ALPHAGAN Drug Patent Profile

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

Alphagan is a drug marketed by Allergan and Abbvie and is included in four NDAs.

The generic ingredient in ALPHAGAN 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

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

Summary for ALPHAGAN

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	170
Drug Prices:	Drug price information for ALPHAGAN
Drug Sales Revenues:	Drug sales revenues for ALPHAGAN
DailyMed Link:	ALPHAGAN at DailyMed

See drug prices for ALPHAGAN

Recent Clinical Trials for ALPHAGAN

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 clinical trials

US Patents and Regulatory Information for ALPHAGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996		DISCN	Yes	No
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	AT	RX	Yes	Yes
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020490-001	Mar 13, 1997		DISCN	No	No
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	AB	RX	Yes	Yes

Expired US Patents for ALPHAGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996

International Patents for ALPHAGAN

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

Country	Patent Number	Title	Estimated Expiration
China	1197391
Mexico	9710480	METODO DE USO DE (2-IMIDAZOLIN-2-ILAMINO) QUINOXALINAS PARA TRATAR LESIONES DEL NERVIO OPTICO. (METHOD OF USING (2-IMIDAZOLIN-2-YLAMINO) QUINOXALINES IN TREATING OCULAR NEURAL INJURY.)
Denmark	0835110
Hong Kong	1040938

Supplementary Protection Certificates for ALPHAGAN

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	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/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
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 ALPHAGAN

Last updated: July 31, 2025

---

Introduction

ALPHAGAN, a brand name for brimonidine tartrate ophthalmic solution, plays a crucial role in the management of glaucoma and ocular hypertension. As a selective alpha-2 adrenergic receptor agonist, ALPHAGAN offers a novel therapeutic pathway, contributing to a substantial segment within ophthalmic pharmaceuticals. This analysis examines the current and projected market dynamics, including competitive landscape, regulatory factors, innovation trends, and financial trajectories shaping ALPHAGAN's future.

---

Market Overview

Global Ophthalmic Drug Market Growth
The ophthalmic drug market is anticipated to expand at a compound annual growth rate (CAGR) of approximately 4-6% through 2030, driven by escalating prevalence of age-related eye conditions and technological advancements [1]. Glaucoma prevalence affects over 76 million globally, projected to reach 112 million by 2040 [2], underpinning sustained demand.

Position of ALPHAGAN
Within this landscape, ALPHAGAN holds significant market share, especially in regions like North America, Europe, and parts of Asia, where chronic disease management facilitates long-term medication adherence. Its unique mechanism—mediating intraocular pressure (IOP) reduction—complements other drug categories such as prostaglandin analogs and beta blockers.

---

Market Dynamics Influencing ALPHAGAN

1. Competitive Landscape and Market Penetration

ALPHAGAN faces stiff competition from dominant classes like prostaglandin analogs (e.g., Latanoprost, Travoprost) and fixed-dose combination therapies. However, its distinct mechanism offers certain advantages, such as fewer allergy-related side effects compared to alternatives like timolol. Patents on ALPHAGAN expired or are nearing expiry in key markets, opening opportunities for generic entry, which can pressure pricing and margins.

2. Patent Lifecycle and Generic Competition

Patent expirations, notably in major markets like the U.S. and Europe, are pivotal. The entry of generics typically causes price erosion, impacting revenue streams. For example, generic brimonidine products launched post-patent expiry led to a 40-60% price reduction in some regions [3].

3. Regulatory Environment and Approvals

Regulatory agencies, including the FDA and EMA, have endorsed ALPHAGAN's safety and efficacy profile, facilitating lifecycle management strategies such as formulation modifications. Nonetheless, evolving standards on ocular drug safety and bioequivalence tests influence product development and market access.

4. Innovation and Formulation Developments

The pipeline features sustained-release formulations and combination therapies integrating brimonidine to enhance adherence and efficacy. These innovations could mitigate generic competition and drive premium pricing, thus influencing ALPHAGAN’s financial trajectory.

5. Geographic Market Trends

Emerging markets like China and India are witnessing rising glaucoma prevalence, intensifying demand. Local regulators' approval processes, pricing policies, and healthcare infrastructure significantly shape ALPHAGAN’s market penetration potential.

