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Last Updated: June 13, 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:⤷  Sign UpPatent Expiration:Feb 2, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent 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 022287-002 Jan 30, 2009 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.