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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201277

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NDA 201277 describes GADAVIST, 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 GADAVIST profile page.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadobutrol profile page.
Summary for 201277
Tradename:GADAVIST
Applicant:Bayer Hlthcare
Ingredient:gadobutrol
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 201277
Generic Entry Date for 201277*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 201277
Suppliers and Packaging for NDA: 201277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-325 50419-325-11 2 CARTON in 1 BOX (50419-325-11) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 7.5 mL in 1 VIAL, SINGLE-DOSE
GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-325 50419-325-12 2 CARTON in 1 BOX (50419-325-12) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength4.5354GM/7.5ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength6.0472GM/10ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 27, 2019
Regulatory Exclusivity Use:FOR USE IN MAGNETIC RESONANCE ANGIOGRAPHY IN ADULT AND PEDIATRIC PATIENTS (INCLUDING TERM NEONATES) TO EVALUATE KNOWN OR SUSPECTED SUPRA-AORTIC OR RENAL ARTERY DISEASE

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength9.0708GM/15ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes

Expired US Patents for NDA 201277

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-001 Mar 14, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-004 Mar 14, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-003 Mar 14, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-002 Mar 14, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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