Details for New Drug Application (NDA): 213871
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NDA 213871 describes CIBINQO, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the CIBINQO profile page.
The generic ingredient in CIBINQO is abrocitinib. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the abrocitinib profile page.
The generic ingredient in CIBINQO is abrocitinib. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the abrocitinib profile page.
Summary for 213871
| Tradename: | CIBINQO |
| Applicant: | Pfizer |
| Ingredient: | abrocitinib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213871
Generic Entry Date for 213871*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 213871
| Mechanism of Action | Janus Kinase Inhibitors P-Glycoprotein Inhibitors |
Suppliers and Packaging for NDA: 213871
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIBINQO | abrocitinib | TABLET;ORAL | 213871 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0235 | 0069-0235-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0235-30) |
| CIBINQO | abrocitinib | TABLET;ORAL | 213871 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0335 | 0069-0335-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 14, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 14, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 9, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 14, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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