Dorzolamide hydrochloride; timolol maleate - Generic Drug Details

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

Dorzolamide hydrochloride; timolol maleate is the generic ingredient in three branded drugs marketed by Thea Pharma, Alembic, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Hikma, Ingenus Pharms Llc, Micro Labs, New Heightsrx, Regcon Holdings, Rubicon Research, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for dorzolamide hydrochloride; timolol maleate

US Patents:	0
Tradenames:	3
Applicants:	18
NDAs:	22
Finished Product Suppliers / Packagers:	17
Clinical Trials:	9
DailyMed Link:	dorzolamide hydrochloride; timolol maleate at DailyMed

Recent Clinical Trials for dorzolamide hydrochloride; timolol maleate

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

Sponsor	Phase
University of Florida	Phase 1
Allergan	Phase 3
Meir Medical Center	N/A

See all dorzolamide hydrochloride; timolol maleate clinical trials

Pharmacology for dorzolamide hydrochloride; timolol maleate

Drug Class	Carbonic Anhydrase Inhibitor beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dorzolamide hydrochloride; timolol maleate

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COSOPT	Ophthalmic Solution	dorzolamide hydrochloride; timolol maleate	2%/0.5%	020869	1	2005-10-11

US Patents and Regulatory Information for dorzolamide hydrochloride; timolol maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	207523-001	Jun 25, 2019	AT1	RX	No	No
Rubicon Research	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	078201-001	Oct 28, 2008		DISCN	No	No
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	AT1	RX	Yes	Yes
Gland	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215520-001	Sep 19, 2022	AT1	RX	No	No
Sandoz	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	078749-001	Nov 6, 2008	AT1	RX	No	No
Micro Labs	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	204777-001	May 28, 2020	AT1	RX	No	No

Expired US Patents for dorzolamide hydrochloride; timolol maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998

Market Dynamics and Financial Trajectory for Dorzolamide Hydrochloride; Timolol Maleate

Last updated: July 28, 2025

Introduction

Dorzolamide Hydrochloride with Timolol Maleate represents a combination ophthalmic therapy principally used for managing glaucoma and ocular hypertension. As a fixed-dose formulation, it combines carbonic anhydrase inhibition with beta-blocker activity, aimed at reducing intraocular pressure (IOP). Understanding market dynamics and financial trajectories for this drug provides critical insights for stakeholders, including pharmaceutical manufacturers, investors, and healthcare policymakers.

Market Landscape

Global Prevalence and Urgency

Glaucoma affects over 76 million globally, projected to reach 111 million by 2040, with primary open-angle glaucoma (POAG) constituting the majority cases ([1]). Elevated IOP remains the only modifiable risk factor. The rising prevalence directly fuels demand for effective IOP-lowering medications like dorzolamide-timolol combo.

Key Players and Patent Status

Major pharmaceutical firms, including Novartis (brand Trusopt for dorzolamide) and Merck (brand Timoptic for timolol), dominate initial markets. The fixed-dose combination (FDC) formulations entered later, with authorized patent protections or exclusivity periods extending until around 2025–2030 ([2]). Patent expiries open commercial opportunities for generic manufacturers, intensifying market competition.

Regulatory Environment

Globally, regulatory approvals hinge on demonstrating safety and efficacy—under the auspices of agencies such as the FDA, EMA, and local health authorities. The approval landscape influences market access timelines and potential revenue streams.

Market Penetration and Adoption Dynamics

Physician preference, patient adherence, and side effect profiles shape adoption rates. Fixed-dose combinations improve compliance over multiple separate medications, favoring market penetration but face hurdles regarding clinician familiarity and cost perceptions.

Emerging Therapies and Competitive Pressures

New classes, including prostaglandin analogs and rho kinase inhibitors, threaten to displace traditional beta-blocker and carbonic anhydrase inhibitor monotherapies and combinations. The pipeline of novel ocular hypotensives may influence future market size and segmentation dynamics.

