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DEXILANT Drug Profile

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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 twenty-one patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-eight patent family members in thirty-three 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.

Summary for DEXILANT

International Patents:	188
US Patents:	15
Applicants:	1
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	40
Clinical Trials:	16
Patent Applications:	103
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXILANT
DailyMed Link:	DEXILANT at DailyMed

Pharmacology for DEXILANT

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for DEXILANT

Anti-Ulcer Agents

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)PYRIDIN-2-YL)METHYLSULFINYL)-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]methanesulfinyl]-1H-1,3-benzodiazole

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

3B1-001176

AB01563023_01

AB01563023_02

AC-26449

AK170558

AKOS025290765

AN-31849

AS-18086

CCG-213301

CHEBI:135931

CHEMBL1201863

CS-2820

D06YYD

D08903

DB05351

Dexilant Solutab

dexlansoprazole

Dexlansoprazole (INN/USAN)

Dexlansoprazole [USAN:INN]

Dexlansoprazole sesquihydrate

FT-0670721

GTPL5487

HE065042

HMS3652C14

HY-13662B

Kapidex

KS-00000PLS

KS-1075

MFCD13196699

MJIHNNLFOKEZEW-RUZDIDTESA-N

MolPort-002-885-834

PB33188

Q-1374

R- -Lansoprazole

R-(+)-LANSOPRAZOLE

r-lansoprazole

s4099

SC-71768

SCHEMBL44975

T 168390

T-168390

TAK 390

TAK-390

TAK-390MR

UNII-0K5C5T2QPG component MJIHNNLFOKEZEW-RUZDIDTESA-N

UNII-UYE4T5I70X

UYE4T5I70X

W0028

ZINC599734

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	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
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No					Y

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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	022287-002	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	022287-002	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009

Paragraph IV (Patent) Challenges for DEXILANT

Drugname	Dosage	Strength	RLD	Submissiondate
	Delayed-release Capsule	30 mg		2010-11-30
	Capsule	60 mg		2010-08-25

Non-Orange Book US Patents for DEXILANT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,737,282	Benzimidazole compound crystal
7,339,064	Benzimidazole compound crystal
8,884,019	Benzimidazole compound crystal
9,889,152	Multiple PPI dosage form

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International Patents for DEXILANT

Country	Document Number	Estimated Expiration
Slovenia	1129088
Japan	5756548
Argentina	103296
New Zealand	515702

Supplementary Protection Certificates for DEXILANT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2014014,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
90004-7	Sweden		PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
2014014	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