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  2. ›drugs
  3. ›DICLOFENAC SODIUM
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DICLOFENAC SODIUM

Marketedupdated 3mo ago
by Altaire Pharmaceuticals Inc
Approved
community read0 votes

🐶 often sniffed alongside

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Small molecule drug with a maximum clinical stage of Approval (across all indications), with 6 approved and 20 investigational indications.

all catalysts(10)

approval · 9
Feb 12, 2002
approval
25y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Dec 20, 2007
approval
19y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Mar 19, 2010
approval
16y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Nov 28, 2014
approval
12y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
May 9, 2016
approval
10y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Mar 29, 2021
approval
5y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Apr 28, 2021
approval
5y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Nov 21, 2024
approval
2y ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
Dec 31, 2025
approval
8mo ago
DICLOFENAC SODIUM — FDA approval
DICLOFENAC SODIUM
→
phase 2 initiation · 1
Apr 26, 2026
phase 2 initiation
4mo ago
TianFang Pharmaceutical Co — diclofenac sodium DR (Phase II Trial Initiation)
DICLOFENAC SODIUM
→
view all 10 catalysts →

Trials studying DICLOFENAC SODIUM

  • phase3Counterpain PXM Versus Diclofenac Versus Piroxicamcompletedn=180
  • phase1Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days.completedn=34
  • phase3A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Kneecompletedn=370
  • phase1Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participantscompletedn=74
  • phase4Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalpcompletedn=502
  • phase4A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalpactive not recruitingn=447
  • phase3Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)completedn=516
  • phase4A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)completedn=160
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 22, 2027
218 days

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

patents (24)

  • Aug 9, 2030method-of-use (U-1436)US 85464504.0y
  • Aug 9, 2030method-of-use (U-1436)US 85464504.0y
  • Jul 10, 2029method-of-use (U-1248)US 82170782.9y
  • Jul 10, 2029method-of-use (U-1477)US 82170782.9y
  • Jul 10, 2029method-of-use (U-1477)US 86181642.9y
  • Jul 10, 2029method-of-use (U-1477)US 86181642.9y
  • Jul 10, 2029method-of-use (U-1435)US 87419562.9y
  • Jul 10, 2029method-of-use (U-1435)US 87419562.9y
  • Jul 10, 2029method-of-use (U-1614)US 93705012.9y
  • Jul 10, 2029method-of-use (U-1614)US 93754122.9y
  • Jul 10, 2029method-of-use (U-1614)US 94150292.9y
  • Apr 21, 2028formulationUS 82528381.7y
  • Oct 17, 2027formulationUS 85636131.2y
  • Oct 17, 2027method-of-use (U-1614)US 88718091.2y
  • Oct 17, 2027formulationUS 90669131.2y
  • Oct 17, 2027formulationUS 91015911.2y
  • Oct 17, 2027method-of-use (U-1488)US 91321101.2y
  • Oct 17, 2027formulationUS 91683041.2y
  • Oct 17, 2027method-of-use (U-1488)US 91683051.2y
  • Oct 17, 2027method-of-use (U-1488)US 92207841.2y
  • Oct 17, 2027method-of-use (U-1488)US 93395511.2y
  • Oct 17, 2027formulationUS 93395521.2y
  • Oct 17, 2027method-of-use (U-1614)US 95393351.2y
  • Mar 22, 2027method-of-use (U-1659)US 8946292218d

News(0)

no news has mentioned this drug yet

brand
DICLOFENAC SODIUM
generic
DICLOFENAC SODIUM
MOA
Cyclooxygenase inhibitor
indication
Post-Operative Pain
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 9m ago
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