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Last Updated: December 22, 2024

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 four suppliers. There are twelve 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. Nine 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:10
Pharmacology for NDA: 022287
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 022287
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:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength30MG
Approval Date:Jan 30, 2009TE:ABRLD:Yes
Patent:7,790,755*PEDPatent Expiration:Feb 2, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:8,105,626*PEDPatent Expiration:Mar 27, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:8,173,158*PEDPatent Expiration:Sep 17, 2030Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022287

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 9,145,389 ⤷  Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 5,433,959*PED ⤷  Subscribe
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 6,664,276*PED ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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