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 |
Anatomical Therapeutic Chemical (ATC) Classes for AMLEXANOX
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 | APHTHASOL | amlexanox | PASTE;DENTAL | 020511-001 | Dec 17, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Uluru | AMLEXANOX | amlexanox | PATCH;TOPICAL | 021727-001 | Sep 29, 2004 | 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
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 |