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REPAGLINIDE Drug Profile

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When do Repaglinide patents expire, and when can generic versions of Repaglinide launch?

Repaglinide is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Casi Pharms Inc, Mylan, Paddock Llc, Sun Pharm Inds Inc, and Lupin Ltd. and is included in eight NDAs.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

Summary for REPAGLINIDE

US Patents:	0
Applicants:	8
NDAs:	8
Suppliers / Packagers:	8
Bulk Api Vendors:	94
Clinical Trials:	49
Patent Applications:	4,910
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for REPAGLINIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REPAGLINIDE
DailyMed Link:	REPAGLINIDE at DailyMed

See drug prices for REPAGLINIDE

Recent Clinical Trials for REPAGLINIDE

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

Sponsor	Phase
Seattle Genetics, Inc.	Phase 1
Sanofi	Phase 4
University of Palermo	Phase 4

See all REPAGLINIDE clinical trials

Recent Litigation for REPAGLINIDE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. AUROBINDO PHARMA LTD.	2012-02-16
Novo Nordisk v. Paddock Laboratories	2011-10-20
Novo Nordisk Inc. v. Paddock Laboratories, Inc.	2010-05-28

See all REPAGLINIDE litigation

Pharmacology for REPAGLINIDE

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Synonyms for REPAGLINIDE

(-)-Repaglinide

(+)-2-Ethoxy-alpha-(((S)-alpha-isobutyl-o-piperidinobenzyl)carbamoyl)-p-toluic acid

(s)-(+)-2-ethoxy-4-(2-oxo-2-[(alpha-isobutyl-2-piperidinobenzyl)amino]ethyl)-benzoic acid

(S)-(+)-2-Ethoxy-4-[N-[1-(2-piperidinophenyl)-3-methyl-1-butyl]aminocarbonylmethyl]benzoic acid

(S)-2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)-phenyl)butyl)amino)-2-oxoethyl)-benzoic acid

(S)-2-Ethoxy-4-(2-((3-methyl-1-(2-(piperidin-1-yl)phenyl)butyl)amino)-2-oxoethyl)benzoic acid

(S)-2-Ethoxy-4-(2-((methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)-benzoic acid

(S)-2-ethoxy-4-(2-(3-methyl-1-(2-(piperidin-1-yl)phenyl)butylamino)-2-oxoethyl)benzoic acid

(S)-2-Ethoxy-4-[2-[[3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]-2-oxoethyl]benzoic acid

(S)-2-Ethoxy-4-[N-(1-(2-piperidino-phenyl)-3-methyl-1-butyl)-aminocarbonylmethyl]-benzoic acid

(S)-Repaglinide

111GE012

135062-02-1

2-ethoxy-4-({[(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]carbamoyl}methyl)benzoic acid

2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)benzoic acid

2-ethoxy-4-(2-{[(1S)-3-methyl-1-(2-piperidin-1-ylphenyl)butyl]amino}-2-oxoethyl)benzoic acid

2-ethoxy-4-[2-({(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl}amino)-2-oxoethyl]benzoic acid

2-ethoxy-4-[2-[[(1S)-3-methyl-1-(2-piperidin-1-ylphenyl)butyl]amino]-2-oxoethyl]benzoic acid

2-Ethoxy-4-[2-[[(1S)-3-Methyl-1-[2-(1-Piperidinyl)Phenyl]Butyl]Amino]-2-Oxoethyl]Benzoic Acid

2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidyl)phenyl]butyl]amino]-2-oxo-ethyl]benzoic acid

2-Ethoxy-4-{[(S)-3-methyl-1-(2-piperidin-1-yl-phenyl)-butylcarbamoyl]-methyl}-benzoic acid

2-ethoxy-N-(alpha-(2-methyl-1-propyl)-2-piperidinobenzyl)-4-carbamoylmethylbenzoic acid

62R021

668Z8C33LU

AB0013959

AB00514019

AB00514019_10

AB00514019_11

AB00514019-09

AB2000099

AC-726

AC1L24D5

AC1Q5TZW

Actulin

AG-EE 388

AG-EE 388 ZW

AG-EE 623 ZW

AG-EE 623ZW

AG-EE-388

AG-EE-623 ZW

AGEE-623ZW

AJ-45642

AK-59609

AKOS005561792

AM20090697

AN-15576

ANW-63956

API0004049

AX8145505

BC220160

BCP04250

BDBM50153520

Benzoic acid, 2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)-, (S)-

Benzoic acid, 2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]-

BG0514

BIDD:GT0338

BPBio1_001070

BRD-K82846253-001-03-0

BS-1010

BSPBio_000972

C-22512

C07670

C27H36N2O4

CAS-135062-02-1

CC-34234

CCG-101013

CHEBI:8805

CHEMBL1272

CPD000466305

CS-0979

CTK3J7345

D00594

DB00912

DSSTox_CID_3552

DSSTox_GSID_23552

DSSTox_RID_77078

DTXSID3023552

FAEKWTJYAYMJKF-QHCPKHFHSA-N

FT-0631150

GlucoNorm

GTPL6841

HMS1571A14

HMS2051N08

HMS2094C07

HMS2098A14

HMS2231M21

HMS3715A14

HY-15209

I979

KS-00000GU9

LS-38509

MCULE-3611790330

MFCD00906179

MLS000759407

MLS001076684

MLS001424111

MLS006011560

MolPort-003-850-140

NC00263

NCGC00016978-01

NCGC00016978-02

NCGC00016978-04

NCGC00016978-05

NN-623

NovoNorm

NSC-759893

NSC759893

Pharmakon1600-01506035

Prandin

Prandin (TN)

Prandin;GlucoNorm;NovoNorm

Prestwick0_001046

Prestwick1_001046

Prestwick2_001046

Prestwick3_001046

Q-201663

R0179

Reglin

Repaglinida

Repaglinida [INN-Spanish]

Repaglinide (JAN/USP/INN)

Repaglinide [USAN:USP:INN:BAN]

Repaglinide [USAN]

Repaglinide for system suitability, European Pharmacopoeia (EP) Reference Standard

Repaglinide, >=98% (HPLC), solid

Repaglinide, European Pharmacopoeia (EP) Reference Standard

Repaglinide, United States Pharmacopeia (USP) Reference Standard

Repaglinide,(S)

Repaglinidum

Repaglinidum [INN-Latin]

RTC-063882

s1426

SAM001246546

SBI-0206942.P001

SC-17344

SCHEMBL16137

SMP-508

SMR000466305

SPBio_002906

SR-01000759404

SR-01000759404-4

ST24036034

STK629501

Surepost

Surepost (TN)

SW197344-4

TC-063882

Tox21_110721

UNII-668Z8C33LU

W-5210

Z1777729210

ZINC3798537

Paragraph IV (Patent) Challenges for REPAGLINIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
PRANDIN	TABLET;ORAL	repaglinide	020741	2005-02-10

US Patents and Regulatory Information for REPAGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Totowa	REPAGLINIDE	repaglinide	TABLET;ORAL	090008-001	Jan 22, 2014	AB	RX	No	No
Paddock Llc	REPAGLINIDE	repaglinide	TABLET;ORAL	201189-003	Jan 22, 2014	AB	RX	No	No
Boscogen	REPAGLINIDE	repaglinide	TABLET;ORAL	091517-001	Apr 24, 2015	AB	RX	No	No