Viewing data from:

JUXTAPID

NDA

LOMITAPIDE MESYLATE | N203858 | CHIESI FARMACEUTICI SPA

7 strengths2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivityIPRPTAB Challenge

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Today

7932268

Aug. 19, 2027IPR

12472172

Jul. 29, 2041

NPP

Feb. 25, 2029

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2015-01836	7932268	IPR	Coalition for Affordable Drugs VIII	Final Written Decision	2015-08-28	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects NCT02080468	Phase 1	Completed	Aegerion Pharmaceuticals, Inc.	32	2014-02-19 → 2014-04-24

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$38581.58

Highest Price

$39431.80

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
10122-0405-28JUXTAPID 5MG CAP	$38581.58	FSS	Chiesi USA, Inc.	09/30/2026
10122-0410-28JUXTAPID 10MG CAP	$38719.60	FSS	Chiesi USA, Inc.	09/30/2026
10122-0420-28JUXTAPID 20MG CAP	$39431.80	FSS	Chiesi USA, Inc.	09/30/2026
10122-0430-28JUXTAPID 30MG CAP	$39091.05	FSS	Chiesi USA, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Juxtapid (2024)

Total Spending

$7.0M

Total Claims

117

Beneficiaries

Avg Cost/Unit

$1968.68

Spending Trend

$9.9M(2019)→$10.8M(2020)→$9.4M(2021)→$8.5M(2022)→$8.7M(2023)→$7.0M(2024)

YoY Change:+2.8%

5yr CAGR:+4.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALIVUS LIFE SCIENCES LTDLOMITAPIDE MESYLATE

DMF 302722016

MAITHRI DRUGS PRIVATE LTDLOMITAPIDE MESYLATE (FORM-M)

DMF 314542017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Feb 27, 2026	SUPPL -27	View Letter (PDF)
Jun 17, 2022	SUPPL -24	View Letter (PDF)
Feb 2, 2022	SUPPL -23	View Letter (PDF)
May 28, 2021	SUPPL -22	View Letter (PDF)
Dec 26, 2019	SUPPL -19	View Letter (PDF)
Jun 5, 2018	SUPPL -18	View Letter (PDF)
Aug 4, 2017	SUPPL -17	View Letter (PDF)
Jan 5, 2017	SUPPL -13	View Letter (PDF)
Jan 5, 2017	SUPPL -16	View Letter (PDF)
May 25, 2016	SUPPL -15	View Letter (PDF)
Mar 10, 2016	SUPPL -12	View Letter (PDF)
Apr 24, 2015	SUPPL -10	View Letter (PDF)
Aug 11, 2014	SUPPL -9	View Letter (PDF)
Feb 19, 2014	SUPPL -6	View Letter (PDF)
Aug 15, 2013	SUPPL -1	View Letter (PDF)
Apr 16, 2013	SUPPL -2	View Letter (PDF)
Dec 27, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — EQ 5MG BASE

RLD

2 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Dec 21, 2012

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7932268	Aug 19, 2027	—	—	—		—
12472172	Jul 29, 2041	—	—	—		—

Exclusivities (1)

Code	Date	Status
NPP	Feb 25, 2029	Active

#002 — EQ 10MG BASE

RLD

2 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Dec 21, 2012

#003 — EQ 20MG BASE

RLD

2 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Dec 21, 2012

#004 — EQ 30MG BASE

RLD

2 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Apr 23, 2015

#005 — EQ 40MG BASE

RLD

1 patent1 exclusivity▾

CAPSULE;ORAL | Approved: Apr 23, 2015

#006 — EQ 60MG BASE

RLD

1 patent0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 23, 2015

#007 — EQ 2MG BASE

RLD

2 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Feb 25, 2026