COMBIGAN Drug Patent Profile
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Which patents cover Combigan, and when can generic versions of Combigan launch?
Combigan is a drug marketed by Abbvie and is included in one NDA.
The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Combigan
A generic version of COMBIGAN was approved as brimonidine tartrate; timolol maleate by SANDOZ on April 4th, 2022.
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Questions you can ask:
- What is the 5 year forecast for COMBIGAN?
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Summary for COMBIGAN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 22 |
| Patent Applications: | 42 |
| 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 |
Recent Clinical Trials for COMBIGAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hanlim Pharm. Co., Ltd. | Phase 4 |
| CHA University | Phase 4 |
| Salus University | Phase 4 |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COMBIGAN | Ophthalmic Solution | brimonidine tartrate; timolol maleate | 0.2%/0.5% | 021398 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for COMBIGAN
International Patents for COMBIGAN
See the table below for patents covering COMBIGAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | PA03008401 | COMBINACION DE BRIMONIDINA Y TIMOLOL PARA USO OFTALMICO, TOPICO. (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE.) | ⤷ Sign Up |
| Canada | 2440764 | COMBINAISON DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION TOPIQUE OPHTALMIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE) | ⤷ Sign Up |
| Denmark | 1496912 | ⤷ Sign Up | |
| China | 100558364 | ⤷ Sign Up | |
| Japan | 2005523316 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 03088973 | ⤷ Sign Up | |
| Mexico | 368377 | COMBINACION DE BRIMONIDINA Y TIMOLOL PARA USO OFTALMICO, TOPICO. (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMBIGAN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 300683 | 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 |
| 1631293 | 2014C/042 | Belgium | ⤷ Sign Up | 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 | C300683 | 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 |
| 1631293 | 2014/041 | Ireland | ⤷ Sign Up | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1631293 | 14C0056 | France | ⤷ Sign Up | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| 1631293 | 92462 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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