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Last Updated: March 28, 2024

Aminosalicylic acid - Generic Drug Details


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What are the generic drug sources for aminosalicylic acid and what is the scope of freedom to operate?

Aminosalicylic acid is the generic ingredient in three branded drugs marketed by Eurocept Pharms, Panray, and Bristol Myers Squibb, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for aminosalicylic acid.

Summary for aminosalicylic acid
US Patents:0
Tradenames:3
Applicants:3
NDAs:3
Drug Master File Entries: 15
Raw Ingredient (Bulk) Api Vendors: 151
Clinical Trials: 28
Patent Applications: 6,610
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in aminosalicylic acid?aminosalicylic acid excipients list
DailyMed Link:aminosalicylic acid at DailyMed
Recent Clinical Trials for aminosalicylic acid

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

SponsorPhase
Tanta UniversityEarly Phase 1
Assistance Publique - Hôpitaux de ParisPhase 1/Phase 2
Sanjay Gandhi Postgraduate Institute of Medical SciencesPhase 2

See all aminosalicylic acid clinical trials

Medical Subject Heading (MeSH) Categories for aminosalicylic acid

US Patents and Regulatory Information for aminosalicylic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Panray PARASAL aminosalicylic acid TABLET;ORAL 006811-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Panray PARASAL aminosalicylic acid TABLET;ORAL 006811-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REZIPAS aminosalicylic acid resin complex POWDER;ORAL 009052-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eurocept Pharms PASER aminosalicylic acid GRANULE, DELAYED RELEASE;ORAL 074346-001 Jun 30, 1994 RX No Yes ⤷  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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