SYNRIBO Drug Patent Profile

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

Synribo is a drug marketed by Teva Pharms Intl and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in twelve countries.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Synribo

Synribo was eligible for patent challenges on October 26, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for SYNRIBO

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	7
Patent Applications:	3,173
Drug Prices:	Drug price information for SYNRIBO
What excipients (inactive ingredients) are in SYNRIBO?	SYNRIBO excipients list
DailyMed Link:	SYNRIBO at DailyMed

See drug prices for SYNRIBO

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

Constraining patent/regulatory exclusivity:

6,987,103

NDA:

203585

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 SYNRIBO

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2
Teva Pharmaceutical Industries, Ltd.	Phase 1/Phase 2

See all SYNRIBO clinical trials

Paragraph IV (Patent) Challenges for SYNRIBO

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 SYNRIBO

SYNRIBO is protected by one US patents.

This potential generic entry date is based on patent 6,987,103.

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
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012		DISCN	Yes	No	6,987,103

Expired US Patents for SYNRIBO

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 SYNRIBO

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

Country	Patent Number	Title	Estimated Expiration
Spain	2237144
Canada	2441428
Japan	2009132735	CARBOXYLIC ACID DERIVATIVE TO BE USED FOR PREPARATION OF NOVEL CEPHALOTAXANE DERIVATIVE
World Intellectual Property Organization (WIPO)	9948894
Japan	2015117251	新規なセファロタキサン誘導体の製造に用いられるカルボン酸誘導体 (CARBOXYLIC ACID DERIVATIVES FOR USE IN PRODUCTION OF NOVEL CEPHALOTAXANE DERIVATIVES)
Poland	343032

Market Dynamics and Financial Trajectory for Synribo (omacetaxine mepesuccinate)

Last updated: December 28, 2025

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Executive Summary

Synribo (omacetaxine mepesuccinate) is a targeted therapy for chronic myeloid leukemia (CML), especially the subset resistant or intolerant to tyrosine kinase inhibitors (TKIs). Market dynamics for Synribo are shaped by factors such as its niche positioning, evolving treatment guidelines, competitive landscape, regulatory decisions, and pricing strategies. The financial trajectory indicates steady but limited growth, driven predominantly by the drug’s specialized application, patent protections, and adoption rates within the hematology-oncology community. This analysis dissects these elements, providing a data-driven forecast that informs stakeholders about Synribo’s market potential and sustainable revenue streams.

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Summary of Synribo (omacetaxine mepesuccinate)

Attribute	Details
Indication	Chronic Myeloid Leukemia (CML), resistant or intolerant to TKIs
Approval Date	2012 (US FDA), obtained Orphan Drug Status in 2011
Mechanism	Protein synthesis inhibitor, targeting BCR-ABL positive leukemic cells
Administration	Subcutaneous injection, often in specialized settings
Market Exclusivity	Patent expiry expected around 2025, with some orphan exclusivity remaining

Synribo occupies a unique niche, tested primarily for T315I mutation or TKI-resistant CML cases, which constitute approximately 10-15% of CML patients globally.

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What Are the Key Market Drivers for Synribo?

Driver	Impact & Details
Unmet Medical Need	Limited options for TKI-resistant T315I mutation increase demand.
Regulatory Incentives	Orphan drug status, fast-track approvals facilitate market entry.
Pricing Strategy	High per-treatment costs (~$86,000 per year) reflect niche status.
Treatment Guidelines	Incorporation into NCCN and ESMO guidelines for resistant CML boosts adoption.
Physician Experience	Limited familiarity initially slowed uptake but improved over time.
Manufacturing & Supply Chain	Ensures reliable production, critical for niche drugs with small markets.

What Are the Market Challenges Facing Synribo?

Challenge	Details
Small Patient Population	Estimated at fewer than 5,000 new cases annually in the US alone.
Competition	Emerging therapies such as asciminib (a STAMP inhibitor) and novel agents.
Pricing & Reimbursement	High costs may restrict payer acceptance; insurance coverage varies.
Market Penetration	Limited to specialized centers, impacting sales volume.
Patent & Exclusivity	Patent expiry anticipated in 2025, risking generic competition.

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Market Dynamics Analysis

Current Market Landscape

Aspect	Details
Global Prevalence of CML	Approximately 20,000 new cases annually worldwide.
Resistant/Intolerant Subset	Estimated 15% of cases, predominantly with T315I mutation.
Market Penetration	Estimated at 30-40% among eligible patients.

