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Lansoprazole - Generic Drug Details

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

Lansoprazole is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Krka Tovarna Zdravil, Labs Liconsa, Lannett Co Inc, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Zydus Hlthcare, Takeda Pharms Usa, Glaxosmithkline Cons, Takeda Pharms Na, Ani Pharms Inc, Dexcel Pharma, and Teva Pharms Usa, and is included in twenty-nine NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fifty-six drug master file entries for lansoprazole. Eighty-three suppliers are listed for this compound.

Summary for lansoprazole

US Patents:	6
Tradenames:	7
Applicants:	21
NDAs:	29
Drug Master File Entries:	56
Suppliers / Packagers:	83
Bulk Api Vendors:	95
Clinical Trials:	127
Patent Applications:	6,777
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for lansoprazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lansoprazole
DailyMed Link:	lansoprazole at DailyMed

Pharmacology for lansoprazole

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors
Physiological Effect	Inhibition Gastric Acid Secretion

Medical Subject Heading (MeSH) Categories for lansoprazole

Anti-Ulcer Agents

Proton Pump Inhibitors

Synonyms for lansoprazole

(+)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole

103577-45-3

1H-Benzimidazole, 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-

1H-Benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-

2-?[[[3-?METHYL-?4-?(2,?2,?2-?TRIFLUOROETHOXY)-?2-?PYRIDINYL]METHYL]SULFINYL]-?1H-?BENZIMIDAZOLE

2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole

2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)-1H-benzimidazole

2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)benzimidazole

2-(((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole

2-({[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl}sulfinyl)benzimidazol e

2-({[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl)-1H-1,3-benzodiazole

2-({[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl)-1H-benzimidazole

2-({3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl} sulphinylbenzimidazole;2-({3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl} sulphinylbenzimidazole

2-[({3-methyl-4-[(2,2,2-trifluoroethyl)oxy]pyridin-2-yl}methyl)sulfinyl]-1H-benzimidazole

2-[[ [3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluoro-ethoxy)-2-pyridinyl]methyl]-sulfinyl]1H-benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl]sulfinyl]benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole

2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole

2-[[[3-methyl-4-(2,2,2-trifluroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole

2-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylsulfinyl]-1H-benzimidazole

2-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1H-benzimidazole

2-[[3-methyl-4-(2,2,2-trifluoroethoxy)pyrid-2-yl]methylsulfinyl]benzimidazole

2-[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1H-benzimidazole

2-[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1H-benzoimidazole

2-[[3-methyl-4-[2,2,2-tris(fluoranyl)ethoxy]pyridin-2-yl]methylsulfinyl]-1H-benzimidazole

2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-1H-benzimidazole

2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-1H-benzoimidazole

2-[3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-benzimidazole

2-[3-methyl-4-(2,2,2-trifluoro-ethoxy)pyridin-2-ylmethanesulfinyl]-benzimidazole

2-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl-methanesulfinyl]-1H-benzimidazole

2-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-ylmethanesulfinyl]-1H-benzimidazole

2-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanesulfinyl}-1H-1,3-benzodiazole

2-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl}-1H-benzimidazole

577L453

A 65006

A-65006

A800764

AB0005100

AB00052388

AB00052388_18

AB00052388_19

AB00052388-17

AB2000063

Abbot Brand of Lansoprazole

ABT-006

AC1L1GX8

ACT03358

AG 1749

AG-1749

Agopton

Agopton (TN)

AKOS005554811

Almirall Brand of Lansoprazole

AN-15125

API0005388

Aprazol

Bamalite

BBL029072

BC208317

BDBM47032

BDBM50070208

BG0232

BIDD:GT0006

Bio-0824

Biuret Gr

Biuret Reagent Solution

Blason

BPBio1_001194

BRD-A49172652-001-05-7

BRN 4333393

BSPBio_001084

BSPBio_001830

C-21097

C16H14F3N3O2S

CAS-103577-45-3

CC-29843

CCG-39952

CG-4801

CHEBI:6375

CHEMBL480

cid_3883

CL0035

Compraz

CPD000058469

CS-1847

CTK8F0500

D00355

D0M4HV

Dakar

DB00448

DivK1c_000920

DR002018

DSSTox_CID_3200

DSSTox_GSID_23200

DSSTox_RID_76922

DTXSID4023200

EBD14854

EU-0100709

F2173-0222

FT-0082011

FT-0610894

GP5308

GTPL7208

HE130807

HE291353

HMS1571G06

HMS1922M04

HMS2052F05

HMS2093M07

HMS2098G06

HMS2234B10

HMS3262M19

HMS3264E12

HMS3269D15

HMS3371E21

HMS3394F05

HMS3654J17

HMS502N22

Hoechst Brand of Lansoprazole

Hormona Brand of Lansoprazole

HSDB 7204

HY-13662

I06-0018

IDI1_000920

Ilsatec

J-007154

KBio1_000920

KBio2_002060

KBio2_004628

KBio2_007196

KBio3_001330

KBioGR_001491

KBioSS_002060

Ketian

KS-00000VHO

L 8533

L0233

Lancid

Lanfast

Lanproton

LANSAPRAZOLE

Lansopep

Lansophed

Lansoprazol

Lansoprazol [INN-Spanish]

