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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 022287

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NDA 022287 describes DEXILANT, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from three suppliers. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DEXILANT profile page.

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

Summary for 022287

Tradename:	DEXILANT
Applicant:	Takeda Pharms Usa
Ingredient:	dexlansoprazole
Patents:	8

Pharmacology for NDA: 022287

Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for 022287

Anti-Ulcer Agents
Proton Pump Inhibitors

Suppliers and Packaging for NDA: 022287

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287	NDA AUTHORIZED GENERIC	TWI PHARMACEUTICALS, INC.	24979-703	24979-703-06	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-703-06)
DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287	NDA AUTHORIZED GENERIC	TWI PHARMACEUTICALS, INC.	24979-704	24979-704-06	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-704-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	30MG
Approval Date:	Jan 30, 2009	TE:	AB	RLD:	Yes
Patent:	7,790,755*PED	Patent Expiration:	Feb 2, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,105,626*PED	Patent Expiration:	Mar 27, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,173,158*PED	Patent Expiration:	Sep 17, 2030	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022287

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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	7,285,668*PED	⤷ Get Started Free
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	5,045,321*PED	⤷ Get Started Free
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	8,722,084*PED	⤷ Get Started Free
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	6,939,971*PED	⤷ Get Started Free
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	8,784,885*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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