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Last Updated: November 21, 2024

INDOMETHACIN SODIUM - Generic Drug Details


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What are the generic drug sources for indomethacin sodium and what is the scope of patent protection?

Indomethacin sodium is the generic ingredient in two branded drugs marketed by Recordati Rare, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for indomethacin sodium.

Summary for INDOMETHACIN SODIUM
Recent Clinical Trials for INDOMETHACIN SODIUM

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

SponsorPhase
Ciusss de L'Est de l'Île de MontréalN/A
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityN/A
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all INDOMETHACIN SODIUM clinical trials

US Patents and Regulatory Information for INDOMETHACIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 204118-001 Apr 19, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Navinta Llc INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 206561-001 Jul 19, 2017 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
West-ward Pharms Int INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 078713-001 Jul 16, 2008 AP RX 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

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