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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 Aegerion 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. One supplier is listed for this compound.

Summary for lomitapide mesylate

International Patents:	92
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	32
Patent Applications:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lomitapide mesylate
DailyMed Link:	lomitapide mesylate at DailyMed

Recent Litigation for lomitapide mesylate

Identify potential future generic entrants

PTAB Litigation

Petitioner	Date
Coalition for Affordable Drugs VIII	2015-08-28
COALITION FOR AFFORDABLE DRUGS VIII, LLC	2015-08-28

See all lomitapide mesylate litigation

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

BCP10696

BMS 201038-01

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

MolPort-035-789-730

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

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

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

Expired US Patents for lomitapide mesylate

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

International Patents for lomitapide mesylate

Country	Patent Number	Estimated Expiration
Japan	2014208683
Japan	2007527433
Germany	69633983
Japan	4298801
Israel	116917
Latvia	11951

Supplementary Protection Certificates for lomitapide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	C20140001 00107	Estonia		PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013
1725234	PA2014001	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
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
1725234	498	Finland
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	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