DrugPatentWatch Database Preview
COMBIGAN Drug Profile
When do Combigan patents expire, and when can generic versions of Combigan launch?
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-five 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.
Summary for COMBIGAN
| International Patents: | 25 |
| 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 |
| 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 |
Recent Litigation for COMBIGAN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALLERGAN SALES, LLC v. SANDOZ, INC. | 2017-10-30 |
| Allergan Sales, LLC v. Sandoz, Inc. | 2017-01-19 |
| Allergan, Inc. v. Sandoz, Inc. | 2012-04-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Ferrum Ferro Capital, LLC | 2015-03-09 |
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 |
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 | Y | 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 | 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 | |||
| >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 |
|---|---|---|
| Taiwan | I351959 | Start Trial |
| South Korea | 20040100844 | Start Trial |
| Canada | 2440764 | 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 | 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 |
| 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 | 14C0056 | France | Start Trial | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
