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ALPHAGAN P Drug Profile

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Which patents cover Alphagan P, and what substitute generic drugs are available?

Alphagan P is a drug marketed by Allergan and is included in two NDAs. 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. Twelve 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
Clinical Trials: see list8
Drug Prices:see details
DailyMed Link:ALPHAGAN P at DailyMed

Pharmacology for Tradename: ALPHAGAN P

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYesYes6,562,873*PED► SubscribeY► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYesYes6,627,210*PED► SubscribeY► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYesYes6,673,337*PED► SubscribeY► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYesYes6,641,834*PED► SubscribeY► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYesYes6,627,210*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: ALPHAGAN P

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► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 20055,424,078*PED► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20015,736,165*PED► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,465,464*PED► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,248,741*PED► Subscribe
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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 Korea100757656► Subscribe
Canada2578784► Subscribe
Australia2005280259► Subscribe
South Africa200207413► Subscribe
Argentina033539► 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: ALPHAGAN P

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
C0056France► SubscribePRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 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
14/041Ireland► SubscribePRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
0683Netherlands► 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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