---

Financial Trajectory Analysis

Revenue Trends and Projections

• Historical Performance: Historical revenues in mature markets have grown modestly (~2-3% CAGR) due to patent protection and brand loyalty. Post-patent expiry, revenues typically declined unless offset by new formulations or indications.
• Forecasting Future Revenue: Assuming successful launches of improved formulations and expansion into emerging markets, ALPHAGAN could sustain a CAGR of approximately 3-5% over the next five years, reaching an estimated valuation of $500 million to $700 million globally by 2028 (from current levels around $350 million [4]).

Profitability and Margin Outlook

Margins are expected to be pressured initially due to generic competition but could recover through premium formulations and geographic diversification. R&D investments aimed at innovative, sustained-release versions may weigh on near-term profitability but create long-term revenue streams.

Licensing and Partnership Opportunities

Pharmaceutical companies are increasingly adopting licensing agreements for combination therapies involving ALPHAGAN, envisioned to solidify its market position and expand financial gains.

Pricing Dynamics

Pricing strategies will adapt in different regions, balancing patent protection advantages against market access considerations. The shift towards value-based pricing models, considering efficacy and safety, is notable.

---

Strategic Implications and Future Outlook

Lifecycle Management Strategies
Pharma companies are investing in reformulations, new delivery mechanisms, or combination drugs to extend ALPHAGAN’s market viability and profitability.

Emergence of Biosimilars and Generics
The upcoming entry of biosimilars post-patent expiry could significantly compress profit margins. Strategic mitigation includes patent extensions and expanding indications.

Digital and Data-Driven Initiatives
Leveraging digital health tools to improve patient adherence and real-world outcome data can enhance market share and financial health.

---

Key Market Drivers

• Aging populations and increasing glaucoma prevalence
• Technological advances enabling better drug delivery
• Expansion into emerging markets
• Strategic lifecycle management initiatives
• Increasing acceptance of combination therapies

Risks and Challenges

• Patent expiration-induced revenue impact
• Entry of low-cost generics/biosimilars
• Regulatory hurdles for new formulations
• Competitive pressure from alternative drug classes
• Regional disparities in market access

---

Conclusion

ALPHAGAN's market viability hinges on strategic lifecycle management, innovation, and geographic expansion. While patent expiries pose immediate financial challenges, opportunities lie in developing advanced formulations, efficacy-driven combination therapies, and penetrating emerging markets. Financial projections suggest a cautious but optimistic growth trajectory, provided companies adapt proactively to market pressures.

---

Key Takeaways

• ALPHAGAN operates within a competitive ophthalmic landscape shaped by patent cycles, innovation, and regional variability.
• Patent expiries and generic entry exert downward pressure on revenues but can be offset through formulation innovations and geographic diversification.
• Emerging markets present significant growth opportunities, especially with expanding glaucoma prevalence.
• Strategic investments in sustained-release and combination therapies are critical for maintaining profitability.
• Regulatory and market access dynamics require continuous monitoring to optimize ALPHAGAN’s financial trajectory.

---

FAQs

1. How does patent expiry influence ALPHAGAN's market share?
Patent expiry typically leads to generic introductions, significantly reducing brand-name revenue and market share unless mitigated by newer formulations or exclusive licensing deals.

2. What innovations are likely to sustain ALPHAGAN’s market presence?
Formulation improvements such as sustained-release delivery systems, combination therapies, and improved bioavailability are key drivers for continued relevance.

3. Which regions offer the highest growth potential for ALPHAGAN?
Emerging markets like China, India, and Latin America are poised for the highest expansion due to rising glaucoma cases and increasing healthcare infrastructure.

4. How does competition from other drug classes impact ALPHAGAN?
Prostaglandin analogs and fixed-dose combinations often outperform ALPHAGAN in terms of efficacy and convenience, pushing the brand to innovate and differentiate.

5. What strategies can pharma companies adopt to enhance profitability post-patent expiry?
Developing new formulations, exploring sizeable combination therapies, expanding into new indications, and penetrating underserved markets are effective approaches.

---

References

1. MarketsandMarkets. "Ophthalmic Drugs Market by Application, Route of Administration, and Geography." 2022.
2. Tham YC, et al. "Global prevalence of glaucoma and projections of glaucoma burden through 2040." Ophthalmology. 2014.
3. IQVIA. "Market Analysis of Brimonidine Post-Patent Expiry." 2021.
4. Evaluate Pharma. "Ophthalmic Drug Market Data & Forecasts." 2022.