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Last Updated: June 25, 2022

Brimonidine tartrate; timolol maleate - Generic Drug Details


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What are the generic drug sources for brimonidine tartrate; timolol maleate and what is the scope of patent protection?

Brimonidine tartrate; timolol maleate is the generic ingredient in two branded drugs marketed by Apotex Inc, Sandoz Inc, and Allergan, and is included in three NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; timolol maleate has twenty-nine patent family members in nineteen countries.

Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for brimonidine tartrate; timolol maleate
Recent Clinical Trials for brimonidine tartrate; timolol maleate

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

SponsorPhase
AllerganPhase 3
Allergan
AllerganPhase 4

See all brimonidine tartrate; timolol maleate clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.2%; 0.5%SOLUTION; OPHTHALMIC
See Plans and PricingSee Plans and Pricing0.2%; 0.5%SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brimonidine tartrate; timolol maleate
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
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 brimonidine tartrate; timolol maleate

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 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 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
Sandoz Inc BRIMONIDINE TARTRATE AND TIMOLOL MALEATE brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091087-001 Apr 4, 2022 AB RX No No 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 brimonidine tartrate; timolol maleate

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 brimonidine tartrate; timolol maleate

Country Patent Number Title Estimated Expiration
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
Spain 2399045 See Plans and Pricing
Mexico 368377 COMBINACION DE BRIMONIDINA Y TIMOLOL PARA USO OFTALMICO, TOPICO. (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE.) See Plans and Pricing
Norway 326579 See Plans and Pricing
Denmark 1496912 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for brimonidine tartrate; timolol maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 92462 Luxembourg See Plans and Pricing 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 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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Johnson and Johnson
Medtronic
Colorcon
McKinsey

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