COMBIGAN Drug Patent Profile

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

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. Twelve 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:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	22
Patent Applications:	82
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
Hanlim Pharm. Co., Ltd.	Phase 4
CHA University	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
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007

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
South Korea	20040100844
New Zealand	528945	Combination of brimonidine and timolol for topical ophthalmic use for the treatment of glaucoma and intraocular pressure

Supplementary Protection Certificates for COMBIGAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300683	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

Market Dynamics and Financial Trajectory for COMBIGAN

Last updated: February 19, 2026

What Are the Key Market Drivers for COMBIGAN?

COMBIGAN is a fixed-dose combination of brimonidine tartrate (0.2%) and timolol maleate (0.5%) approved for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The drug's market growth depends on several factors:

• Prevalence of Glaucoma: Global cases exceed 76 million, projected to reach 111 million by 2040 [1]. The rising prevalence drives demand.

• Standard of Care Shift: There is a shift towards combination therapies over monotherapies to improve adherence and efficacy.

• Competitive Landscape: COMBIGAN faces competition from other fixed-dose combinations such as Cosopt (dorzolamide/timolol) and notable generics.

• Approval and Reimbursement Policies: Regulatory approval in key markets (US, Europe, Asia) and inclusion in reimbursement schemes influence market penetration.

• Patient Preference: Simplicity of dosing (one drop) enhances adherence—critical in chronic diseases like glaucoma.

• Market Awareness and Physician Adoption: Education campaigns and clinical guidelines influence prescribing patterns.

How Does the Competitive Environment Impact COMBIGAN’s Market Share?

COMBIGAN's primary competitors include:

• Cosopt: Combines dorzolamide and timolol. Available as brand and generics; longer market presence.

• Simbrinza: Combines brinzolamide and brimonidine. Targets patients intolerant to beta-blockers.

• Other Fixed Combinations: Numerous formulations with varying efficacy profiles and pricing.

Market share tends to favor drugs with established safety profiles, broader insurance coverage, and lower costs. As generics enter the market, COMBIGAN faces pressure on pricing and sales volume.

What Are the Financial Projections for COMBIGAN?

Financial performance relies on prescribing trends, pricing strategies, and market expansion:

Year	Estimated Global Sales (USD Million)	Comments
2022	300	Steady growth driven by increasing glaucoma prevalence
2023	350	Adoption accelerates with expanded reimbursement
2024	400-450	Entry into new markets, including Asia-Pacific
2025+	500+	Market saturation, potential impact from generics

Data indicates a compound annual growth rate (CAGR) of approximately 15% from 2022 to 2025. Pricing strategies, regional expansion, and future patent status will influence these figures.

What Are the Patent and Regulatory Risks?

COMBIGAN's patent protections vary by jurisdiction:

• US Patent Expiry: Typically around 2024–2026. Patent cliffs could lead to increased generic competition.

• Europe: Patent expiry similar to the US, with additional regulatory hurdles influencing market entry.

• Regulatory Approvals: Ongoing approvals or new indications influence the drug’s lifecycle. Any delays could hamper revenue growth.

Manufacturers may pursue formulation patents or supplementary indications to prolong exclusivity.

How Do Pharmacoeconomic Trends Affect COMBIGAN?

Costs and value-based healthcare models impact COMBIGAN’s adoption:

• Cost-Effectiveness: Fixed-dose combinations improve adherence, reduce side effects, and decrease overall treatment costs.

• Insurance/Reimbursement: Coverage levels influence out-of-pocket costs and prescribing behavior.

• Market Entry of Generics: Lower-cost alternatives could erode profit margins, shifting focus toward volume.

What Is the Future Outlook?

Market expansion hinges on capturing emerging markets, regulatory approvals, and innovations such as sustained-release formulations:

• Emerging Markets: Growing healthcare infrastructure and awareness foster adoption.

• Formulation Innovation: Extended-release versions could improve adherence further.

• Pipeline Products: Competitors developing novel therapies or combination drugs may influence long-term prospects.

The setback of patent expirations emphasizes the importance of pipeline development and market differentiation strategies.

Key Takeaways

• Global glaucoma prevalence drives COMBIGAN market demand.
• Competition from generics and established fixed-dose combinations pressures pricing and market share.
• Financial projections suggest mid-teens CAGR via 2025, contingent on regulatory and reimbursement landscapes.
• Patent expiry risks threaten near-term exclusivity, prompting focus on lifecycle management.
• Uptake in emerging markets and formulation innovations present growth opportunities.

FAQs

Q1: What is COMBIGAN’s primary advantage over monotherapy?
Fixes dosing complexity, improves patient adherence, and maintains efficacy by combining two agents with complementary mechanisms.

Q2: When is COMBIGAN expected to face patent expiry?
Patent protections in the US and Europe are nearing expiration between 2024 and 2026, increasing generic competition.

Q3: How does pricing compare to competitors?
Price varies regionally; COMBIGAN’s cost is generally higher than generics but remains competitive against other brand combinations, factoring in compliance benefits.

Q4: What are key markets for growth?
North America, Europe, and Asia-Pacific show substantial potential, driven by increasing glaucoma prevalence and improving healthcare access.

Q5: What strategic actions can sustain COMBIGAN’s market position?
Developing new formulations, expanding into underserved markets, and securing new indications will help mitigate patent risks and maintain revenue.

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References

[1] Bourne, R. R. A., et al. (2017). Global prevalence of glaucoma and projections of glaucoma burden for 2010–2040. Ophthalmology, 124(6), 766-776.