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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 022161


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NDA 022161 describes LEXISCAN, which is a drug marketed by Astellas and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LEXISCAN profile page.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.
Summary for 022161
Tradename:LEXISCAN
Applicant:Astellas
Ingredient:regadenoson
Patents:2
Pharmacology for NDA: 022161
Mechanism of ActionAdenosine Receptor Agonists
Suppliers and Packaging for NDA: 022161
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161 NDA Astellas Pharma US, Inc. 0469-6501 0469-6501-89 5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)
LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1448 51662-1448-1 1 SYRINGE, PLASTIC in 1 CARTON (51662-1448-1) / 5 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.4MG/5ML (0.08MG/ML)
Approval Date:Apr 10, 2008TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 2, 2027Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Feb 2, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022161

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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