Details for New Drug Application (NDA): 210655
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The generic ingredient in PERSERIS KIT 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 210655
| Tradename: | PERSERIS KIT |
| Applicant: | Indivior |
| Ingredient: | risperidone |
| Patents: | 10 |
Medical Subject Heading (MeSH) Categories for 210655
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 90MG | ||||
| Approval Date: | Jul 27, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,010,612 | Patent Expiration: | Feb 13, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,058,554 | Patent Expiration: | Sep 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADMINISTRATION OF RISPERIDONE | ||||||||
| Patent: | 10,376,590 | Patent Expiration: | Feb 13, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING SCHIZOPHRENIA | ||||||||
Expired US Patents for NDA 210655
| 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 | 10,406,160 | ⤷ Start Trial |
| Indivior | PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655-002 | Jul 27, 2018 | 10,406,160 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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