Lomitapide mesylate - Generic Drug Details

What are the generic sources for lomitapide mesylate and what is the scope of patent protection?

Lomitapide mesylate is the generic ingredient in one branded drug marketed by Chiesi and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lomitapide mesylate has twenty-seven patent family members in eighteen countries.

There are two drug master file entries for lomitapide mesylate. Three suppliers are listed for this compound.

Summary for lomitapide mesylate

International Patents:	27
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	54
Patent Applications:	385
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lomitapide mesylate
What excipients (inactive ingredients) are in lomitapide mesylate?	lomitapide mesylate excipients list
DailyMed Link:	lomitapide mesylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lomitapide mesylate

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for lomitapide mesylate

Drug Class	Microsomal Triglyceride Transfer Protein Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Microsomal Triglyceride Transfer Protein Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lomitapide mesylate

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for lomitapide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012		RX	Yes	No
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No

Expired US Patents for lomitapide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015

International Patents for lomitapide mesylate

Country	Patent Number	Title	Estimated Expiration
Netherlands	300634
Japan	2014208683	高脂血症および高コレステロール血症に関連する障害または疾患を、副作用を最小限にしつつ処置するための方法 (METHOD FOR TREATMENT OF DISORDER OR DISEASE ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA, WHILE MINIMIZING ADVERSE EFFECT)
Spain	2399721
South Korea	20130004942	METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS
World Intellectual Property Organization (WIPO)	2005087234

Supplementary Protection Certificates for lomitapide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	PA2014001,C1725234	Lithuania		PRODUCT NAME: LOMITAPIDAS; REGISTRATION NO/DATE: EU/1/13/851/001, 2013-07-31 EU/1/13/851/002, 2013-07-31 EU/1/13/851/003 20130731
1725234	CR 2014 00002	Denmark		PRODUCT NAME: LOMITAPID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER PIPERIDIN N-OXIDET DERAF, HERUNDER LOMITAPIDMESYLAT; REG. NO/DATE: EU/1/13/851/001-003 20130805
1725234	206 5001-2014	Slovakia		PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805
1725234	2013/063	Ireland		PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234	300634	Netherlands		PRODUCT NAME: LOMITAPIDE OF HET PIPERIDINE N-OXIDE DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130805