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Fuji
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US Army
Baxter
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QuintilesIMS

Generated: April 27, 2018

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 ten 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 022580
Tradename:QSYMIA
Applicant:Vivus
Ingredient:phentermine hydrochloride; topiramate
Patents:10
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 N 62541-201-14
QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580 NDA Vivus, Inc. 62541-201 N 62541-201-30

Profile 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:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent 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
Patent:➤ Try a Free TrialPatent 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

Expired US Patents for NDA 022580

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
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Citi
Federal Trade Commission
Baxter
Teva
US Department of Justice
Merck
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