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Lomitapide mesylate - Generic Drug Details

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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 Amryt and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lomitapide mesylate has ninety-two patent family members in thirty-seven countries.

There are two drug master file entries for lomitapide mesylate.

Summary for lomitapide mesylate

International Patents:	92
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Bulk Api Vendors:	37
Patent Applications:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lomitapide mesylate
DailyMed Link:	lomitapide mesylate at DailyMed

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
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No			Y	Y
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012		RX	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No			Y	Y

Expired US Patents for lomitapide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012

International Patents for lomitapide mesylate

Country	Patent Number	Estimated Expiration
Austria	283851
Hungary	9300627
Australia	3406493
Croatia	P20130115
Israel	110803
Norway	943260
Australia	4763196

Supplementary Protection Certificates for lomitapide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	2014C/002	Belgium		PRODUCT NAME: LOMITAPIDE ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE TELLE QUE PROTEGEE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/851/001 20130805
1725234	CA 2014 00002	Denmark		PRODUCT NAME: LOMITAPID OG ENHVER TERAPEUTISK AEKVIVALENT FORM DERAF, SOM BESKYTTET I GRUNDPATENTET; REG. NO/DATE: EU/1/13/851/001-003 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	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
1725234	92349	Luxembourg		PRODUCT NAME: LOMITAPIDE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130805
1725234	122014000003	Germany		PRODUCT NAME: LOMITAPID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER DAS PIPERIDIN-N-OXID DAVON; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731