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Last Updated: June 16, 2021

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REXULTI Drug Profile


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When do Rexulti patents expire, and when can generic versions of Rexulti launch?

Rexulti is a drug marketed by Otsuka and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has seventy patent family members in thirty-six countries.

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

DrugPatentWatch® Generic Entry Outlook for Rexulti

Rexulti was eligible for patent challenges on July 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2032. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for REXULTI
Drug Prices for REXULTI

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for REXULTI
Generic Entry Date for REXULTI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for REXULTI

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

SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 2/Phase 3
Queen's UniversityPhase 3
BaycrestPhase 3

See all REXULTI clinical trials

Pharmacology for REXULTI
Paragraph IV (Patent) Challenges for REXULTI
Tradename Dosage Ingredient NDA Submissiondate
REXULTI TABLET;ORAL brexpiprazole 205422 2019-07-10

US Patents and Regulatory Information for REXULTI

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 205422-006 Jul 10, 2015 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-004 Jul 10, 2015 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-001 Jul 10, 2015 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for REXULTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 CA 2018 00028 Denmark   Get Started Free PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025 CR 2018 00028 Denmark   Get Started Free PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025 PA2018509 Lithuania   Get Started Free PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 2018/034 Ireland   Get Started Free PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1294 20180726; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2402)
1869025 122018000088 Germany   Get Started Free 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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