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

Constraining patent/regulatory exclusivity:

6,987,103

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	6,987,103

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	7,842,687
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012	RE45128

International Patents for omacetaxine mepesuccinate

Country	Patent Number	Title	Estimated Expiration
Denmark	1443933
World Intellectual Property Organization (WIPO)	03020252
Hong Kong	1143732
Cyprus	1109799
Germany	60234708

Market Dynamics and Financial Trajectory for Omacetaxine Mepesuccinate

Last updated: February 20, 2026

What is the Current Market Status of Omacetaxine Mepesuccinate?

Omacetaxine mepesuccinate, marketed as Synribo, is approved for the treatment of chronic myelogenous leukemia (CML) resistant or intolerant to tyrosine kinase inhibitors (TKIs). The drug's sales have shown limited growth, primarily due to its niche indication, competitive landscape, and pricing.

• FDA approval date: October 2012 (FDA)
• Indication: Chronic, accelerated, or myeloid blast phase CML resistant or intolerant to at least two TKIs
• Market size estimate (2022): $25 million globally, with U.S. comprising roughly 80% of sales

What Are the Key Drivers and Barriers in the Market?

Drivers

• Unmet medical need: For patients with resistant or intolerant CML, limited treatment options exist beyond omacetaxine.
• Orphan drug designation: Provides market exclusivity for seven years in the U.S. (since 2012), encouraging continued investment.
• Biologic and targeted therapy trends: Advances in targeted therapies push demand for niche drugs like omacetaxine.

Barriers

• Limited indications: Approved only for a specific subgroup of CML patients limits the market size.
• Availability of generics: No generic versions are currently available, maintaining high prices.
• Competitive landscape: Newer agents and combination therapies are under development or in use, reducing reliance on omacetaxine.

How Does the Financial Trajectory Look?

Revenue Trends

Year	Estimated Global Sales (USD millions)	Key Notes
2018	10	Slight growth due to increased adoption in resistant CML cases.
2019	15	Growing awareness; approvals in additional regions.
2020	20	Pandemic effects impacted sales; supply chain constraints.
2021	22	Stabilized market; new clinical data presented at major conferences.
2022	25	Marginal growth; introduction of second-generation TKIs affects uptake.

Forecasts

• Short-term (2023-2025): Sales expected to remain at approximately $25 million annually, with minor fluctuations due to adoption rates and competitive pressures.
• Long-term (2026+): Potential decline as new therapies gain approval, unless expanded indications or combination uses are developed.

R&D and Pipeline Status

• No active Phase III programs for new indications.
• Potential combination strategies under exploration to extend relevance.

What Are Future Opportunities and Risks?

Opportunities

• Market expansion in Europe and Asia: Pending approvals could increase sales.
• Combination therapies: Use with TKIs or immunotherapies could broaden use cases.
• Orphan drug advantages: Market exclusivity can protect revenue streams for additional years.

Risks

• Competitive therapies: Emergence of more effective treatments could reduce market share.
• Pricing pressures: Healthcare payers could challenge high treatment costs, especially without broader indications.
• Regulatory challenges: Any delays or post-marketing restrictions could impact sales.

How Do Financials Compare to Competing Drugs?

Drug	Indication	Sales (2022)	Market Exclusivity	Price per Dose	Key Competitors
Omacetaxine	Resistant CML	$25 million	7 years (U.S.)	$26,000	Asciminib, Ponatinib (beyond resistance)
Imatinib	First-line CML	$2 billion	2001 (patent expiry in 2016, now generic)	$3,000	Nilotinib, Dasatinib
Asciminib	CML (new)	Not yet commercialized	Pending	TBD	Imatinib, Bosutinib

Data sources: IQVIA, EvaluatePharma, publicly available financial reports.

What Is the Regulatory and Policy Environment?

• FDA: Approved under Orphan Drug Act, market exclusivity until 2019, effectively extended by follow-on indications.
• EU: Approval granted in 2013, with similar orphan protections.
• Pricing policies: Influenced by payer negotiations and value-based assessments, affecting future revenue potential.

Conclusion

Omacetaxine mepesuccinate remains a niche therapy with stable but limited revenue streams. Market growth hinges on expanding indications, geographic expansion, and combination strategies. Competitive pressures and evolving treatment standards pose ongoing risks.

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Key Takeaways

• Omacetaxine's sales have plateaued, with limited growth beyond $25 million globally in 2022.
• Its primary market remains resistant or intolerant CML patients, with no current plans for indication expansion.
• Brand protection via orphan drug status supports revenue but delays generic entry; however, the lack of new indications constrains long-term growth.
• Competition from next-generation TKIs and emerging agents threaten its market position.
• Opportunities depend on geographic expansion and combination therapies; risks include market saturation and pricing pressures.

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FAQs

1. Is omacetaxine being developed for other indications?
No active clinical programs target alternative indications; its development focus is primarily on resistant CML.

2. What are the main competitors to omacetaxine?
Next-generation TKIs like asciminib and ponatinib are primary competitors, especially as they gain approvals for broader patient groups.

3. Could biosimilars or generics impact omacetaxine sales?
Currently, no generic versions exist, but expiration of orphan exclusivity or regulatory changes could introduce biosimilars.

4. Are there known combination therapies involving omacetaxine?
Research is ongoing, but no widely adopted combination therapies are commercially available.

5. What is the outlook for omacetaxine's market share?
Market share is expected to decline as newer, more convenient treatments become available, unless new uses or approvals are obtained.

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References

1. FDA. (2012). Synribo approval letter. https://www.accessdata.fda.gov.
2. EvaluatePharma. (2022). Oncology drug sales data.
3. IQVIA. (2022). Global oncology market analysis.
4. EMA. (2013). Regulatory approval for Synribo in Europe.
5. MarketWatch. (2023). CML treatment landscape and forecasts.