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  1. pharmadog
  2. ›drugs
  3. ›Tofacitinib Citrate
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tofacitinib citrate ER

Marketedupdated 3mo ago
by Biocon Pharma Ltd
Approved
community read0 votes

🐶 often sniffed alongside

top 8
  • tagApproval120 co-mentions · 60 sources
  • drugTOFACITINIB CITRATE111 co-mentions · 60 sources
  • drugXELJANZ XR111 co-mentions · 60 sources
  • drugXELJANZ111 co-mentions · 60 sources
  • drugtofacitinib60 co-mentions · 60 sources
  • tagSmall Molecule60 co-mentions · 60 sources
  • drugtofacitinib ER60 co-mentions · 60 sources
  • companyAjanta Pharma Ltd7 co-mentions · 7 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for rheumatoid arthritis and psoriatic arthritis and 4 investigational indications.

indications

investigational
IBD (Crohn's + UC)Rheumatoid Arthritis

all catalysts(32)

approval · 32
Feb 23, 2016
approval
$PFE26.61-0.73%
10y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Aug 22, 2017
approval
$PFE26.61-0.73%
9y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Aug 22, 2017
approval
$PFE26.61-0.73%
9y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Dec 14, 2017
approval
$PFE26.61-0.73%
9y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Aug 17, 2018
approval
$PFE26.61-0.73%
8y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Oct 18, 2018
approval
$PFE26.61-0.73%
8y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Jul 25, 2019
approval
$PFE26.61-0.73%
7y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Aug 30, 2019
approval
$PFE26.61-0.73%
7y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Dec 12, 2019
approval
$PFE26.61-0.73%
7y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Sep 25, 2020
approval
$PFE26.61-0.73%
6y ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Jun 1, 2021
approval
5y ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Dec 2, 2021
approval
$PFE26.61-0.73%
5y ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Dec 2, 2021
approval
$PFE26.61-0.73%
5y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Dec 14, 2021
approval
$PFE26.61-0.73%
5y ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Dec 14, 2021
approval
$PFE26.61-0.73%
5y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
May 14, 2024
approval
$PFE26.61-0.73%
2y ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
May 14, 2024
approval
$PFE26.61-0.73%
2y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Sep 27, 2024
approval
$PFE26.61-0.73%
2y ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Sep 27, 2024
approval
$PFE26.61-0.73%
2y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Feb 21, 2025
approval
$PFE26.61-0.73%
1y ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Feb 21, 2025
approval
$PFE26.61-0.73%
1y ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Sep 30, 2025
approval
$SIGY0.04000.00%
11mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Oct 16, 2025
approval
$PFE26.61-0.73%
10mo ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Nov 17, 2025
approval
9mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Feb 18, 2026
approval
6mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Feb 18, 2026
approval
6mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Feb 18, 2026
approval
6mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Feb 18, 2026
approval
6mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Feb 18, 2026
approval
6mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
Mar 6, 2026
approval
$PFE26.61-0.73%
5mo ago
XELJANZ (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Mar 6, 2026
approval
$PFE26.61-0.73%
5mo ago
XELJANZ XR (TOFACITINIB CITRATE) — FDA approval
tofacitinib citrate ER
→
Mar 20, 2026
approval
5mo ago
TOFACITINIB CITRATE — FDA approval
tofacitinib citrate ER
→
view all 32 catalysts →

Trials studying tofacitinib citrate ER

  • phase2A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritisnot yet recruitingn=156
  • phase2Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitiscompletedn=40
  • phase2Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.completedn=180

Patent cliff

source: FDA Orange Book
first barrier falls
Feb 21, 2028
~1.5 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (18)

  • Sep 14, 2034patentUS 10639309*PED
  • Sep 14, 2034patentUS 11253523*PED
  • Sep 14, 2034patentUS 11253523*PED
  • Sep 14, 2034patentUS 9937181*PED
  • Mar 14, 2034formulationUS 10639309
  • Mar 14, 2034method-of-use (U-3329)US 11253523
  • Mar 14, 2034method-of-use (U-3329)US 11253523
  • Mar 14, 2034formulationUS 9937181
  • Jun 8, 2026patentUS RE41783*PED
  • Jun 8, 2026patentUS RE41783*PED
  • Jun 8, 2026patentUS RE41783*PED
  • Jun 8, 2026patentUS RE41783*PED
  • Jun 8, 2026patentUS RE41783*PED
  • Dec 8, 2025compositionUS RE41783
  • Dec 8, 2025compositionUS RE41783
  • Dec 8, 2025compositionUS RE41783
  • Dec 8, 2025compositionUS RE41783
  • Dec 8, 2025compositionUS RE41783

FDA exclusivities (4)

  • Aug 21, 2028PEDPediatric (6mo bonus)2.0y
  • Aug 21, 2028PEDPediatric (6mo bonus)2.0y
  • Feb 21, 2028M-14Method (3y)1.5y
  • Feb 21, 2028M-14Method (3y)1.5y

News(0)

no news has mentioned this drug yet

brand
Tofacitinib Citrate
generic
tofacitinib citrate
MOA
Janus Kinase (JAK) inhibitor
indication
Ankylosing Spondylitis (Bekhterev's Disease)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 47m ago
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