Details for New Drug Application (NDA): 211675
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The generic ingredient in RINVOQ is upadacitinib. 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: | 39 |
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: | Aug 16, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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 |
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