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Indomethacin - Generic Drug Details

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

Indomethacin is the generic ingredient in six branded drugs marketed by Iroko Pharms, Able, Amneal Pharms, Aurobindo Pharma Ltd, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan Pharms Inc, Novast Labs Ltd, Sandoz, Watson Labs Inc, Zydus Pharms Usa Inc, Teva, Iroko Pharms Llc, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage Pharms Inc, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Parke Davis, Pioneer Pharms, Pliva, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs, Fresenius Kabi Usa, G And W Labs, Recordati Rare, Hospira Inc, Navinta Llc, and West-ward Pharms Int, and is included in seventy NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indomethacin has thirty-four patent family members in twenty countries.

There are fifteen drug master file entries for indomethacin. Fifty-five suppliers are listed for this compound.

Summary for indomethacin

International Patents:	34
US Patents:	3
Tradenames:	6
Applicants:	39
NDAs:	70
Drug Master File Entries:	15
Suppliers / Packagers:	55
Bulk Api Vendors:	110
Clinical Trials:	120
Patent Applications:	6,910
Formulation / Manufacturing:	see details
DailyMed Link:	indomethacin at DailyMed

Pharmacology for indomethacin

Ingredient-type	Nonsteroidal Anti-inflammatory Compounds
Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for indomethacin

Anti-Inflammatory Agents, Non-Steroidal

Cardiovascular Agents

Cyclooxygenase Inhibitors

Gout Suppressants

Tocolytic Agents

Synonyms for indomethacin

.alpha.-(1-(p-Chlorobenzoyl)-2-methyl-5-methoxy-3-indolyl)acetic acid

(1-p-Chlorobenzoyl-5-methoxy-2-methylindol-3-yl)acetic acid

[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid

[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid #

[1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic acid

{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1H-indol-3-yl}acetic acid

1-?(4-?CHLOROBENZOYL)-?5-?METHOXY-?2-?METHYL-?1H-?INDOLE-?3-?ACETIC ACID

1-(4-chloro-benzoyl)-5-methoxy-2-methyl-3-indolyl-acetic acid

1-(4-Chlorobenzoyl)-2-methyl-5-methoxyindole-3-acetic acid

1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid

1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid & MAP-30

1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-3-indoleacetic acid

1-(4-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid

1-(p-Chlorbenzoyl)-5-methoxy-2-methylindol-3-essigsaeure

1-(p-Chlorbenzoyl)-5-methoxy-2-methylindol-3-essigsaeure [German]

1-(p-Chlorobenzoyl)-2-methoxy-3-methyl-1H-indole-3-acetic Acid

1-(p-Chlorobenzoyl)-2-methyl-5-methoxy-3-indole-acetic acid

1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indoleacetic acid

1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indolylacetic acid

1-(p-Chlorobenzoyl)-2-methyl-5-methoxyindole-3-acetic acid

1-(p-chlorobenzoyl)-5-methoxy-2-methyl-3-indol acetic acid

1-(p-chlorobenzoyl)-5-methoxy-2-methyl-3-indoleacetic acid

1-(p-chlorobenzoyl)-5-methoxy-2-methyl-3-indolylacetic acid

1-(p-Chlorobenzoyl)-5-methoxy-2-methylindol-3-acetic acid

1-(p-Chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid

1-[p-Chlorobenzoyl]-5-methoxy-2-methylindole-3-acetic acid

1-p-chlorobenzoyl-2-methyl-5-methoxyindol-3-acetic acid

1-p-Cloro-benzoil-5-metoxi-2-metilindol-3-acido acetico

1-p-Cloro-benzoil-5-metoxi-2-metilindol-3-acido acetico [Spanish]

1H-Indole-3-acetic acid, 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-

1H-Indole-3-acetic acid, 1-(4-chlorobenzoyl)-5-methoxy-2-methyl- (9CI)

1z9h

2-(1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl)acetic acid

2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid

2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-indol-3-yl]acetic acid

2-[1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic acid

2-{1-((4-chlorophenyl)carbonyl)-5-methoxy-2-methylindol-3-yl}acetic acid

2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2 methylindol-3-yl}acetic acid

2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1h-indol-3-yl}acetic acid

2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methylindol-3-yl}acetic acid

2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2methylindol-3-yl}acetic acid

37242-43-6

4kyk

5-22-05-00239 (Beilstein Handbook Reference)

503560-73-4

53-86-1

74252-25-8 (hydrochloride salt, tri-hydrate)

7681-54-1 (hydrochloride salt)

