Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Fuji
Johnson and Johnson
Harvard Business School
Argus Health
US Army
Dow
US Department of Justice

Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204781

« Back to Dashboard

NDA 204781 describes DOTAREM, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the DOTAREM profile page.

The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for 204781
Tradename:DOTAREM
Applicant:Guerbet
Ingredient:gadoterate meglumine
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204781
Generic Entry Date for 204781*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
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: 204781
Suppliers and Packaging for NDA: 204781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781 NDA Guerbet LLC 67684-2000 67684-2000-4 6 VIAL in 1 PACKAGE (67684-2000-4) > 100 mL in 1 VIAL
DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781 NDA Guerbet LLC 67684-2000 67684-2000-0 10 VIAL in 1 PACKAGE (67684-2000-0) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength37.69GM/100ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 20, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength3.769GM/10ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 20, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
Medtronic
Julphar
Baxter
Express Scripts
Colorcon
Merck
Cipla

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.