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Last Updated: June 24, 2021

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ALPHAGAN P Drug Profile


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Which patents cover Alphagan P, and when can generic versions of Alphagan P launch?

Alphagan P is a drug marketed by Allergan and is included in two NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-five patent family members in twenty-three countries.

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

Paragraph IV (Patent) Challenges for ALPHAGAN P
Tradename Dosage Ingredient NDA Submissiondate
ALPHAGAN P SOLUTION/DROPS;OPHTHALMIC brimonidine tartrate 021770 2006-12-20
ALPHAGAN P SOLUTION/DROPS;OPHTHALMIC brimonidine tartrate 021262 2006-11-03

US Patents and Regulatory Information for ALPHAGAN P

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 AT RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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 ALPHAGAN P

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005   Try Before You Buy   Try Before You Buy
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001   Try Before You Buy   Try Before You Buy
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001   Try Before You Buy   Try Before You Buy
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ALPHAGAN P

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 300683 Netherlands   Try Before You Buy 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 2014/041 Ireland   Try Before You Buy PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 14C0056 France   Try Before You Buy PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 92462 Luxembourg   Try Before You Buy PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Medtronic
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Harvard Business School

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