By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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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
Summary for REXULTI
| International Patents: | 70 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 9 |
| Patent Applications: | 307 |
| Drug Prices: | Drug price information for REXULTI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REXULTI |
| What excipients (inactive ingredients) are in REXULTI? | REXULTI excipients list |
| DailyMed Link: | REXULTI at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Phase 2/Phase 3 |
| Queen's University | Phase 3 |
| Baycrest | Phase 3 |
Pharmacology for REXULTI
| Drug Class | Atypical Antipsychotic |
ATC Classes 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 |
International Patents for REXULTI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0609785 | Get Started Free |
| World Intellectual Property Organization (WIPO) | 2013054872 | Get Started Free |
| Hungary | E047493 | Get Started Free |
| Japan | 2017088610 | Get Started Free |
| Argentina | 053577 | Get Started Free |
| >Country | >Patent Number | >Estimated 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 |
