Details for New Drug Application (NDA): 203214
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NDA 203214 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.
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 203214
| Tradename: | XELJANZ |
| Applicant: | Pf Prism Cv |
| Ingredient: | tofacitinib citrate |
| Patents: | 1 |
Pharmacology for NDA: 203214
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 203214
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1001 | 0069-1001-01 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01) |
| XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1002 | 0069-1002-01 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 6, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 14, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 8, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | May 30, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 14, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION | ||||||||
Expired US Patents for NDA 203214
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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