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Last Updated: September 22, 2021

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Details for New Drug Application (NDA): 200063


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NDA 200063 describes CONTRAVE, which is a drug marketed by Nalpropion and is included in one NDA. It is available from three suppliers. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CONTRAVE profile page.

The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.
Summary for 200063
Tradename:CONTRAVE
Applicant:Nalpropion
Ingredient:bupropion hydrochloride; naltrexone hydrochloride
Patents:14
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 200063
Generic Entry Date for 200063*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*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.

Suppliers and Packaging for NDA: 200063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063 NDA PD-Rx Pharmaceuticals, Inc. 43063-772 43063-772-70 70 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-772-70)
CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063 NDA A-S Medication Solutions 50090-2945 50090-2945-0 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2945-0)
Paragraph IV (Patent) Challenges for 200063
Tradename Dosage Ingredient NDA Submissiondate
CONTRAVE TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride; naltrexone hydrochloride 200063 2015-03-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG;8MG
Approval Date:Sep 10, 2014TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Jul 2, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Patent:⤷  Free Forever TrialPatent Expiration:Nov 8, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
Patent:⤷  Free Forever TrialPatent Expiration:Jul 2, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Harvard Business School
Colorcon
Medtronic
McKesson

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 verification 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.