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Last Updated: March 28, 2024

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 two branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Optimus, Sandoz, Teva Pharms Usa Inc, Zydus Pharms, and Otsuka, and is included in eleven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eight drug master file entries for brexpiprazole. Five suppliers are listed for this compound. There are five 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
McMaster UniversityPhase 4

See all BREXPIPRAZOLE clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial4MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial3MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial2MGTABLET;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 205422-004 Jul 10, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hetero Labs Ltd V BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213669-006 Nov 20, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-002 Jul 10, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
South Korea 20140075754 TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF ⤷  Try a Trial
Japan 2017088610 7−[4−(4−ベンゾ[b]チオフェン−4−イル−ピペラジン−1−イル)ブトキシ]−1H−キノリン−2−オン又はその塩を含む錠剤 (TABLET CONTAINING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF) ⤷  Try a Trial
Mexico 2007012626 BENZOTIOFENOS SUSTITUIDOS CON PIPERAZINA PARA EL TRATAMIENTO DE TRASTORNOS MENTALES. (PIPERAZINE-SUBSTITUTED BENZOTHIOPHENES FOR TREATMENT OF MENTAL DISORDERS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BREXPIPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 32/2018 Austria ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
1869025 PA2018509 Lithuania ⤷  Try a Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 122018000088 Germany ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.