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INDOMETHACIN

NDA

INDOMETHACIN | N018829 | CHARTWELL MOLECULES LLC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.0986

per ea

Lowest NADAC/Unit

$0.0986

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62135006718INDOMETHACIN 25 MG CAPSULE	$0.0986	EA	Generic	—	2026-06-17
62135006790INDOMETHACIN 25 MG CAPSULE	$0.0986	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain6 active DMFs6 inactive

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

FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN

DMF 31361978

MACLEODS PHARMACEUTICALS LTDINDOMETHACIN

DMF 217402008

CSPC OUYI PHARMACEUTICAL CO LTDINDOMETHACIN

DMF 219842008

HETERO DRUGS LTDINDOMETHACIN

DMF 363642021

AURORE LIFE SCIENCES PRIVATE LTDINDOMETHACIN USP

DMF 367612022

AGNO PHARMAINDOMETHACIN USP

DMF 376382024

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveINDOMETHACIN

DMF 26331976

ESTEVE QUIMICA SAInactiveINDOMETHACIN FOR HUMAN USE

DMF 42201981

SIGMA F AND D DIV LTDInactiveINDOMETHACIN

DMF 52581983

EURAND AMERICA INCInactiveINDOMETHACIN

DMF 59781985

SHANGHAI NO 17 PHARMACEUTICAL FACTORYInactiveINDOMETHACIN

DMF 74941988

GUANGDONG PHARMACEUTICAL FACTORYInactiveINDOMETHACIN

DMF 85811990

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -25	View Letter (PDF)
Apr 29, 2021	SUPPL -23	View Letter (PDF)
May 11, 2016	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 6, 1984

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 6, 1984