DrugPatentWatch Database Preview
COMBIGAN Drug Profile
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.
Summary for COMBIGAN
| 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 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COMBIGAN |
| DailyMed Link: | COMBIGAN at DailyMed |
Generic Entry Opportunity Date for COMBIGAN
*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.
Pharmacology for COMBIGAN
| Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
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 |
Paragraph IV (Patent) Challenges for COMBIGAN
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Ophthalmic Solution | 0.2%/0.5% | ➤ Subscribe | ➤ Sign Up |
International Patents for COMBIGAN
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200402296 | ➤ Sign Up |
| Brazil | 0302584 | ➤ Sign Up |
| Spain | 2399045 | ➤ Sign Up |
| Japan | 2005523316 | ➤ Sign Up |
| Norway | 20044450 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 03088973 | ➤ Sign Up |
| Cyprus | 1114048 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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 |
