RISVAN Drug Patent Profile
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Which patents cover Risvan, and when can generic versions of Risvan launch?
Risvan is a drug marketed by Labs Farms Rovi Sa and is included in one NDA. There are fourteen patents protecting this drug.
This drug has one hundred and eighty-two patent family members in thirty-six countries.
The generic ingredient in RISVAN is risperidone. There are thirty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Risvan
A generic version of RISVAN was approved as risperidone by APOTEX INC on September 15th, 2008.
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Summary for RISVAN
| International Patents: | 182 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Applications: | 2,458 |
| DailyMed Link: | RISVAN at DailyMed |
US Patents and Regulatory Information for RISVAN
RISVAN is protected by fourteen US patents and one FDA Regulatory Exclusivity.
Patents protecting RISVAN
Methods for the preparation of injectable depot compositions
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Antipsychotic injectable depot composition
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Antipsychotic injectable depot composition
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Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
Methods for the preparation of injectable depot compositions
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Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
Risperidone or paliperidone implant formulation
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Antipsychotic Injectable Depot Composition
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Methods for the preparation of injectable depot compositions
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Risperidone or paliperidone implant formulation
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Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS BY INTRAMUSCULAR ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
Risperidone or paliperidone implant formulation
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Patented Use: ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
Antipsychotic injectable depot composition
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Patented Use: INTRAMUSCULAR ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
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Patented Use: ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
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Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS BY INTRAMUSCULAR ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
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Patented Use: INTRAMUSCULAR ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
FDA Regulatory Exclusivity protecting RISVAN
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Labs Farms Rovi Sa | RISVAN | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 214835-002 | Mar 29, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Labs Farms Rovi Sa | RISVAN | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 214835-002 | Mar 29, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Labs Farms Rovi Sa | RISVAN | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 214835-001 | Mar 29, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for RISVAN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Laboratorios Farmacéuticos Rovi, S.A. | Okedi | risperidone | EMEA/H/C/005406 Treatment 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 RISVAN
See the table below for patents covering RISVAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2014014483 | FORMULACION DE IMPLANTES DE RISPERIDONA O PALIPERIDONA. (RISPERIDONE OR PALIPERIDONE IMPLANT FORMULATION.) | ⤷ Sign Up |
| Ukraine | 113317 | КОМПОЗИЦІЯ ДЛЯ ІН'ЄКЦІЙ | ⤷ Sign Up |
| South Africa | 201409297 | PALIPERIDONE IMPLANT FORMULATION | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RISVAN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0196132 | 94C0008 | Belgium | ⤷ Sign Up | 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. 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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