drug
apremilast
Marketedupdated 5mo agoby Annora Pharma Pvt Ltd
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 8- drugOTEZLA31 co-mentions · 17 sources
- tagApproval28 co-mentions · 14 sources
- drugapremilast ER17 co-mentions · 17 sources
- tagSmall Molecule14 co-mentions · 14 sources
- company$AMGNAMGEN INC14 co-mentions · 14 sources
- companyUniversity of Colorado Denver1 co-mentions · 1 sources
- companyUniversity of California Los Angeles1 co-mentions · 1 sources
- companyUniversity of Virginia1 co-mentions · 1 sources
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 6 approved and 23 investigational indications.
all catalysts(14)
approval · 14
Mar 21, 2014
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Jul 22, 2014
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Jul 28, 2014
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Sep 19, 2014
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Apr 27, 2015
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Dec 21, 2015
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Jun 29, 2017
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Jul 19, 2019
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Apr 10, 2020
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Dec 20, 2021
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Jul 20, 2023
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Apr 25, 2024
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
→
Jul 23, 2025
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
→
Dec 23, 2025
approval
$AMGN403.04-1.04%
OTEZLA (APREMILAST) — FDA approval
apremilast
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Trials studying apremilast
- phase4Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
- phase3A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
- phase3A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
- phase3A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
- phase3A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
- phase3HPP737 in Adult Patients With Plaque Psoriasis
- phase3Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
- phase3A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 19, 2027
107 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (23)
- May 27, 2042formulationUS 11752129
- May 27, 2042formulationUS 11969409
- May 27, 2042method-of-use (U-4291)US 12427136
- Nov 29, 2034patentUS 10092541*PED
- Nov 29, 2034patentUS 10092541*PED
- Nov 29, 2034patentUS 10092541*PED
- Nov 29, 2034patentUS 9872854*PED
- Nov 29, 2034patentUS 9872854*PED
- Nov 29, 2034patentUS 9872854*PED
- May 29, 2034method-of-use (U-2659)US 10092541
- May 29, 2034method-of-use (U-2659)US 10092541
- May 29, 2034method-of-use (U-2659)US 10092541
- May 29, 2034method-of-use (U-2403)US 10092541
- May 29, 2034method-of-use (U-2233)US 9872854
- May 29, 2034method-of-use (U-2233)US 9872854
- May 29, 2034method-of-use (U-2233)US 9872854
- Aug 16, 2028patentUS 7427638*PED1.9y
- Aug 16, 2028patentUS 7427638*PED1.9y
- Aug 16, 2028patentUS 7427638*PED1.9y
- Feb 16, 2028compositionUS 74276381.4y
- Feb 16, 2028compositionUS 74276381.4y
- Feb 16, 2028compositionUS 74276381.4y
- Feb 16, 2028compositionUS 74276381.4y
FDA exclusivities (22)
- Oct 25, 2027PEDPediatric (6mo bonus)1.1y
- Oct 25, 2027PEDPediatric (6mo bonus)1.1y
- Oct 25, 2027PEDPediatric (6mo bonus)1.1y
- Apr 25, 2027NPPNew Product (3y)203d
- Apr 25, 2027NPPNew Product (3y)203d
- Apr 25, 2027NPPNew Product (3y)203d
- Jan 20, 2027PEDPediatric (6mo bonus)108d
- Jan 20, 2027PEDPediatric (6mo bonus)108d
- Jan 20, 2027PEDPediatric (6mo bonus)108d
- Jan 20, 2027PEDPediatric (6mo bonus)108d
- Jan 19, 2027PEDPediatric (6mo bonus)107d
- Jan 19, 2027PEDPediatric (6mo bonus)107d
- Jan 19, 2027PEDPediatric (6mo bonus)107d
- Jan 19, 2027PEDPediatric (6mo bonus)107d
- Jul 20, 2026M-299Method (3y)
- Jul 20, 2026M-299Method (3y)
- Jul 20, 2026M-299Method (3y)
- Jul 20, 2026M-299Method (3y)
- Jul 19, 2026ODE-248Orphan Drug (7y)
- Jul 19, 2026ODE-248Orphan Drug (7y)
- Jul 19, 2026ODE*ODE*
- Jul 19, 2026ODE-248Orphan Drug (7y)
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