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Last Updated: January 26, 2020

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Repaglinide - Generic Drug Details

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What are the generic drug sources for repaglinide and what is the scope of freedom to operate?

Repaglinide is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Casi Pharms Inc, Mylan, Paddock Llc, and Sun Pharm Inds Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for repaglinide. Nine suppliers are listed for this compound.

Drug Prices for repaglinide

See drug prices for repaglinide

Recent Clinical Trials for repaglinide

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

SponsorPhase
Seattle Genetics, Inc.Phase 1
SanofiPhase 4
University of PalermoPhase 4

See all repaglinide clinical trials

Recent Litigation for repaglinide

Identify potential future generic entrants

District Court Litigation
Case NameDate
NOVO NORDISK INC. v. AUROBINDO PHARMA LTD.2012-02-16
Novo Nordisk v. Paddock Laboratories2011-10-20
Novo Nordisk Inc. v. Paddock Laboratories, Inc.2010-05-28

See all repaglinide litigation

Pharmacology for repaglinide
Drug ClassGlinide
Mechanism of ActionPotassium 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
Mylan REPAGLINIDE repaglinide TABLET;ORAL 090252-003 Jan 22, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd REPAGLINIDE repaglinide TABLET;ORAL 203820-002 Jan 22, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd REPAGLINIDE repaglinide TABLET;ORAL 203820-003 Jan 22, 2014 AB RX No Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd REPAGLINIDE repaglinide TABLET;ORAL 203820-001 Jan 22, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-003 Dec 22, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Boscogen REPAGLINIDE repaglinide TABLET;ORAL 091517-003 Apr 24, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Boscogen REPAGLINIDE repaglinide TABLET;ORAL 091517-002 Apr 24, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for repaglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-002 Dec 22, 1997   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-003 Dec 22, 1997   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-002 Dec 22, 1997   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-001 Dec 22, 1997   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-003 Dec 22, 1997   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-003 Dec 22, 1997   Start Trial   Start Trial
Gemini Labs Llc PRANDIN repaglinide TABLET;ORAL 020741-002 Dec 22, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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