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Last Updated: December 3, 2020

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Amlexanox - Generic Drug Details

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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
Bulk Api Vendors: 105
Clinical Trials: 3
Patent Applications: 1,922
DailyMed Link:amlexanox at DailyMed
Recent Clinical Trials for amlexanox

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

SponsorPhase
University of MichiganPhase 2
Advanced Clinical Research Services, LLCPhase 2
Access Pharmaceuticals, Inc.Phase 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   Start Trial   Start Trial   Start Trial
Uluru APHTHASOL amlexanox PASTE;DENTAL 020511-001 Dec 17, 1996 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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Dow
Boehringer Ingelheim
McKesson
AstraZeneca

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