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PRANDIN Drug Profile

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Which patents cover Prandin, and when can generic versions of Prandin launch?

Prandin is a drug marketed by Gemini Labs Llc and is included in one NDA.

The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

Summary for PRANDIN

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	4
Bulk Api Vendors:	83
Patent Applications:	4,232
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	PRANDIN at DailyMed

Pharmacology for PRANDIN

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Synonyms for PRANDIN

(-)-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)-(+)-Repaglinide

(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-[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

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

Bio-0087

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

D0N5YA

DB00912

DR002802

DSSTox_CID_3552

DSSTox_GSID_23552

DSSTox_RID_77078

DTXSID3023552

enyglid

FAEKWTJYAYMJKF-QHCPKHFHSA-N

FT-0631150

Glaxo Wellcome brand of replaginide

GlucoNorm

GlucoNorm (TN)

GTPL6841

HE307690

HMS1571A14

HMS2051N08

HMS2094C07

HMS2098A14

HMS2231M21

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

Novo Nordisk brand 2 of repaglinide

Novo Nordisk brand of repaglinide

NovoNorm

NovoNorm (TN)

NSC-759893

NSC759893

Pharmakon1600-01506035

Prandin (TN)

Prandin, GlucoNorm, NovoNorm, Repaglinide

Prandin;GlucoNorm;NovoNorm

Prestwick0_001046

Prestwick1_001046

Prestwick2_001046

Prestwick3_001046

Q-201663

R0179

Reglin

repa-glinide

Repaglinida

Repaglinida [INN-Spanish]

Repaglinide

Repaglinide (JAN/USP/INN)

Repaglinide [USAN:USP:INN:BAN]

Repaglinide [USAN]

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

repaglinide, (+-)-isomer

Repaglinide, >=98% (HPLC), solid

Repaglinide, European Pharmacopoeia (EP) Reference Standard

Repaglinide, United States Pharmacopeia (USP) Reference Standard

Repaglinidum

Repaglinidum [INN-Latin]

RTC-063882

s1426

SAM001246546

SBI-0206942.P001

SC-17344

SCHEMBL16137

SMP-508

SMR000466305

SPBio_002906

ST24036034

STK629501

Surepost

Surepost (TN)

TC-063882

Tox21_110721

UNII-668Z8C33LU

W-5210

Z1777729210

ZINC3798537

US Patents and Regulatory Information for PRANDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997	AB	RX	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997	AB	RX	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997	AB	RX	Yes	Yes

Expired US Patents for PRANDIN

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

Paragraph IV (Patent) Challenges for PRANDIN

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	0.5 mg, 1 mg and 2 mg		2005-02-10