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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Juxtapid (2023)

Total Spending

$8.7M

Total Claims

139

Beneficiaries

Avg Cost/Unit

$1914.71

Spending Trend

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

YoY Change:+7.2%

5yr CAGR:+6.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7932268	Aug 19, 2027	—	—	—		—
12472172	Jul 29, 2041	—	—	—	U-4438	—

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

Change History (6)

Recent changes detected for this application.

ADDED7/1/2026

Chiesi's New Chemical Entity exclusivity for Juxtapid (lomitapide mesylate) supplement 004 became effective with this Orange Book entry.

New: New record

ADDED7/1/2026

New: New record

ADDED7/1/2026

New: New record

ADDED7/1/2026

Chiesi obtained new drug exclusivity protection for lomitapide mesylate (Juxtapid) under a new supplemental application.

New: New record

ADDED7/1/2026

New: New record

ADDED7/1/2026

Juxtapid (lomitapide mesylate) received New Chemical Entity exclusivity designation under NDA 203858, Supplement 005.

New: New record