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Last Updated: October 31, 2020

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Tofacitinib - Generic Drug Details

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Generic filers with tentative approvals for TOFACITINIB
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for tofacitinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Baxter
Dow
Colorcon
Moodys

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