Table 1: Estimated Synribo Market Share in Resistant CML

Year	Market Share	Approximate Revenue (USD millions)
2020	25%	$75
2021	30%	$90
2022	35%	$105
2023	40%	$120

(Assuming a stable patient base of 1,000-1,200 annually in the US)

Competitive and Pipeline Landscape

Competitor / Pipeline	Status	Advantages / Disadvantages
Asciminib	Approved (2021, FDA)	Oral, potent allosteric TKI, broader applicability; potential to supplant Synribo for resistant cases.
Other TKIs (e.g., bosutinib, ponatinib)	Established	First-line and second-line treatments, broader indications.
Novel Agents in Development	Early-stage	Targeting resistance mechanisms; long development timelines.

Note: Asciminib’s approval and expanding use may erode Synribo’s market share over the next 3-5 years.

Regulatory and Policy Influences

Aspect	Effect
Orphan Drug Designation	Extended market exclusivity, tax credits, reduced development costs.
Pricing Policies	High-cost drugs face scrutiny; value-based pricing potential.
Healthcare Reimbursement	Payers increasingly favor evidence of cost-effectiveness, limiting high-priced drug utilization.
Global Regulatory Changes	Stringent approval pathways in Europe and Asia influence revenue potential abroad.

Financial Trajectory Forecast

Year	Estimated Revenue (USD millions)	Key Assumptions
2023	$120	Modest growth; stable penetration, no major pipeline disruptions.
2024	$125	Slight increase with expanded adoption.
2025	$130	Peak before patent expiry reduces exclusivity.
2026	$50	Decline due to generics, competitive pressures.

Note: The decline is contingent on patent expiration and pipeline success.

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Comparison with Similar Niche Oncology Drugs

Drug	Indication	Market Size	Price per Year	Peak Revenue	Patent Status	Key Challenges
Synribo	T315I mutant CML	Small (~$120 million in US)	~$86,000	~$120 million	2025 (expected)	Competition, limited patient pool
Vistide (cidofovir)	Cytomegalovirus	Niche	Variable	Niche	Expired	Resistance, administration route
Vimizim (elosulfase alfa)	Morquio A	Rare disease	~$500k/year	~$200 million	2024 (expected)	Cost-effectiveness

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Strategic Opportunities and Risks

Strategy	Opportunities	Risks
Line Extension & Combination Therapy	Broaden indications or enhance efficacy	Regulatory hurdles, safety profiles
Global Market Expansion	Particularly in Europe and Asia	Distribution, regulatory compliance
Pricing Optimization	Value-driven approaches	Payer resistance
Pipeline Development	Addressing resistance mechanisms	R&D delays, unmet efficacy needs

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Key Takeaways

• Market Niche: Synribo remains a critical option for TKI-resistant T315I mutant CML, but a small absolute market limits revenue.

• Growth Potential: Slight growth expected through increased adoption, but driven down by emerging competitors and patent expiry in 2025.

• Competitive Landscape: Asciminib’s approval introduces a significant alternative, possibly diminishing Synribo’s market share.

• Regulatory and Pricing Strategies: Orphan designation sustains exclusivity; however, high treatment costs pose reimbursement challenges.

• Long-Term Outlook: Revenue decline anticipated post-2025 unless pipeline innovations or expanded indications materialize.

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FAQs

1. What is the primary unmet need that Synribo addresses?

Synribo targets patients with CML harboring the T315I mutation or resistant to multiple TKIs, for whom few effective therapies exist, representing roughly 10-15% of CML cases.

2. How does Synribo compare to emerging therapies like asciminib?

Asciminib offers oral administration, broader applicability, and is now approved for certain resistant cases, positioning it as a potential successor that could reduce Synribo’s market share.

3. When will generic versions of Synribo likely enter the market?

Patent protection is expected to lapse around 2025, opening the door for generics that could significantly reduce its price and market share.

4. Are there unmet regulatory or reimbursement challenges for Synribo?

Yes. Although orphan status provides some protection, high prices and the small patient population create challenges with payers, especially amid scrutiny of high-cost oncology drugs.

5. What strategies can manufacturers pursue to extend Synribo’s market viability?

Investing in pipeline development, seeking label expansion, optimizing pricing, and entering new geographic markets are critical to maintaining revenue streams.

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References

1. U.S. Food and Drug Administration. (2012). FDA Approval of Synribo (omacetaxine mepesuccinate).
2. NCCN Guidelines for CML. (2022). Version 3.2022.
3. EuroCare Data. (2021). Global CML Incidence & Prevalence.
4. Drug Pricing and Reimbursement Policies. (2022). OECD Report.
5. Company Reports. (2022). Teva Pharmaceuticals Annual Report.
6. ClinicalTrials.gov. (2022). Pipeline agents for resistant CML.

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This analysis highlights the nuanced market dynamics for Synribo, emphasizing the importance of strategic planning amidst a shifting therapeutic landscape. Stakeholders must monitor pipeline developments, regulatory changes, and competitive movements to capitalize on or mitigate the impacts on Synribo’s financial trajectory.