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ALPHAGAN P Drug Profile

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Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from two suppliers. There are six patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for Tradename: ALPHAGAN P

Patents:6
Applicants:1
NDAs:2
Suppliers / Packagers: see list2

Pharmacology for Tradename: ALPHAGAN P

Clinical Trials for: ALPHAGAN P

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes9,295,641*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYes8,858,961*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,627,210*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ALPHAGAN P

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20015,424,078*PED<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,248,741*PED<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,465,464*PED<disabled>
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Paragraph IV activity for: ALPHAGAN P

Drugname Dosage Strength RLD Submissiondate
brimonidine tartrateOphthalmic Solution0.10%Alphagan P12/20/2006
brimonidine tartrateOphthalmic Solution0.15%Alphagan P11/3/2006

International Patent Family for Tradename: ALPHAGAN P

Country Document Number Estimated Expiration
South Korea20030023700<disabled in preview>
Spain2392636<disabled in preview>
China1441679<disabled in preview>
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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: ALPHAGAN P

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