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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Summary for BREXPIPRAZOLE
US Patents: | 0 |
Applicants: | 10 |
NDAs: | 10 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 73 |
Patent Applications: | 319 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BREXPIPRAZOLE |
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 |
Pharmacology for BREXPIPRAZOLE
Drug Class | Atypical Antipsychotic |
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 |