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NDA

INDOMETHACIN | N204768 | GENUS LIFESCIENCES INC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

Today

8734847

Apr. 23, 2030

8992982

Apr. 23, 2030

9089471

Apr. 23, 2030

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

No clinical trials found on ClinicalTrials.gov for this drug

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

5 letters from Drugs@FDA

Date	Submission	Document
Apr 30, 2021	SUPPL -8	View Letter (PDF)
Mar 28, 2019	SUPPL -6	View Letter (PDF)
May 10, 2016	SUPPL -3	View Letter (PDF)
May 10, 2016	SUPPL -4	View Letter (PDF)
Feb 26, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

RLD

3 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 24, 2014

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8734847	Apr 23, 2030	—	—	Yes	—	—
8992982	Apr 23, 2030	—	—	Yes	—	—
9089471	Apr 23, 2030	—	—	—		—

#002 — 40MG

RLD

3 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 24, 2014