Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Dow
Boehringer Ingelheim
Moodys
Baxter

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

DEXLANSOPRAZOLE - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Dexlansoprazole is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and Par Pharm Inc, and is included in three NDAs. There are twenty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has two hundred and fifty-four patent family members in forty-one countries.

There are seventeen drug master file entries for dexlansoprazole. Three suppliers are listed for this compound.

Recent Clinical Trials for DEXLANSOPRAZOLE

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

SponsorPhase
Taipei Veterans General Hospital, TaiwanN/A
Washington University School of MedicineEarly Phase 1
Northwestern UniversityEarly Phase 1

See all DEXLANSOPRAZOLE clinical trials

Recent Litigation for DEXLANSOPRAZOLE

Identify potential future generic entrants

District Court Litigation
Case NameDate
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. ZYDUS PHARMACEUTICALS (USA) INC.2018-02-12
Takeda Pharmaceutical Company Limited v. Teva Pharmaceuticals USA, Inc.2016-04-08
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. AUROBINDO PHARMA LTD.2015-10-21

See all DEXLANSOPRAZOLE litigation

Pharmacology for DEXLANSOPRAZOLE
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for DEXLANSOPRAZOLE
Synonyms for DEXLANSOPRAZOLE
(+)-(R)-Lansoprazole
(+)-2-((R)-{(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl}sulfinyl)-1H-benzimidazole
(+)-lansoprazol
(r)-(+)-lansoprazole
(R)-(+)2-([3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl)-1H-benzimidazole
(R)-2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole
(R)-Lansoprazole
138530-94-6
1H-Benzimidazole, 2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-
2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole
2-[(R)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole
2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1H-benzimidazole
2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl]-1H-1,3-benzodiazole
AB01563023_01
AB01563023_02
AC-26449
AK170558
AKOS025290765
AN-31849
AS-18086
CCG-213301
CHEBI:135931
CHEMBL1201863
CS-2820
D08903
DB05351
dexilant
Dexilant Solutab
Dexlansoprazole (INN/USAN)
Dexlansoprazole [USAN:INN]
FT-0670721
GTPL5487
HMS3652C14
HY-13662B
Kapidex
KS-00000PLS
MJIHNNLFOKEZEW-RUZDIDTESA-N
MolPort-002-885-834
PB33188
Q-1374
R-(+)-LANSOPRAZOLE
s4099
SC-71768
SCHEMBL44975
SW219466-1
T 168390
T-168390
TAK 390
TAK-390
TAK-390MR
UNII-0K5C5T2QPG component MJIHNNLFOKEZEW-RUZDIDTESA-N
UNII-UYE4T5I70X
UYE4T5I70X
W0028
ZINC599734
Paragraph IV (Patent) Challenges for DEXLANSOPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
DEXILANT CAPSULE, DELAYED RELEASE;ORAL dexlansoprazole 022287 2010-11-30

US Patents and Regulatory Information for DEXLANSOPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 RX Yes No   Start Trial   Start Trial Y Y   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 DEXLANSOPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DEXLANSOPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 2014C/017 Belgium   Start Trial PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023
1129088 PA2014014 Lithuania   Start Trial PRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
1129088 C 2014 021 Romania   Start Trial PRODUCT NAME: DEXLANSOPRAZOL(R)-2-([3-METIL-4-(2,2,2-TRIFLUOROETOXI)PIRIDIN-2-IL]METILSULFINIL)-1H-BENZIMIDAZOL; NATIONAL AUTHORISATION NUMBER: RO6090/2014/01, RO6090/2014/02; DATE OF NATIONAL AUTHORISATION: 20140120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SE 47911; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1129088 1490004-7 Sweden   Start Trial PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
1129088 2014/008 Ireland   Start Trial 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
1129088 C01129088/01 Switzerland   Start Trial PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088 122014000036 Germany   Start Trial PRODUCT NAME: KRISTALLINE FORM DES (R)-2-(((3-METHYL-4-(2,2,2-TRIFLUORETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAOLS; NAT. REGISTRATION NO/DATE: 87192.00.00 87193.00.00 87194.00.00 87195.00.00 20131118 FIRST REGISTRATION: SCHWEDEN 47911 47912 47913 47914 20130919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Express Scripts
McKinsey
Mallinckrodt
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.