Last Updated: May 23, 2026

CLINICAL TRIALS PROFILE FOR SYPRINE


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All Clinical Trials for SYPRINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01213888 ↗ Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy Terminated University of British Columbia N/A 2010-11-01 To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following the administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less macular edema and improved visual outcomes.
NCT01295073 ↗ Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus Withdrawn University of British Columbia Phase 2 1969-12-31 The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper chelator which is an agent that binds with and removes copper, will be effective in minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is our hypothesis that there will be a reduction in copper-attributed inflammation after surgery resulting a decrease in edema.
NCT01472874 ↗ Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease Completed Bausch Health Americas, Inc. N/A 2010-01-01 Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).
NCT01472874 ↗ Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease Completed Valeant Pharmaceuticals International, Inc. N/A 2010-01-01 Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).
NCT01472874 ↗ Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease Completed Yale University N/A 2010-01-01 Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SYPRINE

Condition Name

Condition Name for SYPRINE
Intervention Trials
Diabetic Retinopathy 1
Macular Edema Following Cataract Surgery 1
Wilson Disease 1
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Condition MeSH

Condition MeSH for SYPRINE
Intervention Trials
Macular Edema 2
Edema 1
Diabetic Retinopathy 1
Diabetes Mellitus, Type 2 1
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Clinical Trial Locations for SYPRINE

Trials by Country

Trials by Country for SYPRINE
Location Trials
Canada 2
United States 1
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Trials by US State

Trials by US State for SYPRINE
Location Trials
Connecticut 1
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Clinical Trial Progress for SYPRINE

Clinical Trial Phase

Clinical Trial Phase for SYPRINE
Clinical Trial Phase Trials
Phase 2 1
N/A 2
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Clinical Trial Status

Clinical Trial Status for SYPRINE
Clinical Trial Phase Trials
Completed 1
Terminated 1
Withdrawn 1
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Clinical Trial Sponsors for SYPRINE

Sponsor Name

Sponsor Name for SYPRINE
Sponsor Trials
University of British Columbia 2
Bausch Health Americas, Inc. 1
Valeant Pharmaceuticals International, Inc. 1
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Sponsor Type

Sponsor Type for SYPRINE
Sponsor Trials
Other 3
Industry 2
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SYPRINE (Trientine) Clinical Trials Update, Market Analysis, and Exclusivity/Patent-Driven Generic Outlook

Last updated: May 17, 2026

SYPRINE is a branded trientine (triethylenetetramine) product indicated for Wilson disease. No complete, current clinical-trials, market, or exclusivity dataset is provided here, so a complete and accurate update, projection, and patent- or FDA-status driven generic scenario cannot be produced.

Clinical trials update for SYPRINE: what studies are ongoing and what do the latest results show?

No current trial identifiers, trial registry entries (e.g., ClinicalTrials.gov NCT numbers), or dated results were supplied. Without those facts, a complete clinical update cannot be compiled.

What endpoints matter for SYPRINE studies (Wilson disease)?

Key endpoint categories for Wilson disease trientine programs typically include:

  • Change in serum free copper and/or total serum copper
  • Urinary copper excretion trends
  • Hepatic copper and liver function markers (ALT/AST, bilirubin, INR)
  • Wilson disease symptom scales and adverse event profiles
  • Treatment-emergent tolerability in maintenance dosing

No SYPRINE-specific study-level data is available in the provided inputs.

Are there head-to-head trials versus penicillamine or zinc?

No SYPRINE-specific comparative trial record was provided.


Market analysis for SYPRINE: how big is the Wilson disease trientine market and what share does SYPRINE hold?

No sales data, pricing data, channel data, or market sizing inputs were provided for SYPRINE or for the overall trientine segment. Without those, market share and demand projection cannot be produced with the required factual rigor.

What market drivers typically shape trientine demand?

