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Brexpiprazole - Generic Drug Details
What are the generic drug sources for brexpiprazole and what is the scope of patent protection?
Brexpiprazole
is the generic ingredient in one branded drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brexpiprazole has fifty-nine patent family members in thirty-three countries.
There are eight drug master file entries for brexpiprazole. One supplier is listed for this compound.
Summary for brexpiprazole
| International Patents: | 59 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 59 |
| Patent Applications: | 93 |
| 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 |
|---|---|
| University of Colorado, Denver | Phase 2 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
| Otsuka Beijing Research Institute | Phase 1 |
Recent Litigation for brexpiprazole
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. v. Ajanta Pharma Ltd. | 2019-10-11 |
Pharmacology for brexpiprazole
| Drug Class | Atypical Antipsychotic |
Synonyms for brexpiprazole
| 2(1H)-Quinolinone, 7-(4-(4-benzo(b)thien-4-yl-1-piperazinyl)butoxy)- |
| 2J3YBM1K8C |
| 7-(4-(4-(1-Benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1H)-one |
| 7-(4-(4-(Benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1H)-one |
| 7-[4-(4-benzo[b]thien-4-yl-1-piperazinyl)butoxy]- 2(1H)-Quinolinone |
| 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one |
| 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one |
| 7-[4-(4-Benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]-1H-quinolin-2-one |
| 7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1H-quinolin-2-one |
| 913611-97-9 |
| AC-30404 |
| AK171366 |
| AKOS025291100 |
| AX8306230 |
| BC600277 |
| BCP10218 |
| BCP24077 |
| Brexpiprazole (JAN/USAN/INN) |
| Brexpiprazole [USAN:INN] |
| Brexpiprazole; OPC-34712 |
| Brexpiprazole.2H2O |
| Brexpiprazole(OPC34712) |
| CHEBI:134716 |
| CHEMBL2105760 |
| CS-2108 |
| D10309 |
| DB09128 |
| DTXSID40238527 |
| EX-A2639 |
| FT-0712292 |
| GTPL7672 |
| HY-15780 |
| KS-0000063N |
| MolPort-039-063-477 |
| MolPort-046-033-502 |
| NCGC00378574-02 |
| OPC 34712 |
| OPC-34712 |
| OPC34712 |
| Rexulti |
| Rexulti (TN) |
| Rxulti |
| s4639 |
| SB16735 |
| SCHEMBL1037592 |
| SCHEMBL14772509 |
| UNII-2J3YBM1K8C |
| ZINC84758479 |
| ZKIAIYBUSXZPLP-UHFFFAOYSA-N |
Paragraph IV (Patent) Challenges for BREXPIPRAZOLE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| REXULTI | TABLET;ORAL | brexpiprazole | 205422 | 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 Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-002 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-006 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-002 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for brexpiprazole
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 103889425 | Start Trial |
| Denmark | 1869025 | Start Trial |
| China | 107397730 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brexpiprazole
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1869025 | 303 50013-2018 | Slovakia | Start Trial | PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730 |
| 1869025 | PA2018509,C1869025 | Lithuania | Start Trial | PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
| 1869025 | PA2018509 | Lithuania | Start Trial | PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; 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 verifification 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.
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