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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206406


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NDA 206406 describes ENVARSUS XR, which is a drug marketed by Veloxis Pharms Inc and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the ENVARSUS XR profile page.

The generic ingredient in ENVARSUS XR is tacrolimus. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 206406
Tradename:ENVARSUS XR
Applicant:Veloxis Pharms Inc
Ingredient:tacrolimus
Patents:16
Formulation / Manufacturing:see details
Pharmacology for NDA: 206406
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 206406
Suppliers and Packaging for NDA: 206406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406 NDA Veloxis Pharmaceuticals, Inc 68992-3010 68992-3010-1 1 POUCH in 1 CARTON (68992-3010-1) > 1 BOTTLE in 1 POUCH > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406 NDA Veloxis Pharmaceuticals, Inc 68992-3010 68992-3010-3 1 POUCH in 1 CARTON (68992-3010-3) > 1 BOTTLE, PLASTIC in 1 POUCH > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 0.75MG BASE
Approval Date:Jul 10, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 10, 2022
Regulatory Exclusivity Use:PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY TRANSPLANT PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Patent:  Start TrialPatent Expiration:May 30, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 30, 2024Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Express Scripts
Mallinckrodt

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