Details for New Drug Application (NDA): 022580

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NDA 022580 describes QSYMIA, which is a drug marketed by Vivus Llc and is included in one NDA. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for 022580

Tradename:	QSYMIA
Applicant:	Vivus Llc
Ingredient:	phentermine hydrochloride; topiramate
Patents:	6

Pharmacology for NDA: 022580

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Appetite Suppression Decreased Central Nervous System Disorganized Electrical Activity Increased Sympathetic Activity

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:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 3.75MG BASE;23MG
Approval Date:	Jul 17, 2012	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 13, 2027
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY
Patent:	8,580,298	Patent Expiration:	May 15, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,580,299	Patent Expiration:	Jun 14, 2029	Product 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	6,071,537	⤷ Start Trial
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	7,659,256	⤷ Start Trial
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	7,553,818	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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