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Last Updated: March 28, 2024

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 six 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:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022580
Generic Entry Date for 022580*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
Dosage:
CAPSULE, 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: 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 LLC 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 LLC 62541-201 62541-201-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (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
Regulatory Exclusivity Expiration:Jun 24, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:May 15, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jun 14, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY

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

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