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Last Updated: July 26, 2021

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Brexpiprazole - Generic Drug Details

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

Brexpiprazole is the generic ingredient in one branded drug marketed by Otsuka 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-one patent family members in thirty-seven countries.

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

Summary for brexpiprazole
Recent Clinical Trials for brexpiprazole

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

SponsorPhase
Otsuka Canada Pharmaceutical Inc.Phase 4
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 4
Lundbeck Canada Inc.Phase 4

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 REXULTI brexpiprazole TABLET;ORAL 205422-004 Jul 10, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-001 Jul 10, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever 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 2018C/037 Belgium ⤷  Free Forever Trial PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 LUC00086 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 122018000088 Germany ⤷  Free Forever Trial PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 PA2018509 Lithuania ⤷  Free Forever Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Colorcon
Baxter
AstraZeneca
Express Scripts

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