COMBIGAN Drug Patent Profile

Which patents cover Combigan, and what generic alternatives are available?

Combigan is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combigan

A generic version of COMBIGAN was approved as brimonidine tartrate; timolol maleate by SANDOZ on April 4^th, 2022.

Summary for COMBIGAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	22
Patent Applications:	109
Drug Prices:	Drug price information for COMBIGAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIGAN
What excipients (inactive ingredients) are in COMBIGAN?	COMBIGAN excipients list
DailyMed Link:	COMBIGAN at DailyMed

See drug prices for COMBIGAN

See drug sales revenues for COMBIGAN

Recent Clinical Trials for COMBIGAN

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

Sponsor	Phase
CHA University	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 4
Salus University	Phase 4

See all COMBIGAN clinical trials

Pharmacology for COMBIGAN

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for COMBIGAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIGAN	Ophthalmic Solution	brimonidine tartrate; timolol maleate	0.2%/0.5%	021398	1	2008-11-21

US Patents and Regulatory Information for COMBIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes

Expired US Patents for COMBIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	8,748,425
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	7,030,149
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	9,474,751
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	9,770,453

International Patents for COMBIGAN

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

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP034742	COMBINACION DE BRIMONIDINA Y TIMOLOL PARA USO OFTALMOLOGICO TOPICO
European Patent Office	3791109	LUMINAIRE À GUIDE DE LUMIÈRE SUSPENDU À ATTÉNUATION DU BRUIT (SUSPENDED PENDANT LIGHTGUIDE LUMINAIRE WITH SOUND DAMPENING)
Spain	2399045
European Patent Office	1496912	ASSOCIATION DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION OPHTALMOLOGIQUE TOPIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE)

Supplementary Protection Certificates for COMBIGAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221

Market Dynamics and Financial Trajectory for Combigan

Last updated: July 27, 2025

Introduction

Combigan, a topical ophthalmic solution combining brimonidine tartrate and timolol maleate, is prescribed primarily for lowering intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Introduced into the market by Allergan (now part of AbbVie), Combigan has established itself as a vital therapeutic option. Understanding its market dynamics and financial trajectory involves analyzing the drug's competitive landscape, regulatory status, and broader ophthalmology market trends.

Product Overview and Market Position

Combigan synergizes the mechanisms of brimonidine, an alpha-2 adrenergic agonist, and timolol, a non-selective beta-adrenergic blocker, offering dual-action efficacy in reducing IOP [1]. Its formulation offers patients a combination therapy, potentially reducing pill burden and improving adherence.

In terms of market positioning, Combigan primarily competes with other fixed-dose combinations (FDCs) such as Cosopt (dorzolamide/timolol) and Xalacom (latanoprost/timolol). Its efficacy, safety profile, and frequency of dosing influence its adoption rate among ophthalmologists and patients.

Market Dynamics

Global Ophthalmology Market Growth

The global glaucoma medications market is projected to grow at a compound annual growth rate (CAGR) of 4-6% during 2023-2030, driven by increasing prevalence of glaucoma, aging populations, and expanding healthcare infrastructure in emerging markets [2]. This growth directly benefits Combigan’s market potential, especially in regions with rising ophthalmic disease burden.

Prevalence and Demographics

The World Health Organization estimates that over 76 million people worldwide suffer from glaucoma, expected to reach 111 million by 2040 [3]. The aging demographic, particularly in North America, Europe, and parts of Asia, fosters sustained demand for intraocular pressure-lowering therapies like Combigan.

Competitive Landscape

Combigan faces competition from various monotherapies and other FDCs. Its key differentiators include its dual mechanism and tolerability. However, patents expiring in the past have led to the emergence of generic formulations, intensifying price competition. The approval and launch of novel agents, such as prostaglandin analogs and neuroprotective drugs, threaten its market share.

