drug
ISOTRETINOIN
Marketedupdated 4mo agoby Amneal Pharmaceuticals of New York LLC
Approvedcommunity 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%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Feb 23, 2015
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Sep 3, 2015
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Feb 4, 2016
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Jul 8, 2016
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Jun 17, 2017
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Apr 23, 2018
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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May 2, 2018
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Aug 31, 2018
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Nov 16, 2020
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Dec 9, 2020
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Oct 8, 2021
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Nov 9, 2021
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Aug 4, 2022
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Aug 23, 2022
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Oct 6, 2022
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
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Mar 24, 2023
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Jan 29, 2024
approval
ISOTRETINOIN — FDA approval
ISOTRETINOIN
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Feb 9, 2026
approval
$RDY12.03-1.15%
ZENATANE (ISOTRETINOIN) — FDA approval
ISOTRETINOIN
→
Feb 9, 2026
approval
ISOTRETINOIN — FDA approval
ISOTRETINOIN
→
Trials studying ISOTRETINOIN
- phase2Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
- phase2A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma
- phase2Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)
- phase4A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris
Patent cliff
source: FDA Orange Bookfirst 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
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