BRIMONIDINE TARTRATE; BRINZOLAMIDE - Generic Drug Details
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What are the generic sources for brimonidine tartrate; brinzolamide and what is the scope of patent protection?
Brimonidine tartrate; brinzolamide
is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brimonidine tartrate; brinzolamide has fifty-one patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for BRIMONIDINE TARTRATE; BRINZOLAMIDE
International Patents: | 51 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE; BRINZOLAMIDE |
DailyMed Link: | BRIMONIDINE TARTRATE; BRINZOLAMIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Generic Entry Date for BRIMONIDINE TARTRATE; BRINZOLAMIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/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 BRIMONIDINE TARTRATE; BRINZOLAMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Alcon Research | Phase 2 |
Hermann Eye Center | N/A |
Alcon Research | N/A |
Pharmacology for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Class | Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Carbonic Anhydrase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SIMBRINZA | Ophthalmic Suspension | brimonidine tartrate; brinzolamide | 1%/0.2% | 204251 | 1 | 2022-08-01 |
US Patents and Regulatory Information for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alcon Labs Inc | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Alcon Labs Inc | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | 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 |
Expired US Patents for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alcon Labs Inc | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Simbrinza | brinzolamide, brimonidine tartrate | EMEA/H/C/003698 Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. |
Authorised | no | no | no | 2014-07-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Chile | 2010000634 | Composicion oftalmica multidosis que comprende un primer poliol seleccionado de manitol y/o sorbitol, un segundo poliol seleccionado de propilenglicol y/o glicerina, borato en cantidad menor a 0,5% en p/v, cloruro de benzalconio en concentracion de 0.0007%-0,0035% p/v y agua y uso para el tratamiento de la presion intraocular elevada. | ⤷ Sign Up |
Poland | 3045164 | ⤷ Sign Up | |
Japan | 2016183198 | ボレート−ポリオール複合体を含む水性薬学的組成物 (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES) | ⤷ Sign Up |
Portugal | 2442790 | ⤷ Sign Up | |
Spain | 2803648 | ⤷ Sign Up | |
Spain | 2584858 | ⤷ Sign Up | |
Spain | 2461617 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRIMONIDINE TARTRATE; BRINZOLAMIDE
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 | 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 |
1631293 | 2014/041 | Ireland | ⤷ Sign Up | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/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 | 14C0056 | France | ⤷ Sign Up | 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 |
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