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COMBIGAN Drug Profile

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Combigan is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in eighteen countries.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for Tradename: COMBIGAN

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes7,030,149► subscribe ► subscribe
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes9,474,751► subscribeY ► subscribe
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes8,133,890► subscribe ► subscribe
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Paragraph IV activity for: COMBIGAN

Drugname Dosage Strength RLD Submissiondate
brimonidine tartrate and timolol maleateOphthalmic Solution0.2%/0.5%Combigan11/21/2008

International Patent Family for Tradename: COMBIGAN

Country Document Number Estimated Expiration
China1516588► subscribe
EcuadorSP034742► subscribe
Norway20044450► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: COMBIGAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
462Luxembourg► subscribePRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
00683Netherlands► subscribePRODUCT 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
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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.

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