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:	75
Clinical Trials:	25
Patent Applications:	337
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	020490-001	Mar 13, 1997		DISCN	No	No
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
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
Australia	762641
Denmark	0835110
European Patent Office	1146877	(2-IMIDAZOLINE-2-YLAMINO) QUINOXALINES DESTINEES AU TRAITEMENT DE LESIONS NERVEUSES ((2-IMIDAZOLIN-2-YLAMINO) QUINOXALINES FOR THE TREATMENT OF NEURAL INJURY)
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.)
Portugal	835110
Spain	2333339

Supplementary Protection Certificates for ALPHAGAN

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	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	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	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 ALPHAGAN

Introduction to ALPHAGAN

ALPHAGAN, a brand of brimonidine tartrate ophthalmic solution, is a key player in the antiglaucoma drugs market. Developed by Allergan Inc., it is used to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.

Market Size and Growth of Antiglaucoma Drugs

The antiglaucoma drugs market, which includes ALPHAGAN, has been experiencing strong growth. In 2023, the market size was $15.07 billion and is expected to grow to $16.27 billion in 2024 at a compound annual growth rate (CAGR) of 7.9%. By 2028, the market is projected to reach $21.9 billion, driven by factors such as emerging markets, reimbursement policies, and disease awareness campaigns[1].

Product Innovations and Approvals

ALPHAGAN has undergone significant product innovations. For instance, the FDA approved a new formulation of brimonidine tartrate ophthalmic solution 0.1% (Alphagan P) in 2005. This new formulation improved bioavailability compared to the original Alphagan 0.2%, allowing for a reduced drug concentration without sacrificing efficacy[4].

Financial Performance of Allergan

Allergan, the parent company of ALPHAGAN, has shown robust financial performance in the past. In 2011, Allergan's glaucoma franchise, which includes ALPHAGAN, saw an 11% increase in sales to over $1 billion. This growth contributed to Allergan becoming the second-largest glaucoma company in the world[3].

Revenue Contributions

• Glaucoma Franchise: The glaucoma franchise, including ALPHAGAN, has been a significant contributor to Allergan's revenue. In 2011, this segment accounted for more than $1 billion in sales[3].
• Global Sales: Allergan's sales in emerging markets, where glaucoma treatments are increasingly in demand, grew by 25% in 2011, representing 17% of the company's total sales[3].

Market Segmentation and Trends

Segmentation by Product Type

The antiglaucoma drugs market is segmented by product type, with ALPHAGAN falling under the alpha agonist category. This category, along with others such as beta blockers, prostaglandin analogs, and combined medications, drives the market's growth[1].

Emerging Trends

• Technological Advancements: Innovations in drug formulations, such as the improved bioavailability of Alphagan P, are driving market growth.
• Telemedicine: The integration of telemedicine is expected to enhance patient access to glaucoma treatments, including ALPHAGAN.
• Sustainability: There is a growing focus on sustainability and eco-friendly packaging, which could influence future product development and market appeal[1].

Regional Market Performance

Asia-Pacific and Emerging Markets

The Asia-Pacific region has been a significant growth area for antiglaucoma drugs, including ALPHAGAN. Emerging markets in Asia, Latin America, and Eastern Europe have seen rapid growth, with Allergan's sales in these regions increasing by 25% in 2011[3].

North America and Europe

In North America and Europe, the market for antiglaucoma drugs is also robust. Allergan's strong presence in these regions, coupled with regulatory approvals and reimbursement policies, has contributed to the financial success of ALPHAGAN[1].

Impact of External Factors

COVID-19 and Economic Factors

The COVID-19 pandemic and economic factors such as inflation and the Ukraine-Russia war have had varying impacts on the market. However, the essential nature of glaucoma treatments has helped the market remain relatively resilient[1].

Competitive Landscape

ALPHAGAN operates in a competitive market with other major players offering various types of antiglaucoma drugs. Allergan's strong patent portfolio and continuous innovation have helped maintain its market position. For example, the company's licensing of a DARPin® protein targeting VEGF for retinal diseases further strengthens its pipeline[3].

Key Takeaways

• Market Growth: The antiglaucoma drugs market, including ALPHAGAN, is expected to grow significantly, driven by emerging markets and technological advancements.
• Product Innovations: Continuous innovation, such as the improved formulation of Alphagan P, enhances the product's efficacy and market appeal.
• Financial Performance: Allergan's glaucoma franchise, including ALPHAGAN, has contributed substantially to the company's revenue.
• Regional Growth: Emerging markets in Asia, Latin America, and Eastern Europe are key growth areas for ALPHAGAN.

FAQs

What is ALPHAGAN used for?

ALPHAGAN is used to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.

What is the new formulation of ALPHAGAN approved by the FDA?

The new formulation is brimonidine tartrate ophthalmic solution 0.1% (Alphagan P), which improves bioavailability and reduces drug concentration without sacrificing efficacy[4].

How has the COVID-19 pandemic affected the antiglaucoma drugs market?

The market has remained relatively resilient due to the essential nature of glaucoma treatments, despite some impacts from the pandemic and economic factors[1].

What are the key drivers of the antiglaucoma drugs market growth?

Key drivers include emerging markets, reimbursement policies, disease awareness campaigns, and technological advancements[1].

What is Allergan's strategy for maintaining market position in the glaucoma treatment market?

Allergan focuses on continuous innovation, strong patent portfolios, and strategic acquisitions to maintain its market position[3].