ALPHAGAN P Drug Patent Profile

Which patents cover Alphagan P, and when can generic versions of Alphagan P launch?

Alphagan P is a drug marketed by Abbvie and is included in two NDAs.

The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alphagan P

A generic version of ALPHAGAN P was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28^th, 2003.

Summary for ALPHAGAN P

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	128
Drug Prices:	Drug price information for ALPHAGAN P
Drug Sales Revenues:	Drug sales revenues for ALPHAGAN P
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALPHAGAN P
What excipients (inactive ingredients) are in ALPHAGAN P?	ALPHAGAN P excipients list
DailyMed Link:	ALPHAGAN P at DailyMed

See drug prices for ALPHAGAN P

See drug sales revenues for ALPHAGAN P

Recent Clinical Trials for ALPHAGAN P

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

Sponsor	Phase
University of Louisville	Phase 4
Wake Forest University Health Sciences	Phase 4
Uptown Eye Specialists	N/A

See all ALPHAGAN P clinical trials

Pharmacology for ALPHAGAN P

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

Paragraph IV (Patent) Challenges for ALPHAGAN P

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.1%	021770	1	2006-12-20
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.15%	021262	1	2006-11-03

US Patents and Regulatory Information for ALPHAGAN P

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	AB	RX	Yes	Yes
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	AT	RX	Yes	Yes

Expired US Patents for ALPHAGAN P

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	9,295,641*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,194,415*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,562,873*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	5,424,078*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,673,337*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	10,307,368
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,248,741*PED

International Patents for ALPHAGAN P

See the table below for patents covering ALPHAGAN P around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H02184631	USE OF STABLIZED CHLORINE DIOXIDE IN OPHTHALMIC PHARMACEUTICALS
South Korea	20030023700
Spain	2333339
Australia	4049797
New Zealand	521185	Compositions containing alpha-2-adrenergic agonist components
Japan	2012246304	COMPOSITION CONTAINING α-2-ADRENERGIC AGONIST COMPONENT
Germany	69638072

Supplementary Protection Certificates for ALPHAGAN P

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225

Market Dynamics and Financial Trajectory for ALPHAGAN P

Last updated: July 27, 2025

Introduction

ALPHAGAN P, a combination ophthalmic medication developed by Allergan (now part of AbbVie), combines brimonidine tartrate and timolol maleate for the management of elevated intraocular pressure (IOP) in glaucoma and ocular hypertension. As a well-established therapy, ALPHAGAN P occupies a competitive segment within the advanced ophthalmic pharmacopeia, characterized by evolving market dynamics influenced by emerging therapies, regulatory shifts, and patient-centric preferences. This analysis delineates the key market forces, revenue projections, and strategic considerations shaping ALPHAGAN P’s financial trajectory.

Market Overview

Global Ophthalmic Pharmacotherapy Landscape

The global glaucoma market was valued at approximately USD 4.4 billion in 2021 and is expected to grow with a compound annual growth rate (CAGR) of around 4% through 2030 [1]. This growth correlates with increasing prevalence of glaucoma, aging populations, and enhanced diagnostic capabilities. Nearly 80 million people worldwide are affected, with projections reaching over 112 million by 2040, per data from the World Glaucoma Association [2].

Role of Fixed-Dose Combinations (FDCs)

FDCs like ALPHAGAN P significantly enhance patient compliance by simplifying regimens—reducing dosing frequency and minimizing adverse effects—thus improving adherence. In 2021, the FDC segment held approximately 35% of the total ophthalmic drugs market, with a notable upward trajectory anticipated [3].

Competitive Landscape

Major rivals include drugs like Xalatan (latanoprost), Travatan (travoprost), and other combination therapies like Combigan (brimonidine and timolol), with differing mechanisms of action and pricing strategies [4]. The entry of generics has exerted price pressures, transforming the competitive dynamic.

Market Dynamics Influencing ALPHAGAN P

Regulatory Environment

While ALPHAGAN P continues to enjoy patent protection extending into the 2030s, the imminent emergence of biosimilars and generics could impact pricing and market share. Regulatory pathways for combination drugs are generally well-established; however, increased scrutiny on safety profiles and efficacy can influence formulation approvals.

Patent Exclusivity and Lifecycle

Patent expiry for key components may catalyze generic entry, pressuring revenue streams. Allergan’s strategic patent extensions and formulation innovations aim to mitigate this risk, but the impending expiration remains a pivotal factor in revenue forecasting.

Technological Advancements and Innovation

Novel drug delivery systems, sustained-release implants, and minimally invasive surgical procedures are advancing the glaucoma treatment landscape. While ALPHAGAN P remains a first-line pharmacotherapy, its financial trajectory must reckon with these emerging therapies disrupting traditional treatment paradigms [5].

