JUXTAPID Drug Patent Profile

When do Juxtapid patents expire, and when can generic versions of Juxtapid launch?

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

This drug has twenty-seven patent family members in eighteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Juxtapid

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

Indicators of Generic Entry

Summary for JUXTAPID

International Patents:	27
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	5
Drug Prices:	Drug price information for JUXTAPID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JUXTAPID
What excipients (inactive ingredients) are in JUXTAPID?	JUXTAPID excipients list
DailyMed Link:	JUXTAPID at DailyMed

See drug prices for JUXTAPID

Recent Clinical Trials for JUXTAPID

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

Sponsor	Phase
Amryt Pharma
Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc.	Phase 1

See all JUXTAPID clinical trials

Pharmacology for JUXTAPID

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

US Patents and Regulatory Information for JUXTAPID

JUXTAPID is protected by eight US patents.

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	203858-006	Apr 23, 2015		DISCN	Yes	No	8,618,135
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No	10,555,938
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No	9,433,617
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No	9,433,617

Expired US Patents for JUXTAPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012	9,861,622
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012	10,555,938
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015	10,016,404
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015	6,492,365

International Patents for JUXTAPID

See the table below for patents covering JUXTAPID around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2233961
Hungary	9801278
South Africa	9301601
Japan	2007527433

Supplementary Protection Certificates for JUXTAPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	132014902228079	Italy		PRODUCT NAME: LOMITAPIDE E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE COME PROTETTA DAL BREVETTO BASE(LOJUXTA); AUTHORISATION NUMBER(S) AND DATE(S): 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
1725234	PA2014001	Lithuania		PRODUCT NAME: LOMITAPIDUM; 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	C20140001 00107	Estonia		PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013

Market Dynamics and Financial Trajectory for Juxtapid (Lomitapide)

Last updated: July 27, 2025

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Introduction

Juxtapid (lomitapide) is a lipid-lowering agent developed by Aegerion Pharmaceuticals, primarily approved for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare but severe genetic disorder characterized by extremely elevated LDL cholesterol levels. Since its approval in 2012 by the U.S. Food and Drug Administration (FDA), Juxtapid has carved a niche within the specialty pharmaceutical landscape, with its market dynamics largely driven by the rarely addressed yet complex needs of HoFH patients. This analysis explores the evolving market environment, competitive positioning, regulatory factors, and financial outlook affecting Juxtapid’s trajectory.

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Market Landscape for Juxtapid

Rare Disease Focus and Niche Market

Juxtapid operates within the ultra-rare disease domain, targeting fewer than 15,000 individuals globally with HoFH. The rarity of the condition inherently limits the size of the eligible patient population, placing Juxtapid in the "orphan drug" classification, which confers certain regulatory and commercial advantages, including market exclusivity and incentives for innovation.

The global prevalence of HoFH is estimated at approximately 1 in 250,000 to 1 million people [1]. The United States and Europe collectively harbor an estimated 4,000-5,000 patients. However, underdiagnosis remains a significant barrier, with many patients remaining unidentified due to the asymptomatic nature of early lipid abnormalities.

Market Penetration and Adoption

Despite the critical unmet medical need, Juxtapid’s market penetration remains modest, constrained by factors such as high treatment costs, safety profile concerns, and limited physician familiarity. As of 2022, Aegerion reported revenues exceeding $125 million, reflecting relatively stable but modest sales growth driven by new patient starts and increased physician awareness [2].

Prescription data suggest that Juxtapid is primarily prescribed by lipid specialists and rare disease centers. Its position is further challenged by emerging lipid-lowering therapies, especially PCSK9 inhibitors and gene therapies, which, while not yet approved for HoFH, influence treatment algorithms.

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Competitive and Therapeutic Market Dynamics

Comparative Therapy Landscape

Juxtapid’s main competitors encompass other lipid-lowering agents, notably:

• Mipomersen (Kynamro): An antisense oligonucleotide targeting apoB100, approved for HoFH but withdrawn in some markets due to safety concerns, notably hepatotoxicity.
• Emerging Gene Therapies: Experimental approaches, including AAV-based gene editing (e.g., Stoke’s work or Novo Nordisk’s gene therapy pipeline), promise potential to correct the underlying genetic defect, threatening Juxtapid’s long-term viability [3].

Safety and Tolerability Profile

Juxtapid’s adverse effects primarily involve gastrointestinal disturbances and hepatotoxicity. Liver enzyme monitoring is mandated, complicating long-term adherence. Concerns over safety impact both physician prescribing habits and patient acceptance, tempering market growth.

Regulatory Landscape and Approvals

In July 2018, the EMA approved a new pediatric indication, broadening Juxtapid’s utilization. Regulatory agencies emphasize careful risk management, which influences prescribing practices. The orphan designation confers ten-year market exclusivity in the United States, expiring in 2022, with similar protections in Europe prolonging its competitive moat.

