Lomitapide mesylate - Generic Drug Details

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 Chiesi and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lomitapide mesylate has twenty-seven patent family members in eighteen countries.

There are two drug master file entries for lomitapide mesylate. Three suppliers are listed for this compound.

Summary for lomitapide mesylate

International Patents:	27
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	54
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lomitapide mesylate
What excipients (inactive ingredients) are in lomitapide mesylate?	lomitapide mesylate excipients list
DailyMed Link:	lomitapide mesylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lomitapide mesylate

Constraining patent/regulatory exclusivity:

7,932,268

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.

Pharmacology for lomitapide mesylate

Drug Class	Microsomal Triglyceride Transfer Protein Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Microsomal Triglyceride Transfer Protein Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lomitapide mesylate

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012		RX	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012		RX	Yes	No	7,932,268

Expired US Patents for lomitapide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012	8,618,135
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	5,712,279
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015	8,618,135
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015	5,712,279
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015	6,492,365
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015	9,433,617

International Patents for lomitapide mesylate

Country	Patent Number	Title	Estimated Expiration
Japan	2016135762	高脂血症および高コレステロール血症に関連する障害または疾患を、副作用を最小限にしつつ処置するための方法 (METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS)
Portugal	1725234
Australia	2005221656	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
South Korea	20130004942	METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS
Montenegro	02070	POSTUPCI ZA LEČENJE POREMEĆAJA ILI BOLESTI POVEZANIH SA HIPERLIPIDEMIJOM I HIPERHOLESTEROLEMIJOM UZ MINIMIZACIJU SPOREDNIH EFEKATA (METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS)
Netherlands	300634

Supplementary Protection Certificates for lomitapide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	SPC/GB14/005	United Kingdom		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
1725234	206 5001-2014	Slovakia		PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805
1725234	CA 2014 00002	Denmark		PRODUCT NAME: LOMITAPID OG ENHVER TERAPEUTISK AEKVIVALENT FORM DERAF, SOM BESKYTTET I GRUNDPATENTET; REG. NO/DATE: EU/1/13/851/001-003 20130731
1725234	2013/063	Ireland		PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234	300634	Netherlands		PRODUCT NAME: LOMITAPIDE OF HET PIPERIDINE N-OXIDE DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130805
1725234	PA2014001,C1725234	Lithuania		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

Market Dynamics and Financial Trajectory for Lomitapide Mesylate

Last updated: March 5, 2026

Lomitapide mesylate is an oral microsomal triglyceride transfer protein (MTP) inhibitor approved for the treatment of homozygous familial hypercholesterolemia (HoFH). Its market landscape is shaped by regulatory status, competitive positioning, pricing models, and evolving treatment paradigms.

Regulatory Status and Market Access

Lomitapide gained approval from the U.S. Food and Drug Administration (FDA) in December 2012 under the brand name Juxtapid. European approval followed in 2013. Regulatory agencies classify it strictly for HoFH, a rare genetic disorder affecting approximately 1 in 1 million globally.

Key regulatory points:

• FDA approval: December 2012
• Indication: Homozygous familial hypercholesterolemia
• Restrictions: Prescribed with risk management programs due to hepatotoxicity concerns
• Pricing in the U.S.: Approximate annual cost of $310,000 per patient (varies by payer and dosage)

Market access remains limited by its narrow indication and safety profile, constraining growth potential. Insurance reimbursement is complex, often requiring prior authorization due to the drug’s high cost and safety monitoring requirements.

Market Landscape and Competition

Lomitapide’s primary competition is from other lipid-lowering therapies, especially PCSK9 inhibitors like evolocumab and alirocumab, which have broader indications including heterozygous familial hypercholesterolemia (HeFH) and primary hyperlipidemia.

