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Last Updated: October 4, 2024

BREXPIPRAZOLE Drug Patent Profile


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Which patents cover Brexpiprazole, and when can generic versions of Brexpiprazole launch?

Brexpiprazole is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Optimus, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms. and is included in ten NDAs.

The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Brexpiprazole

A generic version of BREXPIPRAZOLE was approved as brexpiprazole by OPTIMUS on October 25th, 2023.

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Drug patent expirations by year 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
Unity Health TorontoPhase 4

See all BREXPIPRAZOLE clinical trials

Pharmacology for BREXPIPRAZOLE
Anatomical Therapeutic Chemical (ATC) Classes 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
Optimus BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213758-005 Oct 25, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213512-002 Mar 17, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa Inc BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213692-001 Aug 11, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213660-006 Jan 10, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213570-003 Sep 26, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa Inc BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213692-002 Aug 11, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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