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Last Updated: November 27, 2022

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 two branded drugs marketed by Sandoz Inc, Teva Pharms Usa Inc, and Otsuka, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexpiprazole has seventy-two patent family members in thirty-seven countries.

There are eight drug master file entries for brexpiprazole. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for brexpiprazole
Recent Clinical Trials for brexpiprazole

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

SponsorPhase
H. Lundbeck A/SPhase 4
Iqvia Pty LtdPhase 1
Queen's UniversityPhase 4

See all brexpiprazole clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing4MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing3MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing2MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brexpiprazole
Paragraph IV (Patent) Challenges for BREXPIPRAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
REXULTI Tablets brexpiprazole 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg 205422 18 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 205422-005 Jul 10, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-006 Jul 10, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa Inc BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213692-001 Aug 11, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for brexpiprazole

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V. Rxulti brexpiprazole EMEA/H/C/003841
Treatment of schizophrenia.
Authorised no no no 2018-07-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for brexpiprazole

Country Patent Number Title Estimated Expiration
Japan 6084161 See Plans and Pricing
Luxembourg C00086 See Plans and Pricing
Poland 2767285 See Plans and Pricing
South Africa 201402333 TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN -1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF See Plans and Pricing
China 103889425 TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for brexpiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 2018C/037 Belgium See Plans and Pricing PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 303 50013-2018 Slovakia See Plans and Pricing PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 18C0004 France See Plans and Pricing PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 SPC/GB18/038 United Kingdom See Plans and Pricing PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/18/1294/001(NI) 20180730; UK PLGB 506970019 20180730; UK PLGB 506970020 20180730; UK PLGB 506970021 20180730; UK PLGB 506970022 20180730; UK PLGB 506970023 20180730; UK EU/1/18/1294/007(NI) 20180730; UK EU/1/18/1294/008(NI) 20180730; UK EU/1/18/1294/009(NI) 20180730; UK EU/1/18/1294/010(NI) 20180730; UK EU/1/18/1294/011(NI) 20180730; UK PLGB 506970024 20180730; UK EU/1/18/1294/002(NI) 20180730; UK EU/1/18/1294/003(NI) 20180730; UK EU/1/18/1294/004(NI) 20180730; UK EU/1/18/1294/005(NI) 20180730; UK EU/1/18/1294/006(NI) 20180730
1869025 LUC00086 Luxembourg See Plans and Pricing 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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