TheraRadar
Data updated: May 26, 2026

ADLARITY (donepezil hydrochloride)

CNS Approved 2022-03-11
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Discontinued
First Approved
2022-03-11
Patent Cliff
2038

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Routes
TRANSDERMAL
Dosage Forms
SYSTEM

Companies

CORIUM
Active Ingredient: DONEPEZIL HYDROCHLORIDE

ADLARITY Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2022
Mar 2022 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What ADLARITY Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
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Clinical Trial Registry

11 trials
Trial Sponsor ID Phase Status Title
NCT00688376 results posted E2020-G000-333 E2020-G000-334, 2007-005435-28 Ph 3 completed Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
NCT01466270 results posted IRB00019792-1 U10CA081851, REBACCCWFU 97211 Ph 2 completed Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
NCT00369785 results posted IRB00000551 U10CA081851, REBACCCWFU 91105 Ph 3 completed Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
NCT04013477 DA5207_ADK_Ia Ph 1 completed Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults
NCT02660983 results posted E2020-K082-418 Ph 4 completed A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
NCT01903824 C26401/1111 2013-001883-51 Ph 1 completed Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects
NCT00695136 results posted 080154 08-M-0154 Ph 1, Ph 2 completed The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism
NCT01506752 E2020-J081-034 Ph 1 completed A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
NCT01506739 E2020-J081-033 Ph 1 completed A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males
NCT01504503 645/09 Ph 1 completed Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition
NCT01504516 646-09 Ph 1 completed Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ADLARITY FDA Label Details

View full patent landscape →
11 OB patents · 3 families · 127 international docs across 12 countries

ADLARITY Patents & Exclusivity

Latest Patent: Aug 2038

Patents (11 active)

US10966936 Expires Aug 11, 2038
US10835499 Expires May 20, 2038
US11648214 Expires Sep 23, 2037
US11103463 Expires Jul 26, 2037
US10016372 Expires Jul 26, 2037
US10300025 Expires Jul 26, 2037
US10307379 Expires Jul 26, 2037
US9993466 Expires Jul 26, 2037
US11679086 Expires May 26, 2037
US12161767 Expires Dec 30, 2036
US12168075 Expires Dec 30, 2036
Source: FDA Orange Book

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Deep insights for ADLARITY

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2038
  • • 44 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA212304 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.