87377-08-0

91853-74-6

AB00052022

AB00052022_23

AB00052022_24

AB00052022-20

AB00052022-21

AB1009492

AC-532

AC1L1GJQ

Aconip

Aconip (TN)

ACT02579

AJ-23672

AK162413

AKOS000592893

alpha-(1-(p-Chlorobenzoyl)-2-methyl-5-methoxy-3-indolyl)acetic acid

Amuno

AN-15738

ANW-42683

Apo-Indomethacin

ARONIS27005

Arthrexin

Artracin

Artrinovo

Artrivia

BC203259

BDBM17638

BIDD:GT0132

BIM-0050670.0001

Bio-0704

Bio2_000405

Bio2_000885

Bonidin

Bonidon

Bonidon Gel

BP-30207

BPBio1_000160

BRD-K57222227-001-06-1

BRN 0497341

BSPBio_000144

BSPBio_001149

BSPBio_002176

C01926

CAS-53-86-1

Catlep

CCG-40186

CCRIS 3502

CGIGDMFJXJATDK-UHFFFAOYSA-

CGIGDMFJXJATDK-UHFFFAOYSA-N

CHEBI:49662

CHEMBL6

Chibro-amuno

Chrono-indicid

Chrono-indocid

Confortid

CS-2242

CTK3J2195

D00141

D0R1RS

DB00328

DivK1c_000271

Dolcidium

Dolcidium PL

Dolovin

DR001870

DSSTox_CID_740

DSSTox_GSID_20740

DSSTox_RID_75763

DTXSID9020740

Durametacin

EINECS 200-186-5

Elmetacin

EU-0100692

Flexin continus

FT-0603227

GTPL1909

H911

HE226516

HE350057

Hicin

HMS1362I11

HMS1568H06

HMS1792I11

HMS1920F21

HMS1990I11

HMS2089N19

HMS2091N09

HMS2095H06

HMS2231J10

HMS3262K05

HMS3268A14

HMS3374F07

HMS3403I11

HMS3430L03

HMS3649K17

HMS3655O04

HMS500N13

HSDB 3101

HY-14397

I 7378

I0655

IDI1_000271

IDI1_002160

Idomethine

Imbrilon

IMN

IN1454

Inacid

InChI=1/C19H16ClNO4/c1-11-15(10-18(22)23)16-9-14(25-2)7-8-17(16)21(11)19(24)12-3-5-13(20)6-4-12/h3-9H,10H2,1-2H3,(H,22,23)

Indacin

Indameth

Indmethacine

Indo-Lemmon

Indo-phlogont

Indo-rectolmin

Indo-Spray

Indo-tablinen

Indochron E-R

Indochron E-R (TN)

Indocid

Indocid (pharmaceutical)

Indocid (TN)

Indocid Pda

Indocid Sr

Indocin

Indocin (TN)

Indocin I.V

Indocin I.V.

Indocin Sr

Indocin-SR

Indocin-SR (TN)

Indocollyre

Indolar SR

Indole-3-acetic acid, 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-

Indole-3-acetic acid, 1-(p-chlorobenzoyl)-5-methoxy-2-methyl- (8CI)

Indomecol

Indomed

Indomee

Indomet 140

indometacin

Indometacin (JP15/INN)

Indometacin (JP17/INN)

Indometacin [INN]

Indometacin 1.0 mg/ml in Acetonitrile

Indometacina

Indometacina [INN-Spanish]

Indometacine

Indometacine [INN-French]

Indometacinum

Indometacinum [INN-Latin]

Indometacyna

Indometacyna [Polish]

Indomethacin (Indocid, Indocin)

Indomethacin (USP)

Indomethacin [USAN:BAN]

Indomethacin [USAN:USP]

Indomethacin & MAP-30

indomethacin HCl

Indomethacin Hydrochloride

Indomethacin, >=99.0% (TLC)

Indomethacin, >=99% (TLC)

Indomethacin, 98% 5g

Indomethacin, Antibiotic for Culture Media Use Only

Indomethacin, European Pharmacopoeia (EP) Reference Standard

Indomethacin, Indochron E-R, Indocin-SR, Indocid, Indocin, Indomethacin

Indomethacin, meets USP testing specifications

Indomethacin, pharmaceutical secondary standard; traceable to USP and PhEur

Indomethacin, United States Pharmacopeia (USP) Reference Standard

Indomethacine

Indomethacinum

Indomethancin

Indomethazine

Indomethegan

Indomethine

Indometicina

Indometicina [Spanish]

