FINACEA Drug Patent Profile

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When do Finacea patents expire, and when can generic versions of Finacea launch?

Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-seven patent family members in twenty countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Finacea

A generic version of FINACEA was approved as azelaic acid by ACTAVIS LABS UT INC on November 19^th, 2018.

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Summary for FINACEA

International Patents:	137
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	12
Patent Applications:	3,875
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FINACEA
Drug Sales Revenues:	Drug sales revenues for FINACEA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINACEA
What excipients (inactive ingredients) are in FINACEA?	FINACEA excipients list
DailyMed Link:	FINACEA at DailyMed

Drug patent expirations by year for FINACEA

Recent Clinical Trials for FINACEA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Clinical Research Center of the Carolinas	Phase 4
DPT Laboratories, Ltd.	Phase 3

See all FINACEA clinical trials

Pharmacology for FINACEA

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Paragraph IV (Patent) Challenges for FINACEA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FINACEA	Topical Foam	azelaic acid	15%	207071	1	2017-09-14
FINACEA	Gel	azelaic acid	15%	021470	1	2012-07-27

US Patents and Regulatory Information for FINACEA

FINACEA is protected by five US patents.

Patents protecting FINACEA

Foamable composition combining a polar solvent and a hydrophobic carrier
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Penetrating pharmaceutical foam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Penetrating pharmaceutical foam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Antibiotic kit and composition and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FINACEA

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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	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FINACEA

See the table below for patents covering FINACEA around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038147		⤷ Sign Up
Slovakia	7082000	COMPOSITION WITH AZELAIC ACID	⤷ Sign Up
Japan	2008540509		⤷ Sign Up
Cyprus	1115989		⤷ Sign Up
Japan	S62215522	REMEDY FOR NON ACNE INFLAMMATION,CONTAGIOUS SKIN DISEASE ANDALOPECIA	⤷ Sign Up
New Zealand	540166	Cosmetic and pharmaceutical foam	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration