Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

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 twenty 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. Three 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:15
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 A-S Medication Solutions 50090-4374 50090-4374-0 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4374-0)
DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287 NDA Cardinal Health 55154-5154 55154-5154-8 1800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55154-5154-8)
Paragraph IV (Patent) Challenges for 022287
Tradename Dosage Ingredient NDA Submissiondate
DEXILANT CAPSULE, DELAYED RELEASE;ORAL dexlansoprazole 022287 2010-11-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength30MG
Approval Date:Jan 30, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 8, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Dec 15, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jul 30, 2023Product 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   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009   Start Trial   Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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