CLINICAL TRIALS PROFILE FOR METHADOSE

All Clinical Trials for METHADOSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00149630 ↗	Pharmacogenetics of Disulfiram for Cocaine	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2005-01-01	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00149630 ↗	Pharmacogenetics of Disulfiram for Cocaine	Completed	Yale University	Phase 2	2005-01-01	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00149630 ↗	Pharmacogenetics of Disulfiram for Cocaine	Completed	Baylor College of Medicine	Phase 2	2005-01-01	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00573937 ↗	Methadone Versus Morphine for Cancer-Related Pain	Terminated	Mayo Clinic	Phase 2	2007-08-01	The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.
NCT00726830 ↗	Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer	Terminated	National Cancer Institute (NCI)	N/A	2009-03-01	RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.
NCT00726830 ↗	Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer	Terminated	M.D. Anderson Cancer Center	N/A	2009-03-01	RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.

Clinical Trial Conditions for METHADOSE

Condition Name

Condition Name for METHADOSE
Intervention	Trials
Pain	3
Leukemia	1
Precancerous Condition	1
Lymphoma	1

Condition MeSH

Condition MeSH for METHADOSE
Intervention	Trials
Cancer Pain	2
Opioid-Related Disorders	2
Myeloproliferative Disorders	1
Preleukemia	1

Clinical Trial Locations for METHADOSE

Trials by Country

Trials by Country for METHADOSE
Location	Trials
United States	6
Canada	4

Trials by US State

Trials by US State for METHADOSE
Location	Trials
Texas	2
New York	1
Kentucky	1
South Carolina	1
Arizona	1

Clinical Trial Progress for METHADOSE

Clinical Trial Phase

Clinical Trial Phase for METHADOSE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for METHADOSE
Clinical Trial Phase	Trials
Completed	4
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for METHADOSE

Sponsor Name

Sponsor Name for METHADOSE
Sponsor	Trials
National Cancer Institute (NCI)	2
Mayo Clinic	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for METHADOSE
Sponsor	Trials
Other	11
NIH	3

Last updated: August 1, 2026

METHADOSE clinical trials update, market analysis, and revenue projection: phase status, FDA posture, exclusivity and generic entry risk

METHADOSE (methadone hydrochloride) is a systemically delivered opioid agonist indicated for opioid use disorder and maintenance therapy. Current market value and clinical-trial momentum are materially shaped by generic availability and the drug’s long-standing, off-patent status. Clinical-trials activity is expected to be limited to incremental or reformulation studies and product-quality work rather than brand-protecting new chemical entity development.

No complete, current, source-verifiable dataset on (1) active interventional clinical trials, (2) site-level recruitment status, (3) dosing arms, and (4) near-term regulatory milestones for METHADOSE is provided in the available input. Without those hard datapoints, a complete trials-to-market projection cannot be produced.

What clinical trials are active for METHADOSE right now?

No source-anchored, current clinical-trial status can be stated from the provided information. A proper update requires present-tense trial identifiers and statuses (Recruiting/Not recruiting/Active not recruiting/Completed) tied to ClinicalTrials.gov or equivalent registries.

Are there new Phase 3 or pivotal studies for METHADOSE?

No verifiable Phase 3 or pivotal-program details are available in the provided input.

Are there bioequivalence or reformulation trials for METHADOSE?

No source-anchored bioequivalence or formulation trial identifiers are available in the provided input.

How big is the METHADOSE market and what drives demand?

A complete market sizing and driver analysis requires current utilization data, segment split (dispensing channels, geographic coverage), payer mix, and competitive set penetration for methadone HCl oral solutions in the opioid use disorder segment.

What share does METHADOSE capture vs generic methadone oral solution?

No source-anchored market share or prescription share is provided in the input.

What demand drivers matter most for methadone OUD products?

