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Generated: October 15, 2018

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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 seven patents protecting this drug and two Paragraph IV challenges.

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.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 AT RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 AT RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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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 ➤ Sign Up ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Sign Up ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Sign Up ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Sign Up ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Sign Up ➤ Sign Up
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ALPHAGAN P
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Solution 0.10% ➤ Subscribe ➤ Sign Up
➤ Subscribe Ophthalmic Solution 0.15% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ALPHAGAN P

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/041 Ireland ➤ Sign Up PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
0683 Netherlands ➤ Sign Up 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
462 Luxembourg ➤ Sign Up PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
00683 Netherlands ➤ Sign Up 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
C0056 France ➤ Sign Up PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fuji
McKesson
Daiichi Sankyo
US Department of Justice
Citi
Cantor Fitzgerald
Johnson and Johnson
US Army

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