Leo Pharm Company Profile

What is the competitive landscape for LEO PHARM, and when can generic versions of LEO PHARM drugs launch?

LEO PHARM has twelve approved drugs.

There are thirteen US patents protecting LEO PHARM drugs.

There are one hundred and sixty-five patent family members on LEO PHARM drugs in twenty-six countries and eight supplementary protection certificates in seven countries.

Summary for Leo Pharm

International Patents:	165
US Patents:	13
Tradenames:	8
Ingredients:	7
NDAs:	12
Drug Master File Entries:	2
Patent Litigation for Leo Pharm:	See patent lawsuits for Leo Pharm

Drugs and US Patents for Leo Pharm

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	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006	AB	RX	Yes	Yes
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	8,435,498
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,211,259
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	10,617,698		Y
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	AB	RX	Yes	Yes
Leo Pharm	PINDAC	pinacidil	CAPSULE, EXTENDED RELEASE;ORAL	019456-001	Dec 28, 1989		DISCN	No	No

Expired US Patents for Leo Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006	5,763,426
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	6,753,013
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	6,753,013
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	6,787,529
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	8,435,498
Leo Pharma As	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006	6,387,383

Paragraph IV (Patent) Challenges for LEO PHARM drugs

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

International Patents for Leo Pharm Drugs

Country	Patent Number	Estimated Expiration
Israel	222865
Israel	198688
Canada	2565754
European Patent Office	1919448
European Patent Office	2494959
Ukraine	109785

Supplementary Protection Certificates for Leo Pharm Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2190014-7	Sweden		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
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024	301102	Netherlands		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
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Leo Labs
• Leo Pharm
• Leo Pharma As