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Serving leading biopharmaceutical companies globally:

Julphar
Fuji
Deloitte
Merck
Queensland Health
Express Scripts
Citi
McKesson
Accenture
Novartis

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022090

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NDA 022090 describes EOVIST, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the EOVIST profile page.

The generic ingredient in EOVIST is gadoxetate disodium. One supplier is listed for this compound. Additional details are available on the gadoxetate disodium profile page.

Summary for NDA: 022090

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022090

Suppliers and Packaging for NDA: 022090

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EOVIST
gadoxetate disodium
SOLUTION;INTRAVENOUS 022090 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-320 50419-320-05 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) > 10 mL in 1 VIAL, SINGLE-DOSE
EOVIST
gadoxetate disodium
SOLUTION;INTRAVENOUS 022090 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-320 50419-320-15 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) > 15 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1.8143GM/10ML (181.43MG/ML)
Approval Date:Jul 3, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 27, 2018
Regulatory Exclusivity Use:ADDITION OF CLINICAL FINDINGS FROM AN OBSERVATIONAL STUDY IN A PEDIATRIC AGE GROUP GREATER THAN 2 MONTHS TO 18 YEARS IN SECTION 8.4 PEDIATRIC USE OF THE PACKAGE INSERT
Patent:► SubscribePatent Expiration:Nov 13, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:MAGNETIC RESONANCE IMAGING OF THE LIVER

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength2.72145GM/15ML (181.43MG/ML)
Approval Date:Feb 4, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 27, 2018
Regulatory Exclusivity Use:ADDITION OF CLINICAL FINDINGS FROM AN OBSERVATIONAL STUDY IN A PEDIATRIC AGE GROUP GREATER THAN 2 MONTHS TO 18 YEARS IN SECTION 8.4 PEDIATRIC USE OF THE PACKAGE INSERT

Expired Orange Book Patents for NDA: 022090

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
EOVIST
gadoxetate disodium
SOLUTION;INTRAVENOUS022090-001Jul 3, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Accenture
Moodys
AstraZeneca
Julphar
Johnson and Johnson
Citi
Queensland Health
QuintilesIMS
Deloitte
Chubb

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