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REXULTI Drug Profile
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» See Plans and PricingWhen do Rexulti patents expire, and when can generic versions of Rexulti launch?
Rexulti is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are five patents protecting this drug.
This drug has sixty-nine 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.
US ANDA Litigation and 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 has been one patent litigation case 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: | 69 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 9 |
| Patent Applications: | 66 |
| Drug Prices: | Drug price information for REXULTI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REXULTI |
| DailyMed Link: | REXULTI at DailyMed |
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 |
| McMaster University | Phase 3 |
| University Health Network, Toronto | Phase 3 |
Pharmacology for REXULTI
| Drug Class | Atypical Antipsychotic |
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 Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-006 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-004 | Jul 10, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | 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 REXULTI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2012321723 | Start Trial |
| Slovenia | 2767285 | Start Trial |
| Taiwan | 201318651 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for REXULTI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1869025 | 122018000088 | Germany | Start Trial | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
| 1869025 | LUC00086 | Luxembourg | Start Trial | PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730 |
| 1869025 | C01869025/01 | Switzerland | Start Trial | PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
