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Last Updated: May 25, 2022

COMBIGAN Drug Patent Profile


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

Combigan is a drug marketed by Allergan and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in nineteen countries.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

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

COMBIGAN is protected by eleven US patents.

Patents protecting COMBIGAN

Combination of brimonidine timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH ELEVATED INTRAOCULAR PRESSURE OR GLAUCOMA

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION, WITH COMPARABLE EFFICACY, AND A REDUCTION IN SPECIFIED ADVERSE EVENTS, COMPARED TO BRIMONIDINE 0.2% TID

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION, WITH A REDUCTION IN SPECIFIED ADVERSE EVENTS, COMPARED TO BRIMONIDINE 0.2% TID

Combination of brimonidine and timolol for topical ophthalmic use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION, WITH COMPARABLE EFFICACY TO BRIMONIDINE 0.2% TID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for COMBIGAN

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

International Patents for COMBIGAN

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

Country Patent Number Title Estimated Expiration
European Patent Office 1496912 ASSOCIATION DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION OPHTALMOLOGIQUE TOPIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE) See Plans and Pricing
Slovenia 1496912 See Plans and Pricing
Portugal 1496912 See Plans and Pricing
Brazil 0302584 Combinação de brimonidina e timolol para uso oftálmico tópico See Plans and Pricing
European Patent Office 2241319 Combinaison de brimonidine et timolol pour le traitement ophthalmique local (Combination of brimonidine and timolol for topical ophthalmic use) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMBIGAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 14C0056 France See Plans and Pricing PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014/041 Ireland See Plans and Pricing PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 C300683 Netherlands See Plans and Pricing 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 See Plans and Pricing 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 2014C/042 Belgium See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Dow
Mallinckrodt
Medtronic
McKinsey

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