formulations in mature markets
• Entry into emerging markets via partnerships
• Development of combination therapies and new delivery platforms

Challenges and Risks

• Regulatory shifts: Stricter regulations could limit market access or introduce new compliance costs.
• Patent litigation: Vigilance on patent challenges and exclusivity periods remains critical.
• Market saturation: High generic penetration limits premium pricing opportunities.
• Competitive innovations: Emergence of novel drugs with superior efficacy or delivery may threaten dorzolamide’s market share.

Opportunities for Stakeholders

• Product Differentiation: Clinical differentiation through combination therapies and new delivery systems.
• Market Expansion: Increasing ophthalmic healthcare infrastructure in emerging economies.
• Pricing Strategies: Adoption of tiered pricing to navigate global reimbursement landscapes.
• Lifecycle Management: Developing next-generation formulations or biosimilars.

Key Takeaways

• The Dorzolamide Hydrochloride market is characterized by a mature product lifecycle, with limited scope for significant price growth amid intense generic competition.
• Growing global burden of glaucoma and ocular hypertension sustains demand; however, revenue growth is predominantly volume-driven.
• Regional disparities, regulatory environments, and reimbursement policies significantly influence market dynamics.
• Investment in innovative delivery systems and combination therapies remains essential for sustaining revenue streams.
• Strategic collaborations and market expansion into emerging economies offer viable pathways for revenue diversification.

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FAQs

1. What factors are driving the global demand for Dorzolamide Hydrochloride?
The rising prevalence of glaucoma and ocular hypertension, combined with an aging population and increasing healthcare access, drives demand. Additionally, the drug's proven efficacy and safety sustain its role in glaucoma management.

2. How has patent expiration impacted Dorzolamide Hydrochloride's market?
Patent expiry has resulted in widespread availability of generics, reducing prices and compressing margins. While volumes increase due to affordability, revenues from branded formulations decline.

3. What are the main competitors to Dorzolamide Hydrochloride?
Key competitors include alternative carbonic anhydrase inhibitors like brinzolamide, various combination therapies such as dorzolamide/timolol, and emerging biologic or novel delivery-based treatments.

4. Which regions offer the most growth opportunities for Dorzolamide Hydrochloride?
Emerging markets in Asia, Latin America, and Africa present significant opportunities owing to expanding healthcare infrastructure, increasing disease prevalence, and lower market penetration of branded therapies.

5. What future innovations could influence Dorzolamide Hydrochloride's market?
Development of sustained-release ocular implants, fixed-dose combination therapies, and biosimilars could reshape the competitive landscape and extend product utility.

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References

[1] MarketWatch. (2022). Glaucoma Medications Market Size, Share & Trends.
[2] Tham, Y.C., et al. (2014). Global prevalence of glaucoma and projections of glaucoma burden through 2040: A systematic review and meta-analysis. Ophthalmology, 121(11), 2081–2090.
[3] Statista. (2022). Revenue from generic pharmaceuticals globally.
[4] GoodRx. (2023). Cost of Dorzolamide Hydrochloride in the United States.