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PERSERIS KIT Drug Profile
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Which patents cover Perseris Kit, and when can generic versions of Perseris Kit launch?
Perseris Kit is a drug marketed by Indivior Inc and is included in one NDA. There are seven patents protecting this drug.
This drug has thirty-eight patent family members in seventeen countries.
The generic ingredient in PERSERIS KIT is risperidone. There are thirty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
US ANDA Litigation and Generic Entry Outlook for Perseris Kit
A generic version of PERSERIS KIT was approved as risperidone by APOTEX INC on January 20th, 2020.
Summary for PERSERIS KIT
| International Patents: | 38 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PERSERIS KIT |
| DailyMed Link: | PERSERIS KIT at DailyMed |
Recent Clinical Trials for PERSERIS KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Indivior Inc. | Phase 4 |
Recent Litigation for PERSERIS KIT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| United States v. Indivior Inc. | 2019-04-09 |
| Orlando Gateway Partners, LLC | 2015-04-20 |
US Patents and Regulatory Information for PERSERIS KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indivior Inc | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Indivior Inc | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Indivior Inc | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Indivior Inc | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-002 | Jul 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Indivior Inc | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | 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 PERSERIS KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1940351 | Start Trial |
| European Patent Office | 2907524 | Start Trial |
| Austria | 551989 | Start Trial |
| New Zealand | 597621 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007041410 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PERSERIS KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0196132 | 94C0008 | Belgium | Start Trial | PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
