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COMBIGAN Drug Profile
» See Plans and Pricing
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
Summary for COMBIGAN
International Patents: | 26 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 1 |
Clinical Trials: | 19 |
Formulation / Manufacturing: | see details |
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 |



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
Sponsor | Phase |
---|---|
EMS | Phase 3 |
McMaster University | N/A |
Carmel Medical Center | Phase 2 |
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 | 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 |
International Patents for COMBIGAN
Country | Patent Number | Estimated Expiration |
---|---|---|
Mexico | 368377 | Start Trial |
South Korea | 20040100844 | Start Trial |
Hong Kong | 1067549 | Start Trial |
European Patent Office | 1496912 | Start Trial |
Brazil | 0302584 | Start Trial |
Norway | 326579 | Start Trial |
>Country | >Patent Number | >Estimated 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 |