DEXILANT Drug Patent Profile

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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-eight patent family members in thirty-four countries.

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

DrugPatentWatch^® 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:	168
US Patents:	11
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	31
Patent Applications:	677
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
What excipients (inactive ingredients) are in DEXILANT?	DEXILANT excipients list
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
University of Karachi	Phase 1
SAMI Pharmaceutical, Karachi Pakistan	Phase 1
Taipei Veterans General Hospital, Taiwan	N/A

See all DEXILANT clinical trials

Pharmacology for DEXILANT

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DEXILANT

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DEXILANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEXILANT	Delayed-release Capsules	dexlansoprazole	30 mg	022287	1	2010-11-30

US Patents and Regulatory Information for DEXILANT

DEXILANT is protected by eight US patents.

Patents protecting 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	022287-001	Jan 30, 2009		RX	Yes	No

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

International Patents for DEXILANT

See the table below for patents covering DEXILANT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011500595
Hong Kong	1038227
Japan	5756548

Supplementary Protection Certificates for DEXILANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1129088	2014/008	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
1129088	1490004-7	Sweden		PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
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