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Last Updated: March 28, 2024

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

SponsorPhase
University of MichiganPhase 2
Access Pharmaceuticals, Inc.Phase 2
Advanced Clinical Research Services, LLCPhase 2

See all amlexanox clinical trials

US Patents and Regulatory Information for amlexanox

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uluru APHTHASOL amlexanox PASTE;DENTAL 020511-001 Dec 17, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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