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Last Updated: December 9, 2019

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Lomitapide mesylate - Generic Drug Details

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What are the generic drug sources for lomitapide mesylate and what is the scope of freedom to operate?

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.

Recent Litigation for lomitapide mesylate

Identify potential future generic entrants

PTAB Litigation
PetitionerDate
Coalition for Affordable Drugs VIII2015-08-28
COALITION FOR AFFORDABLE DRUGS VIII, LLC2015-08-28

See all lomitapide mesylate litigation

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 203858-006 Apr 23, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lomitapide mesylate

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

Supplementary Protection Certificates for lomitapide mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725234 206 5001-2014 Slovakia   Start Trial PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805
1725234 PA2014001,C1725234 Lithuania   Start Trial 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 1490006-2 Sweden   Start Trial PRODUCT NAME: LOMITAPID OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/851/001 20130731
1725234 C300634 Netherlands   Start Trial PRODUCT NAME: LOMITAPIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS DOOR HET BASISOCTROOI BESCHERMD; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234 C20140001 00107 Estonia   Start Trial PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013
1725234 CR 2014 00002 Denmark   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Mallinckrodt
Baxter
Johnson and Johnson
Harvard Business School

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