CLINICAL TRIALS PROFILE FOR DELTASONE

505(b)(2) Clinical Trials for DELTASONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	National Cancer Institute (NCI)	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Texas Children's Hospital	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Baylor College of Medicine	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.

All Clinical Trials for DELTASONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002618 ↗	Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002618 ↗	Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma	Completed	Children's Oncology Group	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00003389 ↗	Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.

Clinical Trial Conditions for DELTASONE

Condition Name

Condition Name for DELTASONE
Intervention	Trials
Lymphoma	15
Acute Lymphoblastic Leukemia	15
Leukemia	13

Condition MeSH

Condition MeSH for DELTASONE
Intervention	Trials
Lymphoma	60
Prostatic Neoplasms	40
Leukemia	39

Clinical Trial Locations for DELTASONE

Trials by Country

Trials by Country for DELTASONE
Location	Trials
Canada	102
Australia	36
New Zealand	14
Puerto Rico	10
Switzerland	9

Trials by US State

Trials by US State for DELTASONE
Location	Trials
Texas	66
California	58
New York	53
Illinois	48
Ohio	45

Clinical Trial Progress for DELTASONE

Clinical Trial Phase

Clinical Trial Phase for DELTASONE
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	31
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for DELTASONE
Clinical Trial Phase	Trials
Completed	48
Recruiting	46
Active, not recruiting	32

Clinical Trial Sponsors for DELTASONE

Sponsor Name

Sponsor Name for DELTASONE
Sponsor	Trials
National Cancer Institute (NCI)	99
M.D. Anderson Cancer Center	24
Children's Oncology Group	12

Sponsor Type

Sponsor Type for DELTASONE
Sponsor	Trials
Other	156
NIH	103
Industry	79

Deltasone (Prednisone) Clinical Trials Update, Market Analysis, and Exclusivity/Patent-Driven Generic Outlook

Last updated: July 27, 2026

Deltasone is a brand of prednisone, a systemic corticosteroid with a long-established FDA profile and mature global generic competition. No actionable, drug-specific clinical-trial pipeline or branded-market projection can be produced from the information provided here because “Deltasone” is a brand name that maps to a widely marketed active ingredient and multiple label variations across markets.

Clinical trials update for Deltasone (prednisone): what studies are ongoing and recruiting?

No drug-specific, current clinical trials dataset for “Deltasone” is provided in the prompt. Prednisone has extensive historical trial coverage, but without a dated query scope (source, cutoff, registries, and specific formulation/indication link to “Deltasone”), a compliant update cannot be constructed.

Which prednisone trials typically appear for systemic corticosteroids?

Common prednisone study categories (historically and across registries) include:

• COVID-19 and other inflammatory respiratory indications
• Autoimmune flares and corticosteroid-sparing strategies
• Pediatric dosing regimens and tapering schedules
• Comparative trials versus alternative steroids or biologic regimens

A Deltasone-specific status list cannot be generated from the prompt.

Market analysis for Deltasone (prednisone): how big is the revenue opportunity and who sells it?

Deltasone’s commercial performance is not determinable from the prompt. Prednisone is widely genericized globally, and “brand revenue” depends on:

• US and ex-US pricing and rebate structure
• payer mix and channel stocking
• label positioning versus other steroid brands
• generic penetration intensity by strength/formulation

A market sizing and share forecast for the Deltasone brand cannot be produced without brand-level sales data, country coverage, and the exact formulation(s) in scope.

What does the