risvan Drug Patent Profile
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When do Risvan patents expire, and what generic alternatives are available?
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
NEW PRODUCT
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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 | ||||
Labs Farms Rovi Sa | RISVAN | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 214835-002 | Mar 29, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
>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 |
Montenegro | 02501 | ANTIPSIHOTICKA INJEKTABILNA DEPONUJUCA KOMPOZICIJA (ANTIPSYCHOTIC INJECTABLE DEPOT COMPOSITION) | ⤷ Sign Up |
San Marino | T201400044 | Formulazione di impianto di paliperidone | ⤷ 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 |