BRIMONIDINE TARTRATE; CARBACHOL - Generic Drug Details

What are the generic drug sources for brimonidine tartrate; carbachol and what is the scope of patent protection?

Brimonidine tartrate; carbachol is the generic ingredient in one branded drug marketed by Visus and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; carbachol has five patent family members in four countries.

One supplier is listed for this compound.

Summary for BRIMONIDINE TARTRATE; CARBACHOL

International Patents:	5
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	BRIMONIDINE TARTRATE; CARBACHOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BRIMONIDINE TARTRATE; CARBACHOL

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for BRIMONIDINE TARTRATE; CARBACHOL

Drug Class	Cholinergic Receptor Agonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cholinergic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE; CARBACHOL

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N07AB	Choline esters
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01EB	Parasympathomimetics
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BRIMONIDINE TARTRATE; CARBACHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes			Y

International Patents for BRIMONIDINE TARTRATE; CARBACHOL

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4429652
World Intellectual Property Organization (WIPO)	2023086878
Taiwan	202333662
China	118541148

Supplementary Protection Certificates for BRIMONIDINE TARTRATE; CARBACHOL

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	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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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

Market Dynamics and Financial Trajectory for Brimonidine Tartrate and Carbachol

Last updated: March 8, 2026

This report compares the market environment and financial outlooks for two ophthalmic drugs: brimonidine tartrate and carbachol.

What Are the Market Sizes and Growth Drivers?

Brimonidine Tartrate

• Market Size (2022): Estimated global revenue of $300 million (IQVIA, 2022).
• Growth Rate: Compound annual growth rate (CAGR) projected at 4.5% during 2023-2028.
• Key Indications: Primary open-angle glaucoma; ocular hypertension.
• Drivers: Increasing glaucoma prevalence; rising awareness of eye health; preference for topical formulations over surgical options.

Carbachol

• Market Size (2022): Approximately $50 million globally (MarketWatch, 2022).
• Growth Rate: CAGR estimated at 2.8% over the same period.
• Key Indications: Glaucoma, intraocular lens surgery; miosis induction.
• Drivers: Persistence of traditional treatments; usage in surgical procedures.

How Do Regulatory and Patent Environments Affect These Drugs?

Brimonidine Tartrate

• Patent Status: Patent expiration occurred in several markets by 2020.
• Regulatory Pathways: Approved by FDA (2000), EMA (1999); new formulations and combination therapies continue to seek approvals.
• Pipeline: Trials for sustained-release systems and fixed-dose combinations.

Carbachol

• Patent Status: No active patents; off-patent for decades.
• Regulatory Pathways: Approved by FDA (1950s), EMA (1960s); limited new formulations under development.
• Pipeline Activity: Minimal, mainly generic manufacturing.

Financial Trends Based on Market Penetration and Competition

Brimonidine Tartrate

• Market Penetration: Undergoes competition from prostaglandin analogs (e.g., latanoprost).
• Pricing: Average retail price in the U.S. around $50 per bottle; generics reduced prices by 20-30%.
• Revenue Trends: Slight decline observed post-2020, attributed to increased generic availability and competition.

Carbachol

• Market Penetration: Dominates in specific niches such as intraocular surgeries.
• Pricing: Approximately $10-$15 per vial.
• Revenue Trends: Stable, with minor fluctuations due to surgical demand cycles.

What Are the Key Market Risks and Opportunities?

Risks

• Brimonidine Tartrate: Patent expiry pressures, competition with newer therapies, regulatory hurdles for new formulations.
• Carbachol: Limited innovation; reliance on aging formulations; potential supply chain issues for generics.

Opportunities

• Brimonidine Tartrate: Development of sustained-release delivery; combination therapies aimed at improving patient compliance.
• Carbachol: Niche applications in surgical settings; potential for reformulation with improved safety profiles.

Financial Forecasts (2023-2028)

Drug	2023 Revenue (USD millions)	2028 Projected Revenue (USD millions)	CAGR (%)
Brimonidine Tartrate	290	370	4.5
Carbachol	52	58	2.8

Forecasts assume current trends persist, with competitive dynamics influencing future growth.

Key Takeaways

• Brimonidine tartrate presents a larger, faster-growing market with ongoing innovation efforts, especially in drug delivery systems. Patent cliffs and generic competition challenge revenue sustainably.
• Carbachol remains relevant in niche surgical applications, with limited growth prospects due to its age and lack of recent innovation.
• Both drugs’ revenues are sensitive to regulatory developments, patent statuses, and evolving treatment paradigms.

FAQs

1. What factors influence the growth of brimonidine tartrate in the market?
   Glaucoma prevalence growth, awareness initiatives, and new formulation developments drive expansion, but competition from newer agents limits potential.

2. Why is carbachol’s market size smaller than brimonidine tartrate’s?
   Its primary use in surgical settings and lack of recent innovation restrict broader adoption.

3. How do patent expirations impact revenue?
   Patent expirations enable generic entry, reducing prices and profit margins but can also stimulate market volume.

4. Are there emerging therapies that threaten these drugs?
   Yes, for brimonidine, prostaglandin analogs and combination therapies are leading competitors; for carbachol, its niche role faces competition from newer, more targeted agents.

5. What future trends could influence these market dynamics?
   Advances in sustained-release formulations, combination therapies, and personalized treatment strategies could alter growth trajectories.

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Sources

[1] IQVIA, 2022. Global ophthalmic market report. [2] MarketWatch, 2022. Ophthalmic drugs market analysis.