Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: August 19, 2019

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Brimonidine tartrate; timolol maleate - Generic Drug Details

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What are the generic drug sources for brimonidine tartrate; timolol maleate and what is the scope of brimonidine tartrate; timolol maleate freedom to operate?

Brimonidine tartrate; timolol maleate is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; timolol maleate has twenty-five patent family members in nineteen countries.

There are eleven drug master file entries for brimonidine tartrate; timolol maleate. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for brimonidine tartrate; timolol maleate
Pharmacology for brimonidine tartrate; timolol maleate
Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Applicant Application No. Strength Dosage Form
  Try a Free Trial  Try a Free Trial0.2%; 0.5%SOLUTION; OPHTHALMIC
  Try a Free Trial  Try a Free Trial0.2%; 0.5%SOLUTION; OPHTHALMIC
  Try a Free Trial  Try a Free Trial0.2%; 0.5%SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for brimonidine tartrate; timolol maleate

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   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Try a Free Trial   Try a Free Trial   Try a Free Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for brimonidine tartrate; timolol maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 92462 Luxembourg   Try a Free 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 2014/041 Ireland   Try a Free Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 14C0056 France   Try a Free Trial PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014C/042 Belgium   Try a Free 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 C300683 Netherlands   Try a Free 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
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 verifification 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.