Details for New Drug Application (NDA): 218347
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NDA 218347 describes RINVOQ LQ, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the RINVOQ LQ profile page.
The generic ingredient in RINVOQ LQ is upadacitinib. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.
The generic ingredient in RINVOQ LQ is upadacitinib. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.
Summary for 218347
| Tradename: | RINVOQ LQ |
| Applicant: | Abbvie |
| Ingredient: | upadacitinib |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218347
Generic Entry Date for 218347*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 218347
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 218347
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RINVOQ LQ | upadacitinib | SOLUTION;ORAL | 218347 | NDA | AbbVie Inc. | 0074-2320 | 0074-2320-01 | 1 BOTTLE in 1 CARTON (0074-2320-01) / 180 mL in 1 BOTTLE |
| RINVOQ LQ | upadacitinib | SOLUTION;ORAL | 218347 | NDA | AbbVie Inc. | 0074-2320 | 0074-2320-70 | 1 BOTTLE in 1 CARTON (0074-2320-70) / 180 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Apr 26, 2024 | 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 PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Apr 26, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TUMOR NECROSIS FACTOR (TNF) BLOCKERS, AND FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS | ||||||||
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