Details for New Drug Application (NDA): 213586
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NDA 213586 describes UZEDY, which is a drug marketed by Teva and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the UZEDY profile page.
The generic ingredient in UZEDY is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
The generic ingredient in UZEDY is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 213586
| Tradename: | UZEDY |
| Applicant: | Teva |
| Ingredient: | risperidone |
| Patents: | 6 |
Suppliers and Packaging for NDA: 213586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586 | NDA | Teva Pharmaceuticals USA, Inc. | 51759-305 | 51759-305-10 | 1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS |
| UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586 | NDA | Teva Pharmaceuticals USA, Inc. | 51759-305 | 51759-305-11 | 1 SYRINGE, GLASS in 1 CARTON (51759-305-11) / .14 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 50MG/0.14ML (50MG/0.14ML) | ||||
| Approval Date: | Apr 28, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 12,128,132 | Patent Expiration: | Sep 11, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF BIPOLAR DISORDER | ||||||||
| Patent: | 12,128,132 | Patent Expiration: | Sep 11, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
Expired US Patents for NDA 213586
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-001 | Apr 28, 2023 | 9,895,447 | ⤷ Start Trial |
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-005 | Apr 28, 2023 | 9,925,268 | ⤷ Start Trial |
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-007 | Apr 28, 2023 | 9,717,799 | ⤷ Start Trial |
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-007 | Apr 28, 2023 | 9,895,447 | ⤷ Start Trial |
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-005 | Apr 28, 2023 | 9,439,905 | ⤷ Start Trial |
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-006 | Apr 28, 2023 | 9,439,905 | ⤷ Start Trial |
| Teva | UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586-007 | Apr 28, 2023 | 9,925,268 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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