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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213082


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NDA 213082 describes XELJANZ, which is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XELJANZ profile page.

The generic ingredient in XELJANZ is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
Summary for 213082
Tradename:XELJANZ
Applicant:Pfizer
Ingredient:tofacitinib citrate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 213082
Mechanism of ActionJanus Kinase Inhibitors
Suppliers and Packaging for NDA: 213082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XELJANZ tofacitinib citrate SOLUTION;ORAL 213082 NDA Pfizer Laboratories Div Pfizer Inc 0069-1029 0069-1029-02 1 BOTTLE in 1 CARTON (0069-1029-02) / 240 mL in 1 BOTTLE (0069-1029-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 1MG BASE/ML
Approval Date:Sep 25, 2020TE:AARLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 8, 2025Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 213082

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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