Omacetaxine mepesuccinate - Generic Drug Details

What are the generic sources for omacetaxine mepesuccinate and what is the scope of patent protection?

Omacetaxine mepesuccinate is the generic ingredient in one branded drug marketed by Teva Pharms Intl and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omacetaxine mepesuccinate has twenty-one patent family members in twelve countries.

There are two drug master file entries for omacetaxine mepesuccinate.

Summary for omacetaxine mepesuccinate

International Patents:	21
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	16
What excipients (inactive ingredients) are in omacetaxine mepesuccinate?	omacetaxine mepesuccinate excipients list
DailyMed Link:	omacetaxine mepesuccinate at DailyMed

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

Dosage:

POWDER;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 omacetaxine mepesuccinate

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
University of Colorado, Denver	Phase 1/Phase 2
The University of Hong Kong	Phase 2

See all omacetaxine mepesuccinate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for omacetaxine mepesuccinate

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OMACETAXINE MEPESUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNRIBO	for Injection	omacetaxine mepesuccinate	3.5 mg/vial	203585	1	2016-10-26

US Patents and Regulatory Information for omacetaxine mepesuccinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012		DISCN	Yes	No

Expired US Patents for omacetaxine mepesuccinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012

International Patents for omacetaxine mepesuccinate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2177223	Homoharringtonine seule ou en combinaison avec d'autres agents pour une utilisation dans le traitement des leucémies myélogènes chroniques résistantes ou intolérantes aux inhibiteurs de protéine kinase à l'exception du STI 571 (Homoharringtonine alone or combined with other agents for use in treating chronic myelogenous leukemia resistant or intolerant to protein kinase inhibitors other than STI 571)
Portugal	1443933
European Patent Office	1443933	TRAITEMENT DE LA LEUCEMIE MYELOIDE CHRONIQUE, RESISTANTE OU INTOLERANTE AU STI571, IMPLIQUANT L'HOMOHARRINGTONINE SEUL OU EN COMBINAISON AVEC D'AUTRES AGENTS (TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA, RESISTANT OR INTOLERANT TO STI571, INVOLVING HOMOHARRINGTONINE ALONE OR COMBINED WITH OTHER AGENTS)
World Intellectual Property Organization (WIPO)	03020252
Germany	60234708
Austria	451106

Market Dynamics and Financial Trajectory for Omacetaxine Mepesuccinate

Last updated: July 28, 2025

Introduction

Omacetaxine Mepesuccinate, marketed as Synribo, is a targeted therapy approved for the treatment of chronic myeloid leukemia (CML), particularly in patients resistant or intolerant to tyrosine kinase inhibitors (TKIs). As a semi-synthetic cephalotaxin, it represents a distinct class of anti-cancer agents with a mechanism involving direct inhibition of protein synthesis, leading to apoptosis of malignant cells. Its unique mode of action and niche market positioning significantly influence its market dynamics and financial prospects.

Market Overview

Therapeutic Landscape and Market Need

Chronic myeloid leukemia is a clonal myeloproliferative disorder characterized by the Philadelphia chromosome. The advent of TKIs such as imatinib revolutionized CML management, substantially improving survival rates. However, a subset of patients develops resistance or intolerance to TKIs, creating demand for alternative treatments like Omacetaxine Mepesuccinate [1].

As of 2023, the global CML treatment market is valued at approximately USD 7 billion, driven by increasing diagnosis rates and expanding indications for existing therapies. Yet, the niche for Omacetaxine remains limited to a subset—patients with TKI resistance, estimated to constitute roughly 10-15% of the total CML population [2].

Market Penetration

Since its FDA approval in 2012, Omacetaxine Mepesuccinate has maintained a relatively stable but modest market share due to several factors:

• Limited Indication Scope: Its approval is primarily for resistant or intolerant CML cases.

• Competitive Landscape: Though effective, other agents like ponatinib and newer therapies are emerging, offering alternative options.

• Physician Adoption: Adoption rates depend heavily on clinicians’ familiarity and comfort with sequencing therapies in resistant cases.

Market Drivers

• Unmet Medical Need: A significant number of patients remain resistant to TKIs.

• Regulatory Approvals in Other Regions: Expansion into European markets could elevate sales.

• Combination Therapy Potential: Investigations into combining Omacetaxine with other agents could expand its use cases.

Financial Trajectory

Revenue Projections

Omacetaxine Mepesuccinate's annual global sales have been relatively steady, hovering around USD 100-150 million. Growth prospects hinge on several factors:

• Market Expansion: Approvals in additional jurisdictions could increase revenue, especially in regions with high CML prevalence such as China and Europe.