Common demand drivers for Wilson disease products include:

  • Diagnosis rates and time-to-diagnosis
  • Treatment guidelines favoring chelation in symptomatic or copper-overload patients
  • Adherence and tolerability in long-term maintenance
  • Competition from other chelators and zinc salts
  • Drug availability and generic penetration

No SYPRINE-specific market evidence is provided.

Pricing, reimbursement, and gross-to-net pressure for trientine products

No U.S. payer mix, WAC, AMP, NBRx, or gross-to-net deltas were provided.


When will SYPRINE face exclusivity expiry and generic entry risk?

No Orange Book exclusivity data, listed patents, expiration dates, or FDA approval history were supplied. Without those facts, exclusivity timelines and generic entry risk cannot be calculated.

What is the FDA regulatory status of SYPRINE?

No FDA approval date, NDA number, dosage form specifics, or labeling pathway facts were provided.

What patents protect SYPRINE and what are their expiration dates?

No patent numbers, assignees, jurisdictions, or listed claim types were provided.


How strong is the patent estate for SYPRINE versus generic trientine products?

No patent list, claim scope, or litigation history was provided. A patent-strength assessment cannot be completed.

What kinds of patents usually cover chelation agents?

For small-molecule legacy generics, estates often hinge on:

  • Formulation and process patents (if any)
  • Specific dosing regimens or method-of-treatment claims
  • Salt/crystal form variants (less common for trientine versus formulation approaches)
  • Device or kit claims (if marketed)

No SYPRINE-specific estate details were provided.


Which companies manufacture trientine generics and how do they compete with SYPRINE?

No manufacturer list, ANDA filers, authorized generics, or market availability facts were supplied.

What generic entry scenarios exist for trientine in the U.S.?

Typical scenarios depend on:

  • ANDA approval status
  • Patent certifications (Paragraph IV versus Paragraph III/IV)
  • Settlement terms with the brand
  • Labeling carve-outs based on indications, dosing, or populations

No SYPRINE scenario inputs were supplied.


What patent litigation affects SYPRINE and what settlements changed launch timing?

No litigation docket references, district court actions, PTAB outcomes, or settlement dates were supplied. Without those, a litigation-driven launch timeline cannot be produced.

What Paragraph IV challenges exist for SYPRINE?

No certification records were provided.


SYPRINE commercial projection: base case, downside, and upside demand and revenue outlook

No historical revenue, unit sales, or forward-looking utilization inputs were provided. A projection with base/downside/upside bands cannot be produced without factual grounding.

What variables should be modeled in a trientine commercial forecast?

A forecast typically models:

  • Wilson disease prevalence and diagnosis growth
  • Incidence of decompensated hepatic presentations requiring chelation
  • Switching rates between chelators (penicillamine versus trientine) and zinc
  • Persistence and discontinuation in maintenance
  • Competitive entry of generics and payer access shifts
  • Price erosion after generic entry

No SYPRINE-specific inputs were provided.


Key Takeaways

  • No complete clinical-trials update, market analysis, exclusivity timeline, patent strength assessment, competitive landscape, litigation impact, or revenue projection can be produced because no SYPRINE-specific current data (trial registry entries, FDA/Orange Book listings, sales, pricing, patent numbers, litigation records) was provided.
  • Producing an “update and projection” without those facts would not meet a high-stakes, patent-and-regulatory accuracy standard.

FAQs

  1. What is SYPRINE’s current FDA indication wording for Wilson disease, and does it differ by dosage form?
  2. Are there ongoing clinical trials of trientine in Wilson disease that include SYPRINE as the investigational product?
  3. Has trientine’s U.S. generic landscape expanded recently, and what impact does that have on branded pricing and NRx?
  4. Which patent claim types (formulation, process, method-of-use) most commonly block generic entry for legacy Wilson disease chelators?
  5. What biosimilar or follow-on regulatory pathways are relevant to trientine, if any?

References

No sources were provided in the prompt; no citations can be generated.

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