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-four patent family members in thirty-seven countries.

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

Summary for BREXPIPRAZOLE

International Patents:	74
US Patents:	6
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	73
Patent Applications:	641
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREXPIPRAZOLE
What excipients (inactive ingredients) are in BREXPIPRAZOLE?	BREXPIPRAZOLE excipients list
DailyMed Link:	BREXPIPRAZOLE at DailyMed

Recent Clinical Trials for BREXPIPRAZOLE

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

Sponsor	Phase
H. Lundbeck A/S	Phase 4
Iqvia Pty Ltd	Phase 1
Unity Health Toronto	Phase 4

See all BREXPIPRAZOLE clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	1MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	0.5MG	TABLET;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

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for BREXPIPRAZOLE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718-003	Feb 3, 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
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-002	Jul 10, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Aurobindo Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213659-006	Nov 2, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-006	Jul 10, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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

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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

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Country	Patent Number	Title	Estimated Expiration
Argentina	053577	PIPERAZIN-BENZOTIOFENOS SUSTITUIDOS PARA EL TRATAMIENTO DE DESORDENES MENTALES	⤷ Sign Up
Japan	4315393		⤷ Sign Up
India	2055DEN2014		⤷ Sign Up
Slovenia	2767285		⤷ Sign Up
Luxembourg	C00086		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BREXPIPRAZOLE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	PA2018509	Lithuania	⤷ Sign Up	PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	122018000088	Germany	⤷ Sign Up	PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	303 50013-2018	Slovakia	⤷ Sign Up	PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	C01869025/01	Switzerland	⤷ Sign Up	PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018
1869025	32/2018	Austria	⤷ Sign Up	PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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