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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022580

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NDA 022580 describes QSYMIA, which is a drug marketed by Vivus and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QSYMIA profile page.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for NDA: 022580

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:11
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022580

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL 022580 NDA Vivus, Inc. 62541-201 62541-201-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14)
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL 022580 NDA Vivus, Inc. 62541-201 62541-201-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 3.75MG BASE;23MG
Approval Date:Jul 17, 2012TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 23, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
Patent:► SubscribePatent Expiration:Jun 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
Patent:► SubscribePatent Expiration:Jun 14, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT

Expired Orange Book Patents for NDA: 022580

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-002Jul 17, 2012► Subscribe► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-001Jul 17, 2012► Subscribe► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-003Jul 17, 2012► Subscribe► Subscribe
Vivus
QSYMIA
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-004Jul 17, 2012► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fuji
US Department of Justice
Moodys
Accenture
Covington
Merck
McKinsey
Harvard Business School
Novartis
Chinese Patent Office

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.

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