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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 lomitapide mesylate patent protection?

Lomitapide mesylate is the generic ingredient in one branded drug marketed by Aegerion 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 ninety-one patent family members in thirty-six countries.

There are two drug master file entries for lomitapide mesylate. One supplier is listed for this compound.

Summary for lomitapide mesylate

International Patents:	91
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	19
Clinical Trials:	534
Patent Applications:	4
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lomitapide mesylate
DailyMed Link:	lomitapide mesylate at DailyMed

Pharmacology for lomitapide mesylate

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

Synonyms for lomitapide mesylate

1-(4-{9-[(2,2,2-trifluoroethyl)carbamoyl]-9H-fluoren-9-yl}butyl)-4-({[4'-(trifluoromethyl)biphenyl-2-yl]carbonyl}amino)piperidinium methanesulfonate

202914-84-9

2522AH

9H-Fluorene-9-carboxamide, N-(2,2,2-trifluoroethyl)-9-(4-(4-(((4'-(trifluoromethyl)(1,1'-biphenyl)-2-yl)carbonyl)amino)-1-piperidinyl)butyl)-, methanesulfonate

AEGR-733 mesylate;BMS-201038 mesylate;AEGR733 mesylate;BMS201038 mesylate;AEGR 733 mesylate;BMS 201038 mesylate

AKOS025149431

BMS 201038-04

BMS-201038-04

C39H37F6N3O2.CH4O3S

CHEBI:72299

CHEMBL2105662

CS-3424

D09638

DTXSID60174170

EX-A502

FT-0700260

HY-14668

J-690260

Juxtapid (TN)

KB-75599

Lojuxta (TN)

Lomitapide (mesylate)

Lomitapide mesilate (JAN)

Lomitapide mesylate (USAN)

Lomitapide mesylate [USAN]

lomitapide methanesulfonate

lomitapide monomesylate

MFCD19443682

MolPort-035-789-730

N-(2,2,2-trifluoroethyl)-9-[4-(4-{2-[4-(trifluoromethyl)phenyl]benzamido}piperidin-1-yl)butyl]-9H-fluorene-9-carboxamide; methanesulfonic acid

N-(2,2,2-trifluoroethyl)-9-{4-(4-({(4'-(trifluoromethyl)biphenyl-2-yl)carbonyl}amino)piperidin-1-yl)butyl}-9H-fluorene-9-carboxamide methanesulfonate

N-(2,2,2-trifluoroethyl)-9-{4-[4-({[4'-(trifluoromethyl)biphenyl-2-yl]carbonyl}amino)piperidin-1-yl]butyl}-9H-fluorene-9-carboxamide methanesulfonate

QC-11679

QKVKOFVWUHNEBX-UHFFFAOYSA-N

s7633

SCHEMBL2731380

UNII-X4S83CP54E

X4S83CP54E

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
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		RX	Yes	Yes
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		RX	Yes	Yes
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		RX	Yes	Yes			Y	Y
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No

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Expired US Patents for lomitapide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012
Aegerion	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012

Non-Orange Book US Patents for lomitapide mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,789,197	Microsomal triglyceride transfer protein
5,595,872	Nucleic acids encoding microsomal trigyceride transfer protein
6,066,650	Inhibitors of microsomal triglyceride transfer protein and method
6,034,098	Inhibitors of microsomal triglyceride transfer protein and method

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International Patents for lomitapide mesylate

Country	Document Number	Estimated Expiration
Israel	110803
Hungary	9402542
Denmark	1725234
Hungary	T67962

Supplementary Protection Certificates for lomitapide mesylate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014000003	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
2014001	Lithuania		PRODUCT NAME: LOMITAPIDUM; 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
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
6 5001-2014	Slovakia		PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805