Details for New Drug Application (NDA): 211675
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NDA 211675 describes RINVOQ, which is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. There are forty-five patents protecting this drug. Additional details are available on the RINVOQ profile page.
The generic ingredient in RINVOQ is upadacitinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.
The generic ingredient in RINVOQ is upadacitinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.
Summary for 211675
| Tradename: | RINVOQ |
| Applicant: | Abbvie |
| Ingredient: | upadacitinib |
| Patents: | 45 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211675
Generic Entry Date for 211675*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*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.
Pharmacology for NDA: 211675
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 211675
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RINVOQ | upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675 | NDA | AbbVie Inc. | 0074-1043 | 0074-1043-14 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-1043-14) |
| RINVOQ | upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675 | NDA | AbbVie Inc. | 0074-1043 | 0074-1043-28 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-1043-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Aug 16, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 26, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | May 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS | ||||||||
| Regulatory Exclusivity Expiration: | Apr 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH GIANT CELL ARTERITIS | ||||||||
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