Last Updated: November 9, 2026

Amlexanox - Generic Drug Details

Name: amlexanox Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for amlexanox and what is the scope of patent protection?

Amlexanox is the generic ingredient in two branded drugs marketed by Uluru and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for amlexanox

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	3
Patent Applications:	3,307
DailyMed Link:	amlexanox at DailyMed

Recent Clinical Trials for amlexanox

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Michigan	Phase 2
Access Pharmaceuticals, Inc.	Phase 2
Advanced Clinical Research Services, LLC	Phase 2

See all amlexanox clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for amlexanox

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

R03DX	Other systemic drugs for obstructive airway diseases
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for amlexanox

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Uluru	APHTHASOL	amlexanox	PASTE;DENTAL	020511-001	Dec 17, 1996		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Uluru	AMLEXANOX	amlexanox	PATCH;TOPICAL	021727-001	Sep 29, 2004		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for amlexanox

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Uluru	APHTHASOL	amlexanox	PASTE;DENTAL	020511-001	Dec 17, 1996	5,362,737	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.