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  1. pharmadog
  2. ›drugs
  3. ›ISOTRETINOIN
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ISOTRETINOIN

Marketedupdated 4mo ago
by Amneal Pharmaceuticals of New York LLC
Approved
community read0 votes

🐶 often sniffed alongside

top 8
  • tagApproval374 co-mentions · 187 sources
  • drugZENATANE339 co-mentions · 190 sources
  • drugAbsorica220 co-mentions · 190 sources
  • tagSmall Molecule187 co-mentions · 187 sources
  • companyTeva Pharmaceuticals USA Inc4 co-mentions · 2 sources
  • tagRecall3 co-mentions · 3 sources
  • companyMylan Pharmaceuticals Inc2 co-mentions · 1 sources
  • companyAurobindo Pharma Ltd2 co-mentions · 2 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for acne and 21 investigational indications.

all catalysts(21)

approval · 20
Mar 25, 2013
approval
$RDY12.03-1.15%
13y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Feb 23, 2015
approval
$RDY12.03-1.15%
12y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Sep 3, 2015
approval
$RDY12.03-1.15%
11y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Feb 4, 2016
approval
$RDY12.03-1.15%
11y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Jul 8, 2016
approval
$RDY12.03-1.15%
10y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Jun 17, 2017
approval
$RDY12.03-1.15%
9y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Apr 23, 2018
approval
$RDY12.03-1.15%
8y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
May 2, 2018
approval
$RDY12.03-1.15%
8y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Aug 31, 2018
approval
$RDY12.03-1.15%
8y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Nov 16, 2020
approval
$RDY12.03-1.15%
6y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Dec 9, 2020
approval
$RDY12.03-1.15%
6y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Oct 8, 2021
approval
$RDY12.03-1.15%
5y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Nov 9, 2021
approval
$RDY12.03-1.15%
5y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Aug 4, 2022
approval
$RDY12.03-1.15%
4y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Aug 23, 2022
approval
$RDY12.03-1.15%
4y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Oct 6, 2022
approval
$RDY12.03-1.15%
4y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Mar 24, 2023
approval
$RDY12.03-1.15%
3y ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Jan 29, 2024
approval
3y ago
ISOTRETINOIN — FDA approval
ISOTRETINOIN
→
Feb 9, 2026
approval
$RDY12.03-1.15%
7mo ago
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Feb 9, 2026
approval
7mo ago
ISOTRETINOIN — FDA approval
ISOTRETINOIN
→
phase 2 completion · 1
Apr 30, 2026
phase 2 completion
4mo ago
Sun Pharmaceutical Industries Ltd — Absorica (Phase II Trial Completion)
ISOTRETINOIN
→
view all 21 catalysts →

Trials studying ISOTRETINOIN

  • phase2Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathwaynot yet recruitingn=50
  • phase2A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastomacompletedn=59
  • phase2Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)terminatedn=55
  • phase4A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgariscompletedn=31

Patent cliff

source: FDA Orange Book
first barrier falls
May 29, 2035
~8.7 years out

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

patents (12)

  • Aug 4, 2035formulationUS 9700535
  • Aug 4, 2035formulationUS 9700535
  • Aug 4, 2035formulationUS 9700535
  • Aug 4, 2035formulationUS 9700535
  • Aug 4, 2035formulationUS 9700535
  • Aug 4, 2035formulationUS 9700535
  • May 29, 2035formulationUS 9750711
  • May 29, 2035formulationUS 9750711
  • May 29, 2035formulationUS 9750711
  • May 29, 2035formulationUS 9750711
  • May 29, 2035formulationUS 9750711
  • May 29, 2035formulationUS 9750711

News(0)

no news has mentioned this drug yet

brand
ISOTRETINOIN
generic
ISOTRETINOIN
MOA
Retinoic acid receptor agonist
indication
Severe Recalcitrant Nodular Acne
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 1h ago
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