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JUXTAPID Drug Patent Profile

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

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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 7, 2025. This may change due to patent challenges or generic licensing.

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

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

NDA:

203858

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

Sponsor	Phase
Aegerion Pharmaceuticals, Inc.
Amryt Pharma
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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No

Expired US Patents for JUXTAPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012

International Patents for JUXTAPID

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

Country	Patent Number	Title	Estimated Expiration
Australia	699865
China	1106003
Cyprus	1114218

Supplementary Protection Certificates for JUXTAPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	1490006-2	Sweden		PRODUCT NAME: LOMITAPID OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/851/001 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	C 2014 003	Romania		PRODUCT NAME: LOMITAPIDA SAU O SARE ACCEPTABILA FARMACEUTIC SAU PIPERIDIN-N-OXIDUL ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/851/001-003; DATE OF NATIONAL AUTHORISATION: 20130731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/851/001-003; DATE OF FIRST AUTHORISATION IN EEA: 20130731

JUXTAPID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Juxtapid (Lomitapide)

Introduction

Juxtapid, or lomitapide, is a groundbreaking drug approved by the FDA in 2012 for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare and severe genetic disorder characterized by extremely high levels of LDL cholesterol. Here, we delve into the market dynamics and financial trajectory of this critical medication.

Approval and Initial Market Entry

Juxtapid was the first drug to be approved specifically for HoFH, marking a significant milestone in the treatment of this debilitating condition. The drug works by inhibiting the microsomal triglyceride transfer protein (MTP), thereby reducing the production of very-low-density lipoprotein (VLDL) and subsequently lowering LDL cholesterol levels[1][3].

Patient Population and Market Size

The patient population for HoFH is extremely small, with approximately 3,000 patients in the US and another 3,000 in the EU. Despite this limited market, the drug's high price point, estimated between $200,000 to $300,000 per patient per year, suggested significant revenue potential[1].

Commercial Launch and Sales Strategy

Aegerion Pharmaceuticals, the initial developer and marketer of Juxtapid, focused its commercial efforts on apheresis treatment centers and lipidologists. The company targeted the roughly 400 prescribing lipidologists in the US and another 500 in the EU. The sales force was initially lean, with more than 15 reps, and was planned to expand in line with revenue projections[1].

Revenue Projections and Performance

Initial revenue forecasts were promising, with peak sales potential estimated at $240 million in the US and $180 million in the EU. However, the actual performance did not meet these expectations. The drug faced significant competition from emerging therapies, particularly the PCSK9 inhibitors, which impacted its sales trajectory[1][4].

Competitive Landscape

The HoFH treatment market became increasingly competitive with the emergence of new therapies. Sanofi and Isis Pharmaceuticals' Kynamro (mipomersen) and the PCSK9 inhibitors, such as Amgen's AMG-145, posed significant challenges to Juxtapid's market share. These new drugs offered alternative treatment options for patients with high LDL cholesterol, further complicating Juxtapid's commercial success[1].

Regulatory and Market Withdrawal

Despite its initial approval in the EU under the name Lojuxta, Juxtapid faced significant challenges in gaining strong sales traction. In 2016, Aegerion announced the withdrawal of Juxtapid from the EU market due to limited success in obtaining pricing and reimbursement approvals. The drug remained available in the US, Brazil, and potentially Japan, subject to approval[4].

Financial Impact and Restructuring

The withdrawal from the EU market and the competitive pressures led to a significant restructuring effort by Aegerion. The company reduced its workforce by 13% and aimed to cut operating expenses by $25 million to $35 million in 2017. These measures were part of a broader cost reduction program to extend the company's cash position and facilitate cash generation from operations[4].

Current Financial Status Under Amryt Pharmaceuticals

In 2016, Aegerion merged with QLT to form Novelion Therapeutics, which later merged with Amryt Pharmaceuticals. Under Amryt, the financial performance of Juxtapid has been part of the company's broader portfolio. In Q2 2022, Amryt reported a $6.9 million operating loss before finance expenses for Juxtapid, highlighting the ongoing challenges in maintaining profitability for this drug[5].

Key Financial Highlights

• Revenue Growth: Despite the challenges, Amryt reported overall revenue growth, but Juxtapid's performance has been mixed. The drug contributed to the company's operating loss, although non-cash adjustments and restructuring costs played a significant role[5].
• Cash Position: As of June 30, 2022, Amryt had a cash position of $90.7 million, indicating the company's efforts to manage its financial resources amidst the competitive landscape[5].

Strategic Considerations

Aegerion's decision to withdraw Juxtapid from the EU and focus on other markets was a strategic move to realign resources and optimize financial performance. The company's intention to evaluate strategic options, including divestiture or licensing of Juxtapid, reflects the ongoing challenges in maintaining a viable market presence for this drug[4].

Expert Insights and Market Analysis

Industry analysts have noted the significant impact of competitive therapies on Juxtapid's sales. For instance, Jefferies analyst Eun Yang highlighted the potential for PCSK9 inhibitors to be used in combination with Juxtapid, which could augment LDL-C reduction but also further complicate the market dynamics[1].

Conclusion

Juxtapid, despite its groundbreaking approval for treating HoFH, has faced numerous challenges in the market. From regulatory hurdles and competitive pressures to financial restructuring and market withdrawal, the drug's trajectory has been complex. Here are the key takeaways:

Key Takeaways

• Market Approval: Juxtapid was the first drug approved specifically for HoFH.
• Patient Population: The drug targets a very small patient population globally.
• Pricing and Revenue: High price point but lower-than-expected revenue due to competition.
• Competitive Landscape: Significant competition from PCSK9 inhibitors and other therapies.
• Regulatory Challenges: Withdrawn from the EU market due to reimbursement issues.
• Financial Performance: Mixed results under Amryt Pharmaceuticals, with ongoing operating losses.
• Strategic Considerations: Realignment of resources and evaluation of strategic options.

FAQs

Q: What is Juxtapid used for? A: Juxtapid is used to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder characterized by extremely high levels of LDL cholesterol.

Q: Who developed Juxtapid? A: Juxtapid was developed by Aegerion Pharmaceuticals, which later merged with other companies to form Novelion Therapeutics and eventually Amryt Pharmaceuticals.

Q: Why was Juxtapid withdrawn from the EU market? A: Juxtapid was withdrawn from the EU market due to limited success in obtaining pricing and reimbursement approvals.

Q: How does Juxtapid work? A: Juxtapid works by inhibiting the microsomal triglyceride transfer protein (MTP), reducing the production of VLDL and subsequently lowering LDL cholesterol levels.

Q: What are the financial challenges faced by Juxtapid? A: Juxtapid has faced significant financial challenges, including lower-than-expected revenue, operating losses, and the need for restructuring and cost reduction programs.

Sources

1. MMM-Online: Drug for ultrarare lipid disorder OK'd by FDA.
2. GlobeNewswire: Amryt Reports Record Q2 2022 Results.
3. Minnesota Department of Human Services: Juxtapid.
4. FierceBiotech: More woe for Aegerion as ax swings again; withdraws Juxtapid from EU.
5. Investis: Amryt Reports Record Q2 2022 Results.