Details for New Drug Application (NDA): 204516

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NDA 204516 describes BRISDELLE, which is a drug marketed by Legacy Pharma and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BRISDELLE profile page.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

Summary for 204516

Tradename:	BRISDELLE
Applicant:	Legacy Pharma
Ingredient:	paroxetine mesylate
Patents:	4

Pharmacology for NDA: 204516

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 204516

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0279	0574-0279-30	30 CAPSULE in 1 BOTTLE (0574-0279-30)
BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516	NDA	Legacy Pharma USA, Inc.	83107-027	83107-027-30	30 CAPSULE in 1 BLISTER PACK (83107-027-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Jun 28, 2013	TE:	AB	RLD:	Yes
Patent:	7,598,271	Patent Expiration:	May 4, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	8,658,663	Patent Expiration:	Apr 6, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Patent:	8,946,251	Patent Expiration:	Aug 4, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 204516

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	5,874,447	⤷ Get Started Free
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	7,598,271	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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