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Last Updated: February 27, 2021

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Brexpiprazole - Generic Drug Details

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What are the generic sources for brexpiprazole and what is the scope of freedom to operate?

Brexpiprazole is the generic ingredient in one branded drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexpiprazole has seventy patent family members in thirty-six countries.

There are eight drug master file entries for brexpiprazole. One supplier is listed for this compound.

Recent Clinical Trials for brexpiprazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Douglas Mental Health University InstitutePhase 3
Jewish General HospitalPhase 3
University of Colorado, DenverPhase 2

See all brexpiprazole clinical trials

Pharmacology for brexpiprazole
Paragraph IV (Patent) Challenges for BREXPIPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
REXULTI TABLET;ORAL brexpiprazole 205422 2019-07-10

US Patents and Regulatory Information for brexpiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-006 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-002 Jul 10, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-002 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for brexpiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 18C0004 France   Start Trial PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 1890028-2 Sweden   Start Trial PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025 PA2018509,C1869025 Lithuania   Start Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 2018C/037 Belgium   Start Trial PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 C01869025/01 Switzerland   Start Trial PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018
1869025 LUC00086 Luxembourg   Start Trial PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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