Lansoprazole (JAN/USP/INN)

Lansoprazole (JP17/USP/INN)

Lansoprazole [USAN:BAN:INN]

Lansoprazole for peak identification, European Pharmacopoeia (EP) Reference Standard

Lansoprazole, >=98% (TLC), powder

Lansoprazole, 98% 500mg

Lansoprazole, British Pharmacopoeia (BP) Reference Standard

Lansoprazole, European Pharmacopoeia (EP) Reference Standard

Lansoprazole, United States Pharmacopeia (USP) Reference Standard

Lansoprazole.

Lansoprazolum

Lansoprazolum [INN-Latin]

Lansox

Lansox (TN)

Lanston

Lanz

Lanzo

Lanzol

Lanzol-30

Lanzopral

lanzoprazole

Lanzor

Lanzul

Lapraz

Lasoprol

Lederle Brand of Lansoprazole

Limpidex

Lopac-L-8533

Lopac0_000709

LP00709

LS-33080

MCULE-8446262134

Mesactol

MFCD00866873

MJIHNNLFOKEZEW-UHFFFAOYSA-N

MLS-0003247.0001

MLS000069705

MLS000759405

MLS001074170

MLS001424235

MolPort-003-666-508

Monolitum

NC00411

NCGC00015615-01

NCGC00015615-02

NCGC00015615-03

NCGC00015615-04

NCGC00015615-05

NCGC00015615-06

NCGC00015615-07

NCGC00015615-08

NCGC00015615-09

NCGC00015615-10

NCGC00015615-11

NCGC00015615-12

NCGC00015615-14

NCGC00015615-15

NCGC00023826-03

NCGC00023826-04

NCGC00023826-05

NCGC00023826-06

NCGC00023826-07

NCGC00254925-01

NCGC00261394-01

NINDS_000920

NSC-758638

NSC-758710

NSC758638

NSC758710

Ogast

Ogast (TN)

Ogastro

Opera_ID_1676

Opiren

Pharmakon1600-01503926

Pharmakon1600-01504282

Prestwick0_001072

Prestwick1_001072

Prestwick2_001072

Prestwick3_001072

Prevacid

Prevacid (TN)

Prevacid 24HR

Prevacid Delayed Release

Prevacid I.V

Prevacid I.V.

Prevacid Iv

Prevacid NapraPAC

Prevacid SoluTab

Prevacid, Prevacid NapraPAC, Prevacid SoluTab, Lansoprazole

Prevacid;Prevacid NapraPAC;Prevacid SoluTab

PrevOnco

Prezal

Pro Ulco

Promeco

Promeco Brand of Lansoprazole

Promp

Prosogan

PubChem16834

RT-013461

s1354

Salvar Brand of Lansoprazole

SAM001246544

SBI-0050687.P003

SC-15158

SCHEMBL22365

SMR000058469

SPBio_000488

SPBio_002992

Spectrum_001580

SPECTRUM1503926

Spectrum2_000444

Spectrum3_000295

Spectrum4_000856

Spectrum5_001521

ST51015040

STK621169

Suprecid

TAK 390MR

TAK390MR

Takeda Brand of Lansoprazole

Takepron

Takepron (TN)

TAP Brand of Lansoprazole

Tecnobio Brand of Lansoprazole

TL8000155

Tox21_110184

Tox21_110184_1

Tox21_301023

Tox21_500709

Ulpax

Vinas Brand of Lansoprazole

Wyeth Brand of Lansoprazole

Zoprol

Zoton

US Patents and Regulatory Information for lansoprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Hlthcare	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	202366-002	Aug 19, 2013	AB	RX	No	No
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	AB	RX	Yes	Yes					Y
Glaxosmithkline Cons	PREVACID 24 HR	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	022327-001	May 18, 2009		OTC	Yes	Yes
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003		DISCN	No	No
Teva Pharms	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	077255-002	Nov 10, 2009	AB	RX	No	No
Perrigo R And D	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	202319-001	May 18, 2012		OTC	No	No
Labs Liconsa	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	203203-002	Jul 25, 2016	AB	RX	No	No

Expired US Patents for lansoprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002

International Patents for lansoprazole

Country	Document Number	Estimated Expiration
Portugal	1561458
Portugal	1736144
Hong Kong	1077742
China	1310613
Cyprus	1110988
World Intellectual Property Organization (WIPO)	9959544
China	1149077

Supplementary Protection Certificates for lansoprazole

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
14/008	Ireland		PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209