Details for New Drug Application (NDA): 208246
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NDA 208246 describes XELJANZ XR, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XELJANZ XR profile page.
The generic ingredient in XELJANZ XR 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 XR 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 208246
| Tradename: | XELJANZ XR |
| Applicant: | Pfizer |
| Ingredient: | tofacitinib citrate |
| Patents: | 4 |
Pharmacology for NDA: 208246
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 208246
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0501 | 0069-0501-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30) |
| XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0502 | 0069-0502-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 11MG BASE | ||||
| Approval Date: | Feb 23, 2016 | 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: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98 | ||||||||
Expired US Patents for NDA 208246
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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