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. Four 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. Four 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: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try for Free | Patent Expiration: | Sep 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try for Free | Patent Expiration: | Sep 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try for Free | Patent Expiration: | Jun 8, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | 208246-002 | Dec 12, 2019 | ⤷ Try for Free | ⤷ Try for Free |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | ⤷ Try for Free | ⤷ Try for Free |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | ⤷ Try for Free | ⤷ Try for Free |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | ⤷ Try for Free | ⤷ Try for Free |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | ⤷ Try for Free | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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