DrugPatentWatch Database Preview

DEXILANT Drug Profile

Email this page to a colleague

« Back to Dashboard

Which patents cover Dexilant, and what generic alternatives are available?

Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are seventeen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ninety-five patent family members in thirty-five countries.

The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.

US ANDA Litigation and Generic Entry Outlook for Dexilant

A generic version of DEXILANT was approved as dexlansoprazole by PAR PHARM INC on April 19^th, 2017.

Summary for DEXILANT

International Patents:	195
US Patents:	15
Applicants:	1
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	49
Clinical Trials:	17
Patent Applications:	106
Drug Prices:	Drug price information for DEXILANT
Drug Sales Revenues:	Drug sales revenues for DEXILANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXILANT
DailyMed Link:	DEXILANT at DailyMed

See drug prices for DEXILANT

See drug sales revenues for DEXILANT

Recent Clinical Trials for DEXILANT

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

Sponsor	Phase
Taipei Veterans General Hospital, Taiwan	N/A
Ramathibodi Hospital	Phase 4
Hikma Pharma,Egypt	Phase 1

See all DEXILANT clinical trials

Recent Litigation for DEXILANT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Takeda Pharmaceutical Co., Ltd. v. Mylan Inc	2014-01-21
Takeda Pharmaceutical Co v. Impax Laboratories, Inc.	2013-11-19
Takeda Pharmaceutical Co., Ltd. v. Mylan Inc.	2013-08-28

See all DEXILANT litigation

Pharmacology for DEXILANT

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Synonyms for DEXILANT

(+)-(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)-

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

AS-18086

BDBM50247930

CCG-213301

CHEBI:135931

CHEMBL1201863

CS-2820

D08903

DB05351

Dexilant Solutab

dexlansoprazole

Dexlansoprazole (INN/USAN)

Dexlansoprazole [USAN:INN]

FT-0670721

GTPL5487

HMS3652C14

HY-13662B

Kapidex

KS-00000PLS

Lansoprazole r-form

MJIHNNLFOKEZEW-RUZDIDTESA-N

PB33188

Q-1374

Q5268339

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 DEXILANT

Tradename	Dosage	Ingredient	NDA	Submissiondate
DEXILANT	CAPSULE, DELAYED RELEASE;ORAL	dexlansoprazole	022287	2010-11-30

US Patents and Regulatory Information for DEXILANT

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 SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No					Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No			Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No			Y	Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y

Expired US Patents for DEXILANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009

International Patents for DEXILANT

Country	Patent Number	Estimated Expiration
Brazil	PI0011674
Japan	4160293
Slovenia	1553929
Portugal	1337525
Canada	2737851

Supplementary Protection Certificates for DEXILANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1129088	2014C/017	Belgium		PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023
1129088	C01129088/01	Switzerland		PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088	PA2014014,C1129088	Lithuania		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	PA2014014	Lithuania		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		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