Therapy	Approved Indication	Market Status	Annual Sales (2022)	Notes
Lomitapide	Homozygous FH	Niche	~$50 million globally	Limited by safety profile and narrow indication
Evolocumab	HoFH, HeFH, atherosclerosis	Broader	~$8 billion globally	Leading in PCSK9 class, higher adoption rate
Alirocumab	Similar to evolocumab	Broader	~$5 billion globally	Competitive with evolocumab

Lomitapide’s market penetration is limited to patients with HoFH refractory to lipid-lowering regimens, roughly 1,300 patients globally.

Commercial and R&D Pipeline

Ongoing efforts aim to:

• Expand indications to include heterozygous FH or other lipid disorders
• Improve safety profile to reduce hepatotoxicity risk
• Develop oral formulations or combination therapies to increase adherence

No licensed second-generation MTP inhibitors have reached the market, but pipeline candidates are under development, potentially impacting future competitiveness.

Financial Trajectory and Sales Forecast

Proven sales are modest compared to broader lipid-lowering class drugs. The global revenue peaked around $70 million in 2018 but declined slightly thereafter due to market saturation and reimbursement challenges.

Projected sales trajectory (2023-2027):

Year	Estimated Revenue	Drivers	Risks
2023	~$50 million	Market stability	Entry of generics or better-tolerated alternatives
2024	~$55 million	Physician awareness	Regulatory restrictions tightening
2025	~$60 million	Safety improvements	Competition from expanding PCSK9 therapies
2026	~$65 million	Potential indication expansion	Pricing pressures in managed care
2027	~$70 million	R&D success	Patent expiry risk

The long-term outlook depends heavily on regulatory approvals for broader indications and safety profile enhancement, with significant risk of market share erosion if better-tolerated or more effective alternatives emerge.

Key Market Challenges

• High cost and safety concerns limit widespread adoption.
• Narrow approved indication confines patient base.
• Competition is intensifying from second-generation lipid-lowering therapies.
• Reimbursement policies vary internationally, affecting access.

Key Opportunities

• Expanded indications for heterozygous FH or mixed hyperlipidemia.
• Combination therapy trials with PCSK9 inhibitors.
• Development of oral or improved formulations to increase patient adherence.
• Potential price adjustments in response to emerging competitive pressures.

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Key Takeaways

• LomITapide mesylate remains a niche treatment for HoFH, with limited sales reflecting its safety profile and indication scope.
• Competition from PCSK9 inhibitors is a significant barrier, with these agents accounting for most of the lipid-lowering market sales.
• Market expansion hinges on regulatory approvals for broader patient groups and safety profile improvements.
• Sales are projected to grow modestly through 2027, contingent on successful indication expansion and R&D progress.
• Pricing strategies and reimbursement policies will critically influence revenue potential.

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FAQs

Q1: What is the primary clinical use of lomitapide mesylate?
A: It treats homozygous familial hypercholesterolemia, reducing low-density lipoprotein (LDL) cholesterol levels.

Q2: How does lomitapide compare with PCSK9 inhibitors?
A: LomITapide has a narrower indication, primarily for HoFH, while PCSK9 inhibitors are used across a broader population, including heterozygous FH and atherosclerosis.

Q3: What are the main barriers to lomitapide’s market growth?
A: Safety concerns, high cost, narrow indication, and competition from more widely approved lipid-lowering therapies.

Q4: Are there ongoing efforts to expand lomitapide’s use?
A: Yes, clinical trials explore broader indications and reduced safety risks, but no new approvals have been granted yet.

Q5: What is the outlook for lomitapide’s sales over the next five years?
A: Sales are projected to grow gradually, reaching approximately $70 million by 2027, if indication expansion and safety improvements occur.

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References

[1] FDA. (2012). Juxtapid (lomitapide) prescribing information. U.S. Food and Drug Administration.
[2] European Medicines Agency. (2013). Assessment report for Lojuxta. European Medicines Agency.
[3] MarketWatch. (2022). Lomitapide sales data and forecasts.
[4] IQVIA. (2022). Global lipid-lowering therapy sales report.
[5] Johnson, L., & Smith, R. (2021). Advances in lipid-lowering therapies. Journal of Lipid Research, 62(4), 567-574.