Common demand drivers for methadone maintenance include opioid use disorder incidence, retention in treatment, clinic dispensing policies, state-level program coverage, and reimbursement. Quantification for METHADOSE specifically requires audited or panel datasets not included in the input.

When will METHADOSE face reduced exclusivity or new generic entry?

METHADOSE methadone products are typically subject to generic competition long before any meaningful exclusivity horizon seen for novel drugs. A defensible exclusivity and Paragraph IV “at-risk” analysis requires an Orange Book record with listed drug code(s), application holders, expiration dates, and patent list coverage.

What is the Orange Book status of METHADOSE?

No Orange Book listing details (application number, listed patents, expiration dates) are available in the provided input.

Does METHADOSE have Orange Book patents that expire in the next 0 to 5 years?

No patent expiration schedule is provided in the input.

What patent estate protects METHADOSE and how strong is it?

A patent estate strength analysis requires identified patents, claims scope (formulation, method-of-use, manufacturing), expiration dates, and litigation or estoppel history.

Which patents protect methadone HCl oral solution products like METHADOSE?

No patent numbers, assignees, jurisdictions, or claims are provided in the input.

What patent litigation affects METHADOSE?

No litigation docket details are provided in the input.

What is the FDA regulatory posture of METHADOSE (ANDA, labeling, and REMS status)?

A regulatory posture update requires the NDA/ANDA application status, approval history, current labeling (indication, dosing, warnings), and any REMS or controlled-substance dispensing constraints tied to the specific product.

Is METHADOSE subject to a REMS?

No product-specific REMS/controlled-distribution constraints are provided in the input.

What labeling updates affect commercial adoption?

No labeling change history is provided in the input.

How does METHADOSE compare with competing methadone oral solutions for OUD?

A competitive comparison requires a product table listing active ingredients, dosage strengths, formulation type (solution vs concentrate), bottle size, dispensing form factors, substitution rules, and payer/formulary coverage.

Which brands or generics compete with METHADOSE?

No competitor list is available in the input.

How do formulary and pharmacy substitution rules affect outcomes?

No payer or pharmacy policy data is provided in the input.

Generic entry scenarios for METHADOSE: what is the risk profile?

A generic-entry risk profile requires Orange Book paragraph IV history, ANDA pipeline status, and recent approvals for methadone oral solution.

What generic entry risks exist for METHADOSE if it is already off-patent?

No Orange Book and pipeline data is provided in the input.

How do manufacturing and IP barriers impact biosimilar-like pathways?

Methadone is not a biologic; “biosimilar-like” barriers do not apply. Any barriers would be formulation, process, and labeling restrictions, which require source data not included.

Revenue projection for METHADOSE: base case, downside, upside

A credible projection requires at minimum: historical prescription volume or revenue, unit growth/decline by channel, pricing trends, competitor share movements, and regulatory or substitution events.

Base case projection (0 to 5 years)

No projection can be computed from the provided input.

Downside case (pricing compression and formulary substitution)

No scenario drivers with quantified inputs are provided in the input.

Upside case (new clinical uptake or payer coverage changes)

No payer-coverage change triggers or adoption accelerators are provided in the input.

Key Takeaways

• METHADOSE is a methadone HCl oral solution product for opioid use disorder maintenance, but current clinical-trials, Orange Book, patent, and pipeline data are not provided in the input.
• Without source-verified, up-to-date trial identifiers and regulatory/patent records, a complete clinical-trials update and a quantified market/revenue projection cannot be produced.

FAQs

1. What is METHADOSE’s current FDA approval status and application type (NDA vs ANDA)?
2. Are there any active ClinicalTrials.gov studies involving methadone oral solution products under the METHADOSE brand?
3. What Orange Book patents (if any) are listed for METHADOSE, and when do they expire?
4. How often are methadone oral solution prescriptions substituted at the pharmacy level, and how does that affect brand volumes?
5. What is the typical competitive landscape for methadone hydrochloride oral solutions used in opioid use disorder programs?

References

No sources were provided in the input.