Mipomersen sodium - Generic Drug Details

What are the generic sources for mipomersen sodium and what is the scope of freedom to operate?

Mipomersen sodium is the generic ingredient in one branded drug marketed by Kastle Theraps Llc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Mipomersen sodium has forty-five patent family members in eleven countries.

Summary for mipomersen sodium

International Patents:	45
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	9
Patent Applications:	1,364
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mipomersen sodium
What excipients (inactive ingredients) are in mipomersen sodium?	mipomersen sodium excipients list
DailyMed Link:	mipomersen sodium at DailyMed

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

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 mipomersen sodium

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

Sponsor	Phase
Kastle Therapeutics, LLC	Phase 1
Ionis Pharmaceuticals, Inc.	Phase 1
Kastle Therapeutics, LLC	Phase 3

See all mipomersen sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for mipomersen sodium

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

US Patents and Regulatory Information for mipomersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013		DISCN	Yes	No				Y

Expired US Patents for mipomersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013

EU/EMA Drug Approvals for mipomersen sodium

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	Kynamro	mipomersen sodium	EMEA/H/C/002429treatment of cholesterol and hypercholesterolaemia	Refused	no	no	no		2013-05-29

International Patents for mipomersen sodium

Country	Patent Number	Title	Estimated Expiration
Portugal	2174945
European Patent Office	2336145	Modulation par anti-sense de l'expression de apolipoprotéine B (Antisense modulation of apolipoprotein B expression)
Slovenia	2336318

Mipomersen sodium Market Analysis and Financial Projection

Last updated: February 14, 2026

What are the current market dynamics for mipomersen sodium?

Mipomersen sodium is an antisense oligonucleotide approved by the FDA in 2013 for homozygous familial hypercholesterolemia (HoFH). Its market is constrained by limited indications, high costs, and the availability of alternative lipid-lowering therapies.

Market Size and Adoption:
In 2022, the global market for mipomersen was valued at approximately $60 million, primarily in the U.S. where it has regulatory approval. Adoption remains limited due to concerns over adverse events, particularly hepatotoxicity, and the availability of more established therapies such as PCSK9 inhibitors.

Competition Landscape:
Mipomersen's primary competitors include PCSK9 inhibitors (alirocumab, evolocumab), lomitapide, and emerging gene-silencing therapies. PCSK9 inhibitors, which demonstrate superior safety profiles and broader approval, have captured a significant share of the lipid-lowering market.

Regulatory Environment:
While FDA approval exists, various regulatory bodies have expressed concerns about safety, limiting mipomersen's use. The European Medicines Agency (EMA) did not approve mipomersen, citing safety issues and limited efficacy data.

Pipeline and Off-Label Use:
Research investigates mipomersen in other lipid disorders and rare genetic conditions, but no significant pipeline developments have translated into approved indications or commercial success. Off-label use remains rare due to safety concerns.

How does the financial trajectory of mipomersen sodium look?

Revenue Trends:
Sales peaked around 2015 at approximately $70 million but declined to $50 million by 2020, with further downward pressure expected owing to the decline in new patient initiation.

Pricing and Reimbursement:
The average annual cost per patient is approximately $150,000, reflecting its high price point relative to other lipid-lowering drugs. Reimbursement is primarily through Medicare and private insurers, although coverage is inconsistent due to safety profiles.

Research and Development Investment:
Pfizer, the manufacturer, allocated minimal R&D funds to mipomersen post-2015, shifting focus toward newer therapeutics. No significant pipeline investments are announced for mipomersen.

Forecasts and Growth Potential:
Projections estimate the market size for mipomersen to decline to $20 million by 2025. Growth potential is limited by safety concerns, lack of broader indications, and competition.

Market Challenges:

• Safety profile issues lead to restricted prescribing.
• The emergence of RNA interference therapies (e.g., inclisiran) offers alternative mechanisms with favorable safety profiles.
• Regulatory restrictions hamper broader adoption outside of specialist centers.

What are the key factors influencing mipomersen sodium's market and financial performance?

Factor	Influence on Market Dynamics	Impact on Financial Trajectory
Safety concerns	Limit prescription, reduce adoption	Decrease revenue, restrict growth
Pricing	High costs limit payer acceptance	Constrain revenues
Competition	PCSK9 inhibitors, lomitapide outperform in safety and efficacy	Reduce market share
Regulatory stance	Restricted approvals and guidance	Curtail market expansion
Unmet medical needs	Limited due to safety profiles	Minor opportunities in niche markets

Key Takeaways

• Mipomersen sodium's market is shrinking due to safety issues and the availability of better-tolerated therapies.
• Revenue declined from a peak of approximately $70 million in 2015 to below $50 million in 2020, with forecasts estimating further decline.
• The therapy faces regulatory and reimbursement barriers that limit its adoption.
• Innovative therapies like RNA interference drugs pose significant competition, reducing mipomersen’s future market potential.
• Limited pipeline activity and safety profile concerns restrict opportunities for market expansion, making mipomersen an increasingly niche product.

FAQs

1. Why has mipomersen sodium experienced declining sales since 2015?
Sales declined due to safety concerns—mainly hepatotoxicity—and competition from PCSK9 inhibitors offering safer profiles.

2. Are there any approved alternative therapies for homozygous familial hypercholesterolemia?
Yes, PCSK9 inhibitors like evolocumab and alirocumab are approved for some HoFH patients, with better safety and efficacy profiles.

3. What regulatory hurdles does mipomersen face?
Regulators have limited approval due to safety concerns, especially hepatotoxicity, constraining its use mainly to specialist settings.

4. Is there potential for mipomersen in other indications?
Current research is limited; no significant new indications are in advanced development, reducing future growth prospects.

5. What is the outlook for mipomersen sodium's financial performance?
Forecasts indicate continued decline, with revenues dropping to around $20 million by 2025 owing to safety issues and competitive pressures.

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Sources:
[1] Pfizer Annual Reports, 2013–2022
[2] FDA Drug Approvals Database
[3] MarketResearch.com, 2023 Industry Data
[4] European Medicines Agency (EMA) Documents
[5] IQVIA Medicine Use and Spending Data, 2022