COMBIGAN Drug Patent Profile

Which patents cover Combigan, 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. Thirteen 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIGAN

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

International Patents for COMBIGAN

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA03008401	COMBINACION DE BRIMONIDINA Y TIMOLOL PARA USO OFTALMICO, TOPICO. (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE.)
Taiwan	200402296	Combination of brimonidine and timolol for topical ophthalmic use
Australia	2003228480	COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE
European Patent Office	1496912	ASSOCIATION DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION OPHTALMOLOGIQUE TOPIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE)
China	101664414	Combination of brimonidine and timolol for topical ophthalmic use
Norway	20044450
Portugal	1496912

Supplementary Protection Certificates for COMBIGAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221

Investment Scenario and Fundamentals Analysis for COMBIGAN

Last updated: February 20, 2026

What is COMBIGAN?

COMBIGAN is a combination ophthalmic medication containing brimonidine tartrate (0.2%) and timolol maleate (0.5%). It is approved by the U.S. Food and Drug Administration (FDA) for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Marketed primarily by Allergan, now part of AbbVie, COMBIGAN offers a dual mechanism of action targeting aqueous humor production.

Market Overview

Glaucoma Treatment Landscape

• The global glaucoma medications market was valued at approximately USD 4.2 billion in 2021.
• Projected Compound Annual Growth Rate (CAGR): 6.4% (2022-2027).
• Main therapies include prostaglandin analogs, beta-blockers, alpha-adrenergic agonists, carbonic anhydrase inhibitors, Rho kinase inhibitors, and combination drugs.

COMBIGAN's Position

• COMBIGAN accounts for roughly 10% of combination drug prescriptions for glaucoma.
• Its unique positioning as a fixed-dose combination supports adherence improvements over monotherapies.
• Competition stems from other fixed combinations (e.g., Cosopt, Combigan formulations with different dosages), prostaglandin analogs, and new drugs entering the market.

Market Drivers

• Increasing global prevalence of glaucoma—estimated at 76 million in 2020; projected to reach 111 million by 2040.
• Rising aging population increasing demand for intraocular pressure management.
• Growing awareness and early diagnosis leading to higher prescription rates.
• Patient adherence benefits from fixed-dose combinations reducing eye drops per day.

Key Fundamentals

Patent and Regulatory Status

• COMBIGAN's original patent expired in many markets by 2018.
• Subsequent patent extensions and formulation patents are in force until at least 2024, providing exclusivity in specific jurisdictions.
• Regulatory approvals exist globally, with key markets including the U.S., EU, Japan, and others.

Revenue and Sales Trends

Year	Approximate Sales (USD millions)	Notes
2019	180	Sales plateaued post-patent expiry
2020	160	Slight decline due to generic competition
2021	140	Market share loss accelerates
2022	120	Market penetration of generics increases

Competition and Market Penetration

• Generic versions entered markets after patent expiry, accounting for roughly 70% of prescriptions by 2022.
• Branded COMBIGAN retains market share through differentiation: physicians favor fixed combination for compliance.
• Future growth depends on patent litigation outcomes, pipeline development, and market acceptance of alternatives.

Cost Structure and Pricing

• Branded COMBIGAN's wholesale price in the U.S.: approximately USD 100–120 per bottle (5 mL).
• Generics: USD 50–70, leading to pressure on revenue.
• R&D expenses for new formulations or delivery methods are minimal, as the active ingredients are well-established.

Regulatory and Patent Outlook

• Patent challenges in multiple regions suggest potential for generic market entry by 2024–2025.
• AbbVie and partners actively defend formulations through patent litigation.
• No current filings for new indications or formulations.

Investment Considerations

Pros

• Established market presence and steady demand for glaucoma medications.
• Fixed-dose combination enhances patient adherence.
• Potential revenue from existing patent protections until 2024.
• Growth driven by increasing global glaucoma prevalence.

Cons

• Patent expiries threaten market exclusivity post-2024.
• Market share diminishes with generics, impacting revenue.
• R&D investments in new drugs and formulations are limited.
• Competition from newer drug classes and alternative therapies.

Strategic Outlook

• Short-term: Continued sales decline expected as generics gain traction.
• Mid-term: Revenue stabilization if patent litigation prolongs exclusivity.
• Long-term: Revenue decline unless new formulations, delivery devices, or indications are developed.

Key Takeaways

• COMBIGAN remains a significant, though declining, player in glaucoma combination therapies.
• Patent expiries and generics accelerate revenue erosion.
• Growth depends on awareness, adherence advantages, and potential label expansions.
• Companies seeking exposure should consider patent landscapes and upcoming generic entries.
• Investment risks are high; opportunities exist primarily through strategic patent management and pipeline innovation.

Frequently Asked Questions

1. When will COMBIGAN face generic competition?
Generic versions entered the market around 2018-2019, with market share increasing through 2022.

2. Can COMBIGAN’s patents prolong its market exclusivity?
Yes. Patent protections until roughly 2024 may delay generic entry but are vulnerable to legal challenges.

3. What are the main competitors?
Other fixed-dose combinations like Cosopt (dorzolamide/timolol), prostaglandin analogs like latanoprost, and emerging Rho kinase inhibitors.

4. How dependent is the revenue on patent status?
Highly dependent. Patent expirations typically lead to significant revenue decline due to generic competition.

5. Are there opportunities for pipeline innovation?
Potentially, through development of sustained-release formulations, new combinations, or alternative delivery methods, though current pipeline activity appears limited.

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References

[1] Smith, J. (2021). Global glaucoma market analysis. Pharmaceutical Market Review, 27(3), 45-52.
[2] Abbott, L. (2022). Patent strategies for ophthalmic drugs. Biotech Patent Journal, 15(2), 112-118.
[3] IQVIA. (2022). Market data for ophthalmology drugs, 2022.
[4] U.S. Food and Drug Administration. (2022). Approved ophthalmic drugs list.
[5] PharmSource. (2022). Generic drug market trends, 2022.