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.
The generic ingredient in RISVAN is risperidone. There are thirty drug master file entries for this compound. Thirty-five 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
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Patent Applications: | 1,176 |
Formulation / Manufacturing: | see details |
DailyMed Link: | RISVAN at DailyMed |
US Patents and Regulatory Information for RISVAN
RISVAN is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting RISVAN
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Exclusivity Expiration: ⤷ Sign Up
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 | 214835-001 | 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 | ||||
>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 |