Financial Trajectory Analysis

Revenue Generation

Historically, the combination’s revenue growth correlates with the global glaucoma drug market, which is estimated to reach USD 5.5 billion by 2026, growing at a CAGR of approximately 4% ([3]). Fixed-dose combinations are garnering increased preference, leading to improved margins for innovator and generic firms.

Pricing Dynamics and Reimbursement

Pricing strategies vary by region; developed markets favor premium pricing for branded formulations, while generics drive down costs, boosting access. Reimbursement policies critically affect profitability—expensive branded FDCs benefit from favorable reimbursement in markets like the US, while price pressure in emerging economies hampers margins.

Patent Expiry and Generic Competition

Patent expiration around the late 2020s could catalyze a surge in generic entrants, drastically reducing prices and profit margins. Companies with early generic positioning can capture substantial market share, creating lucrative short-to-mid term revenue streams before a potential market saturation.

Market Expansion Opportunities

Untapped markets, particularly in Asia-Pacific, Africa, and Latin America, offer significant growth potential due to expanding healthcare infrastructure and increasing disease awareness. Strategic licensing or direct product launches could enhance revenue streams.

Portfolio Diversification and R&D Investment

Firms investing in novel fixed-dose combinations or alternative delivery systems—such as sustained-release implants or nanoparticle formulations—aim to offset declining revenues from traditional therapies, shaping long-term financial trajectories.

Market and Financial Outlook Summary

The combination of dorzolamide hydrochloride and timolol maleate remains a cornerstone in glaucoma therapy, with sustained demand driven by the rising glaucoma burden. Patent protections and regional regulatory considerations influence sales potential. The impending patent cliff and rapid generics proliferation prompt strategic repositioning, including portfolio diversification and pipeline investments. The overall financial trajectory, while strong in the short to medium term, faces evolving competition and pricing pressures.

Key Takeaways

• Growing Globe Burden: Increasing prevalence of glaucoma ensures sustained demand for dorzolamide-timolol combination therapies.
• Patent and Competition Dynamics: Patent expiries and generic entrants are primary drivers of pricing and revenue changes, requiring proactive market strategies.
• Regional Market Variability: Economic development, regulatory environments, and healthcare infrastructure heavily influence market growth opportunities.
• Pipeline and Innovation: Investments in novel formulations and delivery systems are vital for maintaining competitive advantage amidst rising generic competition.
• Market Expansion Focus: Targeting emerging markets presents significant revenue potential given rising disease awareness and increasing healthcare investment.

FAQs

Q1: What factors influence the adoption of dorzolamide-timolol fixed-dose combination therapy?
A1: Physician prescribing habits, patient adherence, side effect profile, cost, and regulatory approval determine adoption rates. Fixed-dose combinations improve compliance, favoring their use amid these factors.

Q2: How does patent expiration impact the market for dorzolamide-timolol?
A2: Patent expiration enables generic competition, leading to price reductions, increased accessibility, and potentially declining revenues for branded formulations but creating opportunities for generics and biosimilars.

Q3: What are the main challenges faced by pharmaceutical companies in maintaining profitability?
A3: Patent cliffs, pricing pressures in regulated markets, evolving treatment paradigms, and emerging therapies challenge profitability. Strategic investments in R&D and market expansion are essential.

Q4: Which emerging therapies could disrupt the current market for glaucoma medications?
A4: Prostaglandin analogs, rho kinase inhibitors, and sustained-release implants are promising alternatives that may reduce reliance on traditional FDCs.

Q5: How significant are regional differences in shaping market dynamics?
A5: Regional disparities in economic capacity, healthcare infrastructure, and regulatory frameworks influence market entry, pricing, and adoption, substantially affecting overall market growth and profitability.

References

1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262-7.
2. U.S. Food and Drug Administration. Patent and exclusivity information for ophthalmic drugs.
3. Grand View Research. Glaucoma Drugs Market Size, Share & Trends Analysis Report.

---

Note: This synthesized analysis offers a strategic overview of market and financial considerations relevant to dorzolamide hydrochloride and timolol maleate. For precise investment or clinical decisions, consult comprehensive market reports and regulatory updates.