COMBIGAN Drug Patent Profile

Which patents cover Combigan, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	22
Patent Applications:	42
Drug Prices:	Drug price information for COMBIGAN
Drug Sales Revenues:	Drug sales revenues for COMBIGAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIGAN
What excipients (inactive ingredients) are in COMBIGAN?	COMBIGAN excipients list
DailyMed Link:	COMBIGAN at DailyMed

See drug prices for COMBIGAN

See drug sales revenues for COMBIGAN

Recent Clinical Trials for COMBIGAN

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

Sponsor	Phase
CHA University	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 4
Salus University	Phase 4

See all COMBIGAN clinical trials

Pharmacology for COMBIGAN

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Antagonists

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

Expired US Patents for COMBIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007

International Patents for COMBIGAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2440764	COMBINAISON DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION TOPIQUE OPHTALMIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE)
South Korea	100723189
European Patent Office	1496912	ASSOCIATION DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION OPHTALMOLOGIQUE TOPIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE)
Norway	326579
Spain	2399045
Taiwan	I351959

Supplementary Protection Certificates for COMBIGAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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

COMBIGAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMBIGAN

Introduction to COMBIGAN

COMBIGAN, a combination ophthalmic solution of brimonidine tartrate and timolol maleate, is a significant player in the antiglaucoma drugs market. Developed by Allergan (now part of AbbVie), this medication is designed to reduce intraocular pressure (IOP) in patients with glaucoma.

Market Position and Growth

Global Antiglaucoma Drugs Market

The antiglaucoma drugs market, within which COMBIGAN operates, has been experiencing robust growth. This market is projected to grow from $15.07 billion in 2023 to $16.27 billion in 2024, with a compound annual growth rate (CAGR) of 7.9%. By 2028, the market is expected to reach $21.9 billion, driven by factors such as an aging population, increasing healthcare expenditure, and regulatory approvals for new drugs[3].

Regional Dominance

North America, particularly the United States, dominates the ophthalmic drugs market, including the segment for antiglaucoma medications. This dominance is attributed to the rising prevalence of eye disorders like glaucoma, diabetic retinopathy, and cataracts, as well as a growing geriatric population. The presence of a large patient population and continuous product development activities by key market players further boost the demand for ophthalmic drugs in this region[1].

Product Specifics and Market Impact

Combination Therapy

COMBIGAN is a prime example of combination therapy in the treatment of glaucoma. It combines a beta-blocker (timolol) and an alpha agonist (brimonidine), offering patients the convenience of a single formulation that reduces the need for multiple individual drugs. This approach has been effective in lowering IOP and reducing long-term variability in IOP, which is crucial for slowing the progression of visual field loss in glaucoma patients[4].

Competitive Landscape

The market for antiglaucoma drugs is highly competitive, with several combination therapies available. Besides COMBIGAN, other notable combination drugs include Simbrinza (brinzolamide and brimonidine), Rockland (a rho kinase inhibitor and a prostaglandin analog), and Cosopt (beta-blockers and carbonic anhydrase inhibitors). These combination therapies have significantly improved treatment options for glaucoma patients, making the market more dynamic and competitive[3].

Financial Performance and Acquisitions

Historical Sales and Revenue

In the past, COMBIGAN has been a significant contributor to the revenue of its parent companies. For instance, in 2006, Allergan reported strong sales growth across its pharmaceutical businesses, including its eye care product line, which included COMBIGAN. The company's eye care pharmaceuticals product line saw a notable increase, with sales reaching $1,530.6 million, reflecting the strong market demand for such medications[2].

Acquisitions and Mergers

The ophthalmic drugs market has seen several strategic acquisitions and mergers that have impacted the financial trajectory of products like COMBIGAN. For example, in April 2022, Novartis' Sandoz expanded its eye drug offerings by acquiring Allergan's popular ocular hypertension medication. Similarly, Alcon's acquisition of Aerie Pharmaceuticals in August 2022 brought two commercialized glaucoma products and a pipeline of programs for other eye diseases under Alcon's portfolio, further indicating the active deal-making in this sector[1].

Regulatory and Safety Profile

Regulatory Approvals

COMBIGAN has received regulatory approvals in various regions, including outside the United States. It is approved in all member states of the European Union and other countries, contributing to its global market presence[5].

Safety and Efficacy

Clinical studies have shown that COMBIGAN is safe and well-tolerated, with an acceptable safety profile. The combination product has not shown any unique adverse reactions beyond those previously reported for its individual components. This safety profile has been a key factor in its market acceptance and continued use[4].

Future Outlook

Technological Advancements and Innovation

The future of COMBIGAN and similar antiglaucoma drugs is likely to be influenced by technological advancements, such as sustained-release formulations and biologics. Telemedicine and disease awareness campaigns are also expected to play a significant role in expanding the market. These trends suggest a continued growth trajectory for the antiglaucoma drugs market, including products like COMBIGAN[3].

Emerging Markets and Reimbursement Policies

Emerging markets and favorable reimbursement policies are expected to further drive the growth of the antiglaucoma drugs market. As healthcare systems in various countries improve and more people gain access to medical care, the demand for effective glaucoma treatments like COMBIGAN is likely to increase[3].

Key Takeaways

• Market Growth: The antiglaucoma drugs market, including COMBIGAN, is expected to grow significantly due to an aging population, increasing healthcare expenditure, and regulatory approvals.
• Combination Therapy: COMBIGAN's combination of brimonidine and timolol makes it an effective treatment option, reducing the need for multiple individual drugs.
• Competitive Landscape: The market is competitive with several combination therapies available, but COMBIGAN remains a significant player.
• Financial Performance: Historical sales data and recent acquisitions indicate a strong financial trajectory for COMBIGAN and similar products.
• Regulatory and Safety Profile: COMBIGAN has a favorable regulatory and safety profile, contributing to its market acceptance.
• Future Outlook: Technological advancements, emerging markets, and reimbursement policies are expected to drive continued growth.

FAQs

Q: What is COMBIGAN used for? A: COMBIGAN is used to reduce intraocular pressure (IOP) in patients with glaucoma.

Q: What are the active ingredients in COMBIGAN? A: COMBIGAN contains brimonidine tartrate and timolol maleate.

Q: How does COMBIGAN compare to other antiglaucoma drugs? A: COMBIGAN is a combination therapy that offers the convenience of a single formulation, reducing the need for multiple individual drugs. It is comparable to other combination therapies like Simbrinza and Cosopt.

Q: What is the expected market growth for antiglaucoma drugs? A: The antiglaucoma drugs market is expected to grow to $21.9 billion by 2028, with a CAGR of 7.7%.

Q: What factors drive the demand for COMBIGAN and similar drugs? A: Factors such as an aging population, increasing healthcare expenditure, regulatory approvals, and emerging markets drive the demand for COMBIGAN and similar antiglaucoma drugs.

Sources

1. The Global Ophthalmic Drugs Market to Surpass USD 47 Billion ... - PR Newswire
2. Reaching further. Living better. - Annual Reports
3. Antiglaucoma Drugs Global Market Report 2024 - Research and Markets
4. brimonidine tartrate / timolol ophthalmic solution - AbbVie
5. Unwavering Commitment - Annual Reports