• Label Expansion: Clinical trials exploring its efficacy in other hematological malignancies may facilitate label expansion.

• Competitive Pressure: The rising pipeline of novel agents may cap future growth.

Cost and Pricing Dynamics

Current pricing per treatment course varies by region but generally ranges between USD 6,000 and USD 10,000. Given its niche application, price pressure is moderate, yet payor resistance in certain markets could impact profitability.

R&D expenses for Omacetaxine are primarily related to clinical trials, manufacturing scale-up, and regulatory compliance. As patent protections wane or if biosimilars emerge, pricing power may diminish.

Competitive and Regulatory Factors

• Patent Status: Omacetaxine's patent protection has largely expired, opening potential for biosimilar or generic competitors, which could lead to price erosion.

• Regulatory Environment: Stringent regulatory pathways, especially in emerging markets, may delay or restrict expansion, impacting revenue.

• Pipeline Evolution: The development of next-generation TKIs and combination therapies could reduce dependence on Omacetaxine.

Key Challenges and Opportunities

Challenges

• Limited Patient Pool: Narrow indication constrains growth.
• Emerging Therapies: Newer agents with more convenient administration or broader indications threaten market share.
• Biosimilar Competition: Price erosion risks due to biosimilars post-patent expiry.

Opportunities

• Expanding Indications: Research into treating other hematologic malignancies may unlock new markets.
• Regional Expansion: Greater penetration in non-U.S. markets could boost revenues.
• Combination Regimens: Clinical trials exploring synergy with other agents can enhance efficacy and market appeal.

Future Financial Outlook

Analysts project that sales of Omacetaxine Mepesuccinate could plateau in the next 3-5 years unless significant label expansions or geographical market penetrations occur. With strategic investments in clinical development and market access, annual revenues could incrementally grow to USD 200 million by 2028, representing a Compound Annual Growth Rate (CAGR) of approximately 10-12%. Conversely, patent expirations and biosimilar entry could accelerate revenue decline, necessitating diversification strategies.

Regulatory and Market Entry Considerations

Accelerated approval pathways or orphan drug designations in targeted markets may facilitate quicker market access, boosting medical and financial value. Engagement with payors through value-based pricing models could improve reimbursement and uptake.

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Key Takeaways

• Niche Market Dependency: Omacetaxine Mepesuccinate’s success is tied to its role in resistant TKI-intolerant CML patients, positioning it as a niche product with limited upside unless expanded through clinical trials or geographical penetration.

• Market Expansion is Crucial: Regional regulatory approvals, particularly in Europe and Asia, hold significant potential for revenue growth.

• Competitive Landscape Risk: The emergence of next-generation hematologic therapies and biosimilars presents ongoing threats requiring strategic positioning.

• Cost Management and Pricing Strategies: Maintaining favorable pricing amid biosimilar threats and healthcare payor pressures is vital for sustained profitability.

• Clinical Development and Label Expansion: Investing in research to explore new indications and combination therapies can diversify revenue streams.

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FAQs

1. What are the primary therapeutic advantages of Omacetaxine Mepesuccinate?
Omacetaxine directly inhibits protein synthesis, leading to apoptosis in CML cells resistant to traditional TKIs. Its unique mechanism offers an effective option for patients with TKI resistance or intolerance.

2. How does the patent landscape affect Omacetaxine’s market prospects?
Patent expiration opens opportunities for biosimilar competition, which could reduce pricing and sales. Strategic patent extensions or formulations may delay biosimilar entry, extending market exclusivity.

3. What regions show the most promise for market expansion?
European markets and China are key targets due to high CML prevalence and regulatory receptivity, where approval and reimbursement pathways are more accessible compared to some emerging economies.

4. Are there ongoing clinical trials that could expand Omacetaxine’s approval?
Yes, ongoing studies are examining its efficacy in other hematological disorders, which could lead to label broadening if results are positive.

5. What strategic moves can pharmaceutical companies pursue to maximize Omacetaxine’s financial potential?
Engaging in research for new indications, pursuing regional approvals, optimizing pricing within payor frameworks, and developing combination therapies are critical strategies.

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References

1. American Cancer Society. "Chronic Myeloid Leukemia (CML)." Accessed 2023.
2. MarketsandMarkets. "Global Hematological Malignancy Drugs Market." 2023.
3. FDA. “Synribo (Omacetaxine Mepesuccinate) Approval and Label Information,” 2012.