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:	2,737
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

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.

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

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

International Patents for SYNRIBO

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

Country	Patent Number	Title	Estimated Expiration
Austria	451106
Austria	548041
Australia	2002337410
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)
Cyprus	1109799
Cyprus	1112817
Germany	60234708

Synribo (omacetaxine mepesuccinate) market dynamics and financial trajectory: exclusivity, competitive risk, and revenue outlook

Last updated: June 4, 2026

Synribo (omacetaxine mepesuccinate) is a niche, high-cost oncology product with a concentrated patient pool in chronic myeloid leukemia (CML) settings and a smaller footprint in other hematologic indications where applicable. Commercial dynamics are driven by guideline positioning after resistance/intolerance to tyrosine kinase inhibitors (TKIs), strict use patterns, limited prescriber familiarity, and heavy buyer scrutiny due to cost per course. Financial trajectory is characterized by modest-to-flat peak sales with sensitivity to treatment sequencing, access coverage, and loss-of-exclusivity or label changes affecting eligibility.

What is Synribo’s commercial profile (sales drivers, patient pool, pricing, and payor dynamics)?

Synribo is an injectable omacetaxine mepesuccinate therapy marketed for specific CML populations. Its commercial profile has three practical determinants: (1) narrow indication targeting and sequencing, (2) administration and monitoring burden versus oral TKIs, and (3) payer economics tied to short-course dosing cycles and high acquisition cost.

How does patient eligibility shape demand?

Demand concentrates among patients with:

• CML who are resistant or intolerant to prior TKIs.
• Patients for whom additional lines of TKI therapy are not viable due to resistance mechanisms or adverse events.
• Populations where clinicians prefer a non-TKI mechanism when disease control fails.

Because eligibility is conditional on prior treatment history, volumes depend more on the size and kinetics of resistant/intolerant CML cohorts than on overall CML incidence.

What are the key market forces that affect uptake?

• Treatment sequencing: Oral TKIs hold the dominant first-line and major second-line positions in CML. Synribo uptake rises mainly when sequencing shifts due to documented resistance or intolerance.
• Formulary access: Because Synribo is expensive per course, managed care coverage decisions heavily influence realized net price.
• Site-of-care and administration: Injectable chemotherapy-style workflows can slow adoption relative to oral competitors even when clinical benefit is clear.
• Budget impact pressure: Oncology pharmacy and medical benefit arrangements can change patient start rates after payer edits.

How has Synribo’s financial trajectory looked historically (revenue trend and volatility)?

Synribo’s financial trajectory is expected to track a “niche oncology” shape: limited growth ceiling, periodic step-down when market access tightens or competitors gain share, and revenue volatility tied to CML subgroup movement and payer coverage.

What drives year-to-year sales variance?

• Patient mix within resistant/intolerant CML.
• Prior TKI exposure depth and how quickly physicians switch out of TKIs.
• Competitive messaging from TKI updates and alternative mechanisms.
• Payer step therapy and prior authorization changes.
• Changes in administration practice that affect ease-of-use for hospital formularies.

What are the typical revenue risks for a niche injectable oncology drug?

• Loss of share if guideline frameworks favor alternative agents.
• Reduction in net price from rebate pressure and contract renegotiations.
• Lower utilization if payers cap non-preferred regimens.
• Slow uptake in community settings if academic centers reduce protocol emphasis.

When does Synribo lose exclusivity and what patents govern market protection?

Synribo’s market protection is determined by the combination of:

• Composition-of-matter patents on omacetaxine mepesuccinate (drug substance).
• Formulation and manufacturing method patents for the injectable product.
• Potential method-of-use patents tied to CML regimens where applicable.
• Exclusivity attached to regulatory approvals (data exclusivity, marketing exclusivity) and patent life.

This protection stack governs when generic manufacturers can legally file and when they can launch, with the practical window set by the latest expiring patent that blocks approval or that controls the approval pathway.

How do Orange Book listings determine generic entry timing?

• FDA Orange Book lists patents eligible for enforcement in the approval context.
• Generic entry risk generally maps to the earliest “first expiring” relevant Orange Book patent combined with any exclusivity that blocks approval.

What is the practical timeline for generic risk?

For niche injectables like Synribo, the timeline depends on whether any later-expiring formulation or method patents remain listed and enforceable. Absent a later-expiring barrier, biosimilar-style dynamics do not apply; instead, the critical pathway is generic small molecule approval if a carve-out exists in patent coverage. In the Synribo case, the market risk is usually composition and formulation barriers, not biologic substitution.

What patents protect Synribo (omacetaxine mepesuccinate), and how strong is the estate?

A full “patent estate” strength assessment requires an Orange Book-to-patent mapping with expiration dates and legal status. That analysis depends on Synribo’s current listed patents and active litigation records.

Because the prompt does not include Synribo’s specific Orange Book patent list (numbers, assignees, expiration dates) or any confirmed litigation docket data, a complete and accurate patent-by-patent strength evaluation cannot be produced here.

How do Paragraph IV challenges and FDA pathway choices affect Synribo’s competitive landscape?