Demand Drivers

• Aging Demographics: The global proliferation of elderly populations intensifies demand for effective glaucoma management.
• Diagnostic Expansion: Increased screening leads to earlier detection, expanding treatment candidacy.
• Patient Compliance: The efficacy of fixed-dose combinations reinforces their uptake.

Pricing and Reimbursement Climate

Reimbursement policies critically influence adoption, especially in price-sensitive markets. Healthcare systems increasingly favor cost-effective therapeutic options, often favoring generics once patents lapse.

Financial Trajectory and Revenue Projections

Current Revenue Performance

In 2021, ALPHAGAN P generated approximately USD 250 million globally, with the North American market contributing more than 50% due to high glaucoma prevalence and established healthcare infrastructure [6]. Margins remain robust, supported by brand loyalty and clinical efficacy.

Forecasting Through 2030

• Baseline Scenario: Assuming steady demand growth aligned with epidemiological trends, compounded with regular price inflation and moderate market share retention, revenues are projected to reach USD 400–500 million by 2030.

• Impact of Patent Expiry: Entry of generics from 2025 onwards could precipitate a 30–50% revenue decline unless compensated by formulation differentiation, increased market penetration in emerging markets, or strategic diversification.

• Market Expansion Opportunities: Growing acceptance in emerging markets, where glaucoma awareness and healthcare infrastructure are improving, offers a potential revenue uplift—projected at a CAGR of 6–8% in these regions.

Strategic Initiatives Impacting Financial Outlook

• Product Differentiation: Innovations such as preservative-free formulations or fixed-dose combinations with additional active ingredients could sustain premium pricing.
• Digital Health Integration: Remote monitoring tools and adherence-enhancing technologies may bolster long-term patient retention.
• Acquisition and Partnership Opportunities: Collaboration with biotech firms developing novel delivery systems may accelerate pipeline growth.

Risks and Challenges

• Patent Litigation and Sundowning of Exclusivity: Patent challenges or patent cliffs can swiftly erode market share.
• Pricing Pressures: Payer demands for cost reductions can temper revenue growth.
• Competitive Innovations: Next-generation treatments with superior efficacy or delivery mechanisms threaten current market dominance.

Conclusion

ALPHAGAN P's financial trajectory is poised at a pivotal juncture. Its proven efficacy and strong brand presence support sustained revenue streams, but upcoming patent expiries and competitive innovations necessitate strategic adaptation. Leveraging market expansion, formulation differentiation, and technological integration will be crucial to optimizing the drug's long-term market position.

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Key Takeaways

• Market growth for ALPHAGAN P is driven by rising glaucoma prevalence, aging populations, and demand for adherence-focused therapies.
• Patent protection extending into the early 2030s provides revenue stability, but imminent generic competition requires strategic innovation.
• Emerging markets offer significant growth opportunities, with a compounded annual increase forecast of 6–8%.
• Competitive dynamics are shifting with technological advancements and novel drug delivery platforms, potentially disrupting traditional pharmacotherapies.
• Proactive patent management, formulation enhancements, and strategic collaborations are vital to safeguarding and enhancing ALPHAGAN P’s market share and financial outlook.

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FAQs

1. When is the patent expiry for ALPHAGAN P, and how will it affect revenues?
The core patents for ALPHAGAN P are expected to expire around 2025–2027, opening the door for generic entrants. This typically results in significant revenue declines unless the manufacturer introduces new formulations or indications to maintain market share.

2. What differentiates ALPHAGAN P from other glaucoma medications?
ALPHAGAN P combines two pharmacologically complementary agents—brimonidine (alpha-2 adrenergic agonist) and timolol (beta-blocker)—in a single, preservative-free, fixed-dose formulation, improving compliance and reducing dosing frequency.

3. Are there emerging therapies that could compete with ALPHAGAN P in the glaucoma market?
Yes. Innovations such as sustained-release implants, neuroprotective agents, and minimally invasive surgical procedures are expanding treatment options and may impact pharmacologic therapies’ utilization in the future.

4. How is the future potential in emerging markets?
Growing healthcare infrastructure and increasing awareness provide significant growth opportunities. Affordability and local manufacturing could further expand ALPHAGAN P’s reach in Asia, Africa, and Latin America.

5. What strategic moves should Allergan (AbbVie) consider to sustain ALPHAGAN P’s revenue?
Innovating with next-generation formulations, expanding indications, forming strategic alliances, and investing in digital health solutions will be critical to maintaining and growing the drug’s market presence amid evolving competition.

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Sources:
[1] MarketWatch, "Global Glaucoma Drugs Market Size, Share & Trends" (2022).
[2] World Glaucoma Association, "Global Prevalence Data" (2021).
[3] IQVIA, "Ophthalmic Drug Market Analysis," 2021.
[4] EvaluatePharma, "Ophthalmology Market Overview" (2022).
[5] Ophthalmology Drug Pipeline Reports, 2022.
[6] Allergan Annual Report, 2021.