Regulatory and Patent Considerations

AbbVie’s patent protections for Combigan have historically provided market exclusivity, but patent cliffs have caused erosion of revenue streams, especially with generic versions entering the market post-2017. Steady regulatory approval in emerging markets enhances its reach but also exposes it to pricing pressures.

Manufacturing and Supply Chain Factors

The stability of supply chains and manufacturing capacity influences market availability and pricing. Recent global disruptions, like the COVID-19 pandemic, have caused fluctuations in supply, impacting sales volumes temporarily but underscoring the importance of resilient logistics strategies.

Financial Trajectory

Revenue Trends

AbbVie reported peak Combigan revenues prior to patent expiry, with estimates of approximately $250 million in 2015 [4]. Post-patent expiry, revenues declined due to generic competition, with current sales approximating $50–70 million annually.

Pricing Strategy and Market Penetration

Pricing strategies, influenced by regulatory and reimbursement policies, impact Combigan’s revenue. In developed markets like the U.S., insurance coverage and formulary listings determine access, while in emerging markets, lower price points facilitate wider adoption despite lower margins.

Impact of Generics and Biosimilars

Generic entry has truncated market profits for Combigan. The challenge lies in maintaining revenues through strategic positioning, including potential line extensions or formulation improvements. The launch of biosimilars or new combination drugs could further compress margins.

Future Growth Prospects

Long-term growth hinges on unmet clinical needs, such as therapies with fewer side effects or once-daily dosing. Partnering with regional distributors and extending patent protections via formulations or delivery systems may help prolong Combigan’s financial viability.

Research and Development (R&D) and Pipeline Influence

AbbVie’s R&D investments in glaucoma therapies may introduce alternatives to Combigan, potentially cannibalizing its market share but also opening avenues for new revenue streams.

Strategic Outlook

Considering current market trends, Combigan’s future profitability will depend on:

• Regulatory exclusivity in key markets.
• Market penetration in emerging economies.
• Innovation efforts to extend patent life or develop next-generation formulations.
• Competitive responses to emerging generic and biosimilar entrants.

Aggressive marketing, clinical evidence campaigns favoring combination therapy benefits, and partnerships with healthcare providers remain critical.

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Key Takeaways

• Combigan is a vital but declining player due to patent expiries and intense competition.
• The global growth of glaucoma prevalence supports ongoing demand, especially in aging populations.
• Revenue recovery relies heavily on regional market expansion, formulary placements, and innovation strategies.
• Price competition and generic erosion pose significant risks to profitability, incentivizing innovation or diversification.
• Long-term success depends on balancing R&D investments with market dynamics and regulatory strategies.

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FAQs

1. How has patent expiration affected Combigan’s market share?
Patent expiry has led to a surge in generic formulations, significantly reducing Combigan’s market share and revenue, pushing the original product to compete primarily on clinical efficacy and brand loyalty.

2. What are the main competitors to Combigan in the glaucoma treatment market?
Combigan's main competitors include fixed-dose combinations like Cosopt and Xalacom, along with monotherapies involving prostaglandin analogs, beta-blockers, and carbonic anhydrase inhibitors.

3. How are emerging markets influencing Combigan’s sales?
Expanding ophthalmology markets in Asia, Latin America, and Africa present growth opportunities due to rising glaucoma prevalence and increasing healthcare access, although price sensitivity necessitates affordable formulations.

4. What innovations could prolong Combigan’s market relevance?
Developing once-daily formulations, preservative-free options, or combining new agents with increased efficacy and tolerability could help sustain Combigan’s appeal.

5. What strategic moves can AbbVie pursue to sustain revenue from Combigan?
AbbVie could focus on patent extensions through new formulations, geographic expansion, strategic alliances, and investing in R&D for next-generation therapies.

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Sources

[1] "Combigan," Allergan, 2022.
[2] Global Ophthalmic Drugs Market Report, MarketsandMarkets, 2022.
[3] World Health Organization, "Global Data on Glaucoma," 2020.
[4] AbbVie Annual Report, 2015.