AMLEXANOX - Generic Drug Details

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What are the generic sources for amlexanox and what is the scope of freedom to operate?

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:	124
Clinical Trials:	3
Patent Applications:	3,043
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	AMLEXANOX	amlexanox	PATCH;TOPICAL	021727-001	Sep 29, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Uluru	APHTHASOL	amlexanox	PASTE;DENTAL	020511-001	Dec 17, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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