Last Updated: November 8, 2026

Leo Pharm Company Profile

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What is the competitive landscape for LEO PHARM

LEO PHARM has thirteen approved drugs.

There are thirteen US patents protecting LEO PHARM drugs.

Summary for Leo Pharm

US Patents:	13
Tradenames:	9
Ingredients:	8
NDAs:	13
Patent Litigation for Leo Pharm:	See patent lawsuits for Leo Pharm

Drugs and US Patents for Leo Pharm

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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	GEL;TOPICAL	021470-001	Dec 24, 2002	AB	RX	Yes	Yes		⤷ Start Trial				⤷ Start Trial
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,617,698	⤷ Start Trial	Y			⤷ Start Trial
Leo Pharma As	ANZUPGO	delgocitinib	CREAM;TOPICAL	219155-001	Jul 23, 2025		RX	Yes	Yes		⤷ Start Trial				⤷ Start Trial
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993	AB	RX	Yes	No		⤷ Start Trial				⤷ Start Trial
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,716,799	⤷ Start Trial	Y			⤷ Start Trial
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,265,725	⤷ Start Trial	Y			⤷ Start Trial
>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 Leo Pharm

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	RE39706	⤷ Start Trial
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	6,753,013	⤷ Start Trial
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	8,435,498	⤷ Start Trial
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000	5,665,727	⤷ Start Trial
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	4,866,048	⤷ Start Trial
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006	5,763,426	⤷ Start Trial
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	5,763,426	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for LEO PHARM drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Gel	15%	➤ Subscribe	2012-07-27
➤ Subscribe	Gel	0.05%	➤ Subscribe	2010-12-01
➤ Subscribe	Ointment	0.03%	➤ Subscribe	2010-11-22
➤ Subscribe	Topical Solution	0.01%	➤ Subscribe	2006-05-19
➤ Subscribe	Topical Foam	15%	➤ Subscribe	2017-09-14
➤ Subscribe	Ointment	0.1%	➤ Subscribe	2010-09-09
➤ Subscribe	Ointment	0.005%/0.064%	➤ Subscribe	2010-03-31

International Patents for Leo Pharm Drugs

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Country	Patent Number	Estimated Expiration
Australia	2010278066	⤷ Start Trial
China	1856294	⤷ Start Trial
South Korea	101749514	⤷ Start Trial
Israel	173092	⤷ Start Trial
Brazil	PI0612429	⤷ Start Trial
Australia	2009211147	⤷ Start Trial
South Africa	200507019	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Leo Pharm Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	202140009	Slovenia	⤷ Start Trial	PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435024	2190014-7	Sweden	⤷ Start Trial	PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2460806	2590009-3	Sweden	⤷ Start Trial	PRODUCT NAME: DELGOCITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE THEREOF; REG. NO/DATE: EU/1/24/1851 20240923
2460806	202540009	Slovenia	⤷ Start Trial	PRODUCT NAME: DELGOCITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A SOLVATE THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/24/1851/001-002; DATE OF NATIONAL AUTHORISATION: 20240919; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435024	301102	Netherlands	⤷ Start Trial	PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2460806	301321	Netherlands	⤷ Start Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), DEMERGER
2460806	C02460806/01	Switzerland	⤷ Start Trial	PRODUCT NAME: DELGOCITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69330 13.11.2024
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.