Indomo

Indomod

Indonol

Indoptic

Indoptol

Indorektal

Indoxen

Inflazon

Infrocin

Innamit

Inteban

Inteban sp

J10170

KB-74685

KBio1_000271

KBio2_000489

KBio2_001399

KBio2_003057

KBio2_003967

KBio2_005625

KBio2_006535

KBio3_000897

KBio3_000898

KBio3_001396

KBioGR_000395

KBioGR_000489

KBioSS_000489

KBioSS_001399

KS-00000WRK

KS-000048I8

KS-5255

KSC492C9L

Kwas 1-(p-chlorobenzoilo)-2-metylo-5-metoksy-3-indolilooctowy

Kwas 1-(p-chlorobenzoilo)-2-metylo-5-metoksy-3-indolilooctowy [Polish]

L000959

Lausit

Liometacen

Lopac-I-7378

Lopac0_000692

LP00692

LS-187

LS-82147

MCULE-5636486088

Metacen

Metartril

Methazine

Metindol

Mezolin

MFCD00057095

Miametan

Mikametan

MLS000069402

MLS001074194

MLS006011845

Mobilan

MolMap_000032

MolPort-000-917-894

N-(p-Chlorobenzoyl)-2-methyl-5-methoxy-3-indolylacetic acid

N-p-Chlorbenzoyl-5-methoxy-2-methylindole-3-acetic acid

NCGC00015562-01

NCGC00015562-02

NCGC00015562-03

NCGC00015562-04

NCGC00015562-05

NCGC00015562-06

NCGC00015562-07

NCGC00015562-08

NCGC00015562-09

NCGC00015562-10

NCGC00015562-11

NCGC00015562-12

NCGC00015562-13

NCGC00015562-14

NCGC00015562-15

NCGC00015562-16

NCGC00015562-17

NCGC00015562-18

NCGC00015562-19

NCGC00015562-20

NCGC00015562-21

NCGC00015562-22

NCGC00015562-24

NCGC00015562-25

NCGC00024135-02

NCGC00024135-04

NCGC00024135-05

NCGC00024135-06

NCGC00024135-07

NCGC00024135-08

NCGC00024135-09

NCGC00024135-10

NCGC00024135-11

NCGC00024135-12

NCGC00024135-13

NCGC00024135-14

NCGC00024135-15

NCGC00254075-01

NCGC00259340-01

NCGC00261377-01

NCI-C56144

NCI60_041708

NE11089

NINDS_000271

Novo-Methacin

Novomethacin

NSC-757061

NSC757061

Nu-Indo

Opera_ID_56

Oprea1_686105

Osmosin

Pharmakon1600-01500350

Prestwick_597

Prestwick0_000272

Prestwick1_000272

Prestwick2_000272

Prestwick3_000272

PubChem17620

Q-201239

Reumacide

Rhemacin LA

Rheumacin LA

RTR-019032

S00108

s1723

Sadoreum

SBB057417

SBI-0050670.P004

SC-17536

SCHEMBL9300

SMR000058195

SPBio_000979

SPBio_002363

Spectrum_000919

SPECTRUM1500350

Spectrum2_000970

Spectrum3_000468

Spectrum4_000018

Spectrum5_000868

SR-01000000014

SR-01000000014-16

ST24039048

ST50320042

STL257874

Tannex

Tocris-1708

Tox21_113109

Tox21_113109_1

Tox21_201791

Tox21_300266

Tox21_500692

TR-019032

UNII-XXE1CET956

UPCMLD-DP023

UPCMLD-DP023:001

USAN

Vonum

XXE1CET956

Z56784896

ZINC601283

US Patents and Regulatory Information for indomethacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	200529-001	Nov 30, 2010	AB	RX	No	No
Ivax Sub Teva Pharms	INDOMETHACIN	indomethacin	CAPSULE;ORAL	018730-002	May 4, 1984		DISCN	No	No
Pliva	INDOMETHACIN	indomethacin	CAPSULE;ORAL	071148-001	Mar 18, 1987		DISCN	No	No
Glenmark Pharms Ltd	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	203501-001	Jun 22, 2017	AB	RX	No	No

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Expired US Patents for indomethacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Iroko Pharms	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982
Iroko Pharms	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984
Iroko Pharms	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984

Non-Orange Book US Patents for indomethacin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,095,496	Formulation of indomethacin
9,522,135	Formulation of indomethacin
9,849,111	Formulation of indomethacin

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International Patents for indomethacin

Country	Document Number	Estimated Expiration
Ukraine	106231
Australia	2016200397
China	102438594
European Patent Office	2421513