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Generated: October 15, 2018

DrugPatentWatch Database Preview

COMBIGAN Drug 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.

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

Drug patent expirations by year for COMBIGAN
Generic Entry Opportunity Date for COMBIGAN
Generic Entry Date for COMBIGAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for COMBIGAN
2-Propanol, 1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-, (2S)-, mixt. with 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine
952743-07-6
Brimonidine / timolol
Brimonidine mixture with timolol
Brimonidine tartrate / timolol maleate
Brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
Brimonidine tartrate and timolol maleate
Brimonidine Tartrate, Timolol Maleate Drug Combination
SCHEMBL5873369

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

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Paragraph IV (Patent) Challenges for COMBIGAN
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Solution 0.2%/0.5% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for COMBIGAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/041 Ireland ➤ Sign Up PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
0683 Netherlands ➤ Sign Up 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
462 Luxembourg ➤ Sign Up PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
00683 Netherlands ➤ Sign Up 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
C0056 France ➤ Sign Up PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Fish and Richardson
Healthtrust
Farmers Insurance
Queensland Health
Merck
Teva
Daiichi Sankyo

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