For a small molecule injectable, the competitive entry pathway is generally generic 505(j) with reliance on bioequivalence and submission of patent certifications to FDA-listed patents. If a manufacturer files with certifications that dispute patent validity or non-infringement, Paragraph IV litigation can be triggered.

What are the typical effects of Paragraph IV litigation on Synribo’s revenue?

• Extended “at-risk” delays: Even if a generic is ready, court injunctions or settlement agreements can delay launch.
• Settlement licensing: Settlements can include non-competition terms that hold market exclusivity for the innovator.
• Contract and formulary shock: Payer switching to generic can occur quickly at launch if coverage policies are favorable and supply is stable.

What FDA approval pathway details matter for investors?

• Whether entry is blocked by listed patents or exclusivity.
• Whether the generic qualifies for approval without clinical endpoints that could change labeling or clinical positioning.
• Whether the entrant seeks an authorized generic or agreement-driven supply.

What is the Orange Book status of Synribo and what does it imply for generic launch risk?

Orange Book status typically answers:

• Which patents are still listed as of the current date.
• What they are protecting (drug substance, formulation, method of use).
• The last patent expiration that can block approval for a generic applicant.

The prompt does not provide the Orange Book patent list for Synribo, so a definitive Orange Book status summary and a launch-risk schedule cannot be stated without risking error.

How does Synribo compare with competing CML therapies (TKIs and other injectables)?

Synribo competes in CML lines after resistance or intolerance to TKIs rather than in earlier-line settings dominated by oral TKIs. The competitive “decision tree” is typically:

1. First-line and common second-line treatment with TKIs.
2. Switching among TKIs or switching to alternate mechanisms when resistance/toxicity emerges.
3. Use of Synribo in narrower subgroups where it is clinically justified and accessible.

Where does Synribo win commercially?

• When resistance/toxicity limits further TKI selection.
• When clinicians seek a non-TKI mechanism after prior exposures.
• When disease course supports a short, cycle-based intervention rather than a continued oral approach.

Where does Synribo lose commercially?

• When clinicians default to updated TKIs or alternative options earlier.
• When payer coverage makes Synribo non-preferred relative to oral alternatives.
• When real-world administration friction reduces initiation despite eligibility.

What formulation or manufacturing IP barriers could block generic Synribo entry?

For injectables, generic entry risk often concentrates on:

• Proprietary formulation parameters affecting stability, viscosity, and reconstitution.
• Sterility assurance and manufacturing controls.
• Particle size distribution, container closure system compatibility, and shelf-life controls.

These can extend time-to-approval and raise CMC burden. Without Synribo’s specific formulation patents and manufacturing process claims, the exact barriers cannot be enumerated here.

What patent litigation affects Synribo (lawsuits, settlements, injunctions)?

Patent litigation materially shapes commercial outcomes for niche products by:

• delaying approval,
• forcing design-around or labeling carve-outs,
• and creating settlement-driven non-competition.

The prompt does not supply docket numbers, case captions, filing dates, or settlement terms. A precise litigation impact assessment cannot be produced.

What generic entry risks exist for Synribo (market timing and uptake scenarios)?

Generic entry risk for Synribo depends on the combination of:

• whether an ANDA can clear Orange Book barriers,
• whether Paragraph IV litigation delays launch,
• and whether a settlement caps market entry dates.

Commercial uptake post-launch depends on:

• payer switch behavior,
• hospital formulary inertia,
• and patient-level continuity of care.

A scenario model (best/base/worst) requires actual exclusivity and patent expiration dates and the current competitive set. Those inputs are not provided.

What is Synribo’s biosimilar or biologics risk?

Synribo is a small molecule therapy (omacetaxine mepesuccinate) and does not face biosimilar substitution dynamics that apply to biologics. The relevant competitive threat is generic small molecule entry, not biosimilar competition.

Key Takeaways

• Synribo is a niche oncology injectable whose market is driven by resistant/intolerant CML sequencing rather than broad first-line adoption.
• Financial trajectory is typically modest with volatility from payer coverage and treatment sequencing.
• Generic competition risk is controlled by Synribo’s Orange Book patent and exclusivity stack, which determines ANDA timing and potential launch dates.
• A precise patent-litigation-driven launch forecast requires Synribo’s current Orange Book patent list and litigation records; those are not included in the prompt, so only general dynamics can be stated.

FAQs

1. What factors most influence Synribo utilization in resistant/intolerant CML?
   Patient eligibility after prior TKI failure, physician switching patterns, and payer authorization and formulary status.

2. Does Synribo face biosimilar competition?
   No, as it is a small molecule therapy; the key risk is generic small molecule entry.

3. How do payers typically manage coverage for high-cost injectable oncology drugs like Synribo?
   Prior authorization, step edits, and rebate-driven net price adjustments tied to budget impact controls.

4. What would a successful generic launch do to Synribo’s revenue?
   It would likely compress net pricing quickly unless prevented by listed patents, exclusivity, or settlement-based non-competition.

5. Why can patent expiry timing matter more than overall market size for Synribo?
   Because demand is concentrated in a narrow, sequenced patient cohort, and entry barriers can dominate incremental revenue more than broader demand growth.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Website).
2. FDA. Drug Approval Reports and related application information. U.S. Food and Drug Administration. (Website).