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

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204096

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NDA 204096 describes ASTAGRAF XL, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASTAGRAF XL profile page.

The generic ingredient in ASTAGRAF XL is tacrolimus. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 204096
Tradename:ASTAGRAF XL
Applicant:Astellas
Ingredient:tacrolimus
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 204096
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 204096
Suppliers and Packaging for NDA: 204096
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096 NDA Astellas Pharma US, Inc. 0469-0647 0469-0647-73 1 BOTTLE in 1 CARTON (0469-0647-73) > 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE
ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096 NDA Astellas Pharma US, Inc. 0469-0677 0469-0677-73 1 BOTTLE in 1 CARTON (0469-0677-73) > 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 204096
Tradename Dosage Ingredient NDA Submissiondate
ASTAGRAF XL CAPSULE, EXTENDED RELEASE;ORAL tacrolimus 204096 2013-09-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 0.5MG BASE
Approval Date:Jul 19, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 25, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 25, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ONCE A DAY ADMINISTRATION
Patent:  Start TrialPatent Expiration:Mar 25, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ONCE A DAY ADMINISTRATION

Expired US Patents for NDA 204096

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013   Start Trial   Start Trial
>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 verifification 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.