Details for New Drug Application (NDA): 207071

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NDA 207071 describes FINACEA, which is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from four suppliers. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FINACEA profile page.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

Summary for 207071

Tradename:	FINACEA
Applicant:	Leo Pharma As
Ingredient:	azelaic acid
Patents:	8
Formulation / Manufacturing:	see details

Pharmacology for NDA: 207071

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 207071

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071	NDA	LEO Pharma Inc.	50222-303	50222-303-50	1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN
FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071	NDA	LEO Pharma Inc.	50222-303	50222-303-91	1 CAN in 1 CARTON (50222-303-91) > 15 g in 1 CAN

Paragraph IV (Patent) Challenges for 207071

Tradename	Dosage	Ingredient	NDA	Submissiondate
FINACEA	AEROSOL, FOAM;TOPICAL	azelaic acid	207071	2017-09-14

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	15%
Approval Date:	Jul 29, 2015	TE:		RLD:	Yes
Patent:	Start Trial	Patent Expiration:	Oct 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
Patent:	Start Trial	Patent Expiration:	Oct 24, 2023	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	Sep 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 207071

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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