PERSERIS KIT Drug Patent Profile
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Which patents cover Perseris Kit, and what generic alternatives are available?
Perseris Kit is a drug marketed by Indivior and is included in one NDA. There are ten 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. Forty-one suppliers are listed for this compound. Additional details are available on the risperidone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Perseris Kit
A generic version of PERSERIS KIT was approved as risperidone by RISING on October 8th, 2008.
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Questions you can ask:
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Summary for PERSERIS KIT
| International Patents: | 38 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 143 |
| Clinical Trials: | 1 |
| 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 |
US Patents and Regulatory Information for PERSERIS KIT
PERSERIS KIT is protected by ten US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indivior | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Indivior | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-002 | Jul 27, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Indivior | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | DISCN | 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 |
Expired US Patents for PERSERIS KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Indivior | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-001 | Jul 27, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Indivior | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-002 | Jul 27, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for PERSERIS KIT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Laboratorios Farmacéuticos Rovi, S.A. | Okedi | risperidone | EMEA/H/C/005406Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. | Authorised | no | no | no | 2022-02-14 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PERSERIS KIT
See the table below for patents covering PERSERIS KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2008262545 | Sustained delivery formulations of risperidone compounds | ⤷ Start Trial |
| Brazil | PI0811319 | COMPOSIÇÃO FLUIDA, MÉTODO DE FORMAÇÃO DE UMA COMPOSIÇÃO FLUIDA, IMPLANTE BIODEGRÁDAVEL FORMADO IN SITU, MÉTODO DE FORMAÇÃO DE UM IMPLANTE BIODEGRADÁVEL IN SITU, KIT, IMPLANTE E MÉTODO DE TRATAENTO | ⤷ Start Trial |
| Canada | 2687979 | FORMULATIONS D'ADMINISTRATION PROLONGEE DE COMPOSES DE RISPERIDONE (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >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 |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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