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INDOCIN

NDA

INDOMETHACIN SODIUM | N018878 | RECORDATI RARE DISEASES INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Fresenius Kabi USA, LLC FDA-2018-P-3666 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition requesting that the FDA designate its Indomethacin Injection approved under 505(b)(2) NDA 022536 as therapeutically equivalent with an AP rating to the reference listed drug Indocin (Indomethacin Sodium Injection, NDA 018878) by Recordati Rare Dise	Other	2018-09-27	Denied	Fresenius Kabi USA, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

102 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 66 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis NCT02205762	Phase 2/3	Active	North American Consortium for Histiocytosis	1,400	2016-11-02 → 2026-07
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)NCT03547232	Phase 4	Recruiting	Peking Union Medical College Hospital	1,504	2024-12-01 → 2028-12-01
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis NCT03713879	Phase 3	Recruiting	Chinese University of Hong Kong	1,734	2019-03-21 → 2026-12-31
Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age NCT02633969	Phase 2	Completed	Iroko Pharmaceuticals, LLC	30	2015-12 → 2017-01
The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress NCT01848665	Phase 4	Completed	Brock University	8	2013-05 → 2016-12
IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity NCT02609386	Phase 2	Completed	Brooklyn ImmunoTherapeutics, LLC	105	2016-01-11 → 2022-02-28
NSAIDs and PGE2 Levels in Vitrectomy Patients NCT02361645	Phase 3	Completed	Università degli Studi di Brescia	70	2014-03 → 2015-01
Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults NCT03712241	Phase 1	Completed	Kowa Research Institute, Inc.	15	2018-10-04 → 2019-01-06
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules NCT00858195	Phase 1	Completed	Sandoz	36	2006-06 → 2006-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

SOLARA ACTIVE PHARMA SCIENCES LTDINDOMETHACIN SODIUM

DMF 227512009

GLAND PHARMA LTDINDOMETHACIN SODIUM USP

DMF 254012011

GLAND PHARMA LTDINDOMETHACIN SODIUM USP

DMF 272822013

FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN SODIUM

DMF 294412015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 30, 2021	SUPPL -29	View Letter (PDF)
Jan 26, 2010	SUPPL -27	View Letter (PDF)
Jan 25, 2007	SUPPL -24	View Letter (PDF)
Feb 8, 2006	SUPPL -23	View Letter (PDF)
May 30, 2003	SUPPL -19	View Letter (PDF)
May 30, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 30, 1985

No patent or exclusivity listings for this strength.