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Last Updated: January 23, 2020

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JUXTAPID Drug Profile

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Which patents cover Juxtapid, and what generic alternatives are available?

Juxtapid is a drug marketed by Aegerion and is included in one NDA. There are nine patents protecting this drug.

This drug has ninety-two patent family members in thirty-seven countries.

The generic ingredient in JUXTAPID is lomitapide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lomitapide mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Juxtapid

Juxtapid was eligible for patent challenges on December 21, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 21, 2020. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for JUXTAPID
Drug Prices for JUXTAPID

See drug prices for JUXTAPID

Generic Entry Opportunity Date for JUXTAPID
Generic Entry Date for JUXTAPID*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for JUXTAPID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aegerion Pharmaceuticals, Inc.N/A
Aegerion Pharmaceuticals, Inc.Phase 1

See all JUXTAPID clinical trials

Recent Litigation for JUXTAPID

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 JUXTAPID litigation

Synonyms for JUXTAPID
182431-12-5
202833-31-6
210823-48-6
431T125
82KUB0583F
9-(4-{4-[(4'-Trifluoromethyl-biphenyl-2-carbonyl)-amino]-piperidin-1-yl}-butyl)-9H-fluorene-9-carboxylic acid (2,2,2-trifluoro-ethyl)-amide
9-(4-{4-[(4''-Trifluoromethyl-biphenyl-2-carbonyl)-amino]-piperidin-1-yl}-butyl)-9H-fluorene-9-carboxylic acid (2,2,2-trifluoro-ethyl)-amide
9-(4-{4-[(4''''-Trifluoromethyl-biphenyl-2-carbonyl)-amino]-piperidin-1-yl}-butyl)-9H-fluorene-9-carboxylic acid (2,2,2-trifluoro-ethyl)-amide
9H-Fluorene-9-carboxamide, N-(2,2,2-trifluoroethyl)-9-(4-(4-(((4'-(trifluoromethyl)(1,1'-biphenyl)-2-yl)carbonyl)amino)-1-piperidinyl)butyl)-
AEGR 733
AEGR 773
AEGR-733
AEGR-733(Lomitapide)
AEGR-733Lomitapide
AEGR-773
AEGR-773, BMS-201038
AEGR733
AEGR773
AKOS025149590
AN-30534
AOB2202
BCP06821
BDBM50098320
BMS 201038
BMS 201038-01
BMS 201238
BMS-201038
BMS-201038-01
BMS201038
C39H37F6N3O2
CHEBI:72297
CHEMBL354541
CS-3423
D09637
DB08827
DTXSID50171294
FT-0750236
GTPL7439
HMS3653B17
HSDB 8218
HY-14667
J-690250
KB-74526
L0298
Lojuxta
lomitapida
Lomitapide
Lomitapide (USAN/INN)
Lomitapide [USAN:INN]
Lomitapide, >=98% (HPLC)
lomitapidum
MBBCVAKAJPKAKM-UHFFFAOYSA-N
MolPort-028-754-209
N-(2,2,2-trifluoroethyl)-9-(4-(4-(4'-(trifluoroMet
n-(2,2,2-trifluoroethyl)-9-(4-(4-(4'-(trifluoromethyl)biphenyl-2-ylcarboxamido)piperidin-1-yl)butyl)-9h-fluorene-9-carboxamide
N-(2,2,2-trifluoroethyl)-9-[4-(4-{2-[4-(trifluoromethyl)phenyl]benzamido}piperidin-1-yl)butyl]-9H-fluorene-9-carboxamide
N-(2,2,2-trifluoroethyl)-9-[4-[4-[[2-[4-(trifluoromethyl)phenyl]benzoyl]amino]-1-piperidyl]butyl]fluorene-9-carboxamide
N-(2,2,2-trifluoroethyl)-9-[4-[4-[[2-[4-(trifluoromethyl)phenyl]benzoyl]amino]piperidin-1-yl]butyl]fluorene-9-carboxamide
N-(2,2,2-Trifluoroethyl)-9-[4-[4-[4'-(trifluoromethyl)-[1,1'-biphenyl]-2-ylcarboxamido]piperidin-1-yl]butyl]-9H-fluorene-9-carboxamide
N-(2,2,2-trifluoroethyl)-9-{4-(4-({(4'-(trifluoromethyl)biphenyl-2- yl)carbonyl}amino)piperidin-1-yl)butyl}-9H-fluorene-9-carboxamide
N-(2,2,2-trifluoroethyl)-9-{4-[4-({[4'-(trifluoromethyl)biphenyl-2-yl]carbonyl}amino)piperidin-1-yl]butyl}-9H-fluorene-9-carboxamide
NCGC00386364-05
s7635
SB16780
SC-14090
SCHEMBL304604
SW220160-1
UNII-82KUB0583F
Z1876
ZINC27990463

US Patents and Regulatory Information for JUXTAPID

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 203858-005 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 203858-005 Apr 23, 2015 RX Yes No   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 203858-005 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 JUXTAPID

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 203858-002 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
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015   Start Trial   Start Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for JUXTAPID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725234 C20140001 00107 Estonia   Start Trial PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013
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 1490006-2 Sweden   Start Trial PRODUCT NAME: LOMITAPID OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/851/001 20130731
1725234 92349 Luxembourg   Start Trial PRODUCT NAME: LOMITAPIDE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130805
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
1725234 SPC/GB14/005 United Kingdom   Start Trial PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR THE PIPERIDINE N-OXIDE THEREOF; REGISTERED: UK EU/1/13/851/001 20130805; UK EU/1/13/851/002 20130805; UK EU/1/13/851/003 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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