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
Teva Pharmaceutical Industries, Ltd.	Phase 1/Phase 2
University of Florida	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
Germany	69923768
Canada	2459822	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)
Canada	2324895

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Synribo

Last updated: July 27, 2025

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Introduction

Synribo (omacetaxine mepesuccinate) is an FDA-approved chemotherapy agent developed by Teva Pharmaceutical Industries, primarily indicated for the treatment of chronic or accelerated phase chronic myeloid leukemia (CML) in patients resistant or intolerant to at least two tyrosine kinase inhibitors (TKIs). Since its approval, Synribo's commercial trajectory has been shaped by evolving market dynamics, competitive landscape, regulatory influences, and clinical developments, all contributing to its financial outlook.

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Market Context and Therapeutic Landscape

The CML market has undergone transformative shifts with the advent of targeted kinase inhibitors. First-generation drugs like imatinib revolutionized treatment, extending median survival significantly. However, resistance and intolerance issues led to second-generation TKIs (dasatinib, nilotinib) and third-generation agents (ponatinib), creating a highly competitive environment [1].

Synribo occupies a niche for treatment-resistant CML cases, specifically in patients who cannot tolerate or develop resistance to TKIs. Its unique mechanism—protein synthesis inhibition via epigenetic modulation—differentiates it from TKIs, positioning it as a second- or third-line therapy. Nevertheless, the limited scope of its approved indication constrains its market penetration.

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Market Dynamics

1. Competitive Landscape

Despite advances, resistance to TKIs remains a clinical challenge, creating demand for alternative therapies like Synribo. However, its market share is limited due to the following:

• Emergence of Novel Agents: Newer therapies, including asciminib (a STAMP inhibitor) and combination regimens, are expanding options for resistant CML patients. These agents could potentially border or replace Synribo in certain cases, impacting its long-term market share [2].

• Orphan Drug Status: Synribo's FDA approval as an orphan drug provides benefits such as market exclusivity for seven years, albeit limited scope. The exclusivity period's expiration may introduce generic competition or biosimilar entries, affecting revenues.

• Clinical Guidelines and Adoption: Treatment guidelines increasingly favor TKIs and their combinations. Use of Synribo remains confined to niche patient populations, limiting extensive adoption.

2. Regulatory and Pricing Environment

Pricing for Synribo remains premium due to its targeted indication and mode of action. Regulatory frameworks emphasizing cost-effectiveness and value-based pricing could exert downward pressures.

Additionally, value-based assessments by payers constrain reimbursement premiums. In markets with cost-containment policies (e.g., Europe, the US), reimbursement dynamics are critical for sales stability.

3. Clinical Development and Label Expansion

Efforts to extend Synribo’s indication to broader or earlier-stage disease could positively influence demand. However, ongoing clinical trials and outcomes data are essential for such expansion. To date, limited new data have surfaced, constraining growth prospects.

4. Manufacturing, Supply Chain, and Market Penetration

Manufacturing complexities and supply chain stability influence availability and pricing. Given the concentrated nature of its indication, market penetration remains modest outside specialized centers, especially given competition from more accessible oral TKIs.

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Financial Trajectory Analysis

1. Current Revenue Performance

Synribo’s sales, historically modest due to its niche application and competition, have been stable but limited. For FY 2022, Teva reported Synribo revenues in the mid-hundreds of millions USD, reflecting steady, if restrained, demand. The drug’s revenue is sensitive to factors like pricing strategies, treatment guidelines, and market acceptance.

2. Impact of Patent and Exclusivity Periods

Synribo benefits from patent protections and orphan drug status, with exclusivity potentially lasting until 2027. The patent cliff nearing expiration could open markets to biosimilars or generics, pressuring prices and reducing revenues unless supplemented by indications or market expansion.

3. R&D and Clinical Pipeline Investment

Teva continues investing in clinical research to support label expansion or combination strategies involving Synribo. These initiatives, if successful, could redefine its financial trajectory, either positively through expanded markets or negatively if clinical trials fail to meet endpoints.

4. Market Growth and Future Projections

Considering the limited expansion potential and ongoing resistance issues, forecasts estimate modest CAGR growth (around 2-3%) over the next five years. Market saturation and increasing competition from emerging therapies could suppress growth further.

5. Strategic Opportunities and Risks

Opportunities include:

• Label expansion: Trials exploring Synribo for other hematologic malignancies or earlier-stage CML could broaden its market.
• Combination therapies: Demonstrating synergistic effects with TKIs might reposition Synribo as part of first-line regimens.

Risks involve:

• Market erosion due to generic competition post-patent expiry.
• Clinical setbacks in ongoing trials.
• Price pressures from payers demanding value-based pricing.

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Regulatory and Market Trends Shaping the Future

Regulatory bodies focus increasingly on innovative, targeted therapies with clear value propositions. The trend toward personalized medicine aligns with Synribo’s niche profile but also requires demonstrating improved clinical outcomes to justify premium pricing.

Global market access remains key, with potential growth in emerging markets where the burden of resistant CML is rising, and access to costly TKIs is limited. However, price sensitivity and regulatory hurdles in these regions could temper expansion.

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Conclusion

Synribo's market dynamics are characterized by limited but stable demand driven by treatment-resistant CML cases. Its financial trajectory hinges on patent life, clinical developments, and evolving treatment paradigms. While current revenues are modest, strategic positioning—via clinical trial success and potential indication expansion—could enhance its market footprint. Nonetheless, competitive pressures, alternative therapies, and regulatory trends pose ongoing challenges to sustained growth.

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Key Takeaways

• Niche Positioning: Synribo remains a critical treatment for resistant CML but faces limited growth due to competition and treatment paradigm shifts.
• Patent and Market Exclusivity: Patent expiration and upcoming biosimilar entries threaten revenue stability, emphasizing the importance of market expansion initiatives.
• Clinical Development: Successful trials for indication expansion or combination therapies could significantly alter Synribo’s financial outlook.
• Pricing and Reimbursement: Value-based pricing strategies are essential to maintain profitability amid price regulation and payer pressures.
• Market Expansion Opportunities: Growing CML burden in emerging markets presents a strategic avenue, albeit intertwined with regulatory challenges.

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FAQs

1. What are Synribo’s primary competitors in the CML treatment landscape?
Synribo's main competitors are newer TKIs such as ponatinib, asciminib, and combination strategies involving established TKIs, which have broader indications and easier oral administration.

2. Can Synribo be used as a first-line therapy for CML?
Currently, no. Synribo is approved specifically for resistant or intolerant cases in the advanced phases of CML, limiting its use to second- or third-line settings.

3. What impact will patent expiration have on Synribo’s revenues?
Patent and exclusivity periods are set to expire around 2027, risking generic entry and significant revenue erosion unless the company expands its indications or develops new formulations.

4. Are there ongoing clinical trials to expand Synribo’s use?
Yes, Teva and collaborators are exploring combination therapies and potential new indications, but conclusive results are pending and may influence future market potential.

5. How might regional market differences affect Synribo’s sales?
In regions with high treatment-resistant CML prevalence and limited access to TKIs, Synribo could see increased adoption. Conversely, stringent pricing controls or competing therapies in developed markets could suppress sales growth.

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References

[1] Baccarani et al., "European LeukemiaNet Recommendations for the Management of Chronic Myeloid Leukemia," Blood, 2013.
[2] Hughes et al., "Emerging Therapies for Resistant CML," J Hematol Oncol, 2022.