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Last Updated: March 3, 2021

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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.

This drug has twenty-six 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. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Combigan

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 19, 2022. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $308mm indicating the motivation for generic entry (peak sales were $398mm in 2016).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (brimonidine tartrate; timolol maleate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for COMBIGAN
Drug Prices for COMBIGAN

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Drug Sales Revenue Trends for COMBIGAN

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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.

Recent Clinical Trials for COMBIGAN

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

SponsorPhase
EMSPhase 3
McMaster UniversityN/A
Carmel Medical CenterPhase 2

See all COMBIGAN clinical trials

Paragraph IV (Patent) Challenges for COMBIGAN
Tradename Dosage Ingredient NDA Submissiondate
COMBIGAN SOLUTION/DROPS;OPHTHALMIC brimonidine tartrate; timolol maleate 021398 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
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for COMBIGAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 2014/041 Ireland   Start Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 C300683 Netherlands   Start Trial 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   Start Trial PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014C/042 Belgium   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
>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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