Details for New Drug Application (NDA): 210730
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NDA 210730 describes OLINVYK, which is a drug marketed by Trevena and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the OLINVYK profile page.
The generic ingredient in OLINVYK is oliceridine. One supplier is listed for this compound. Additional details are available on the oliceridine profile page.
The generic ingredient in OLINVYK is oliceridine. One supplier is listed for this compound. Additional details are available on the oliceridine profile page.
Summary for 210730
| Tradename: | OLINVYK |
| Applicant: | Trevena |
| Ingredient: | oliceridine |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210730
Generic Entry Date for 210730*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 210730
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLINVYK | oliceridine | SOLUTION;INTRAVENOUS | 210730 | NDA | Trevena, Inc. | 71308-011 | 71308-011-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71308-011-10) / 1 mL in 1 VIAL, SINGLE-DOSE (71308-011-01) |
| OLINVYK | oliceridine | SOLUTION;INTRAVENOUS | 210730 | NDA | Trevena, Inc. | 71308-021 | 71308-021-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/ML (1MG/ML) | ||||
| Approval Date: | Oct 30, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 30, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 23, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | MANAGEMENT OF ACUTE PAIN BY INTRAVENOUS INJECTION | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 23, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | MANAGEMENT OF ACUTE PAIN BY INTRAVENOUS INJECTION | ||||||||
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