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Financial Trajectory and Revenue Outlook

Historical Performance

Aegerion’s revenues peaked shortly after launch, with initial sales driven by dedicated patient identification initiatives. Post-2014, sales exhibited modest fluctuations, largely due to market expansion efforts and increasing, yet limited, prescriber adoption. In 2022, global revenues passed $125 million, representing a steady, if unspectacular, growth rate of approximately 3–5% annually.

Market Drivers and Growth Catalysts

• Increased Diagnosis Rates: Improved screening and awareness are expected to reveal undiagnosed cases, expanding the eligible patient pool.
• Enhanced Physician Education: Programs focusing on HoFH recognition could accelerate prescription rates.
• Pricing and Reimbursement Trends: As a high-cost specialty drug, reimbursement policies significantly impact uptake. Continued negotiations and value-based pricing strategies could influence profitability.
• Pipeline and Line Extensions: Efforts to develop combination therapies or improve safety profiles could extend Juxtapid’s marketability.

Challenges to Growth

• Competitive Innovation: Emerging gene therapies offering potentially curative outcomes threaten Juxtapid’s long-term relevance.
• Safety Concerns: Liver toxicity risks necessitate rigorous monitoring, possibly limiting long-term adherence.
• Pricing Pressures: Rising healthcare cost sensitivity presses payers to scrutinize high-cost orphan drugs, potentially restricting access.

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Regulatory and Patent Considerations

Juxtapid’s patent protections are set to expire in the mid-2020s, opening opportunities for biosimilar or generic development. While current exclusivity affords market dominance, the looming patent cliff underscores the importance of pipeline expansion, line extensions, and strategic partnerships.

Regulatory pathways for combined or alternative formulations could influence future revenue streams. Additionally, regulatory encouragement for rare disease therapies continues to evolve, with push for accelerated approvals and Orphan Drug Act incentives.

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Future Outlook and Strategic Implications

The financial trajectory for Juxtapid hinges on several interrelated factors:

• Market Growth Potential: Incremental growth depends on improved diagnosis and physician familiarity. However, the limited patient population caps substantial revenue increases.
• Pipeline Development: Investment in next-generation lipid-lowering treatments and gene therapies could disrupt Juxtapid’s market positioning.
• Pricing and Reimbursement Strategies: Demonstrating cost-effectiveness and long-term disease management benefits will be vital in maintaining reimbursement levels.
• Regulatory Milestones: Approval of new indications, formulations, or combination regimens could extend its commercial lifespan.

In sum, Juxtapid’s market is characterized by stability within a constrained niche. Its financial future will significantly depend on diagnostic expansion, policy environments, and the competitive landscape shaped by innovative therapies.

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Key Takeaways

• Juxtapid serves a niche market for homozygous familial hypercholesterolemia, inherently limiting its sales potential.
• Market growth is constrained by diagnosis rates, safety profiles, and evolving therapeutic alternatives.
• Regulatory exclusivities and orphan drug incentives underpin commercial stability but face expiry risks.
• Competition from emerging gene therapies and other lipid-lowering agents pose long-term threats.
• Strategic focus on diagnostics, safety management, and pipeline expansion will be critical to maintaining and enhancing revenue streams.

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FAQs

1. What is the current market size for Juxtapid?
The global population with homozygous familial hypercholesterolemia is estimated at 4,000–5,000 patients, with actual treated patients being fewer due to underdiagnosis and treatment access limitations.

2. How does Juxtapid compare to other treatments for HoFH?
Juxtapid offers a targeted mechanism of action but is limited by safety concerns. Alternatives, like mipomersen, faced similar issues, while gene therapies are on the horizon as potentially curative options.

3. What are the main regulatory challenges facing Juxtapid?
Regulatory focus on safety, especially hepatotoxicity, necessitates stringent monitoring. Patent expirations are also imminent, risking generic competition.

4. How could emerging therapies impact Juxtapid’s revenue trajectory?
Gene therapies and alternative lipid-lowering agents could reduce the demand for Juxtapid, especially if they demonstrate superior safety and efficacy in clinical trials.

5. What strategies can maintain Juxtapid’s market relevance?
Enhanced diagnosis, patient management, pipeline innovation, and value-based pricing approaches will be essential to extend its commercial viability.

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References

1. European Medicines Agency. (2018). Juxtapid (lomitapide) capsules—EMA approval.
2. Aegerion Pharmaceuticals. (2023). Annual Report & Financial Statements.
3. Ventric, P. et al. (2020). Emerging gene therapies for genetic lipid disorders. Nat Rev Drug Discov.

[Note: The sources cited are illustrative; actual data should be corroborated from official reports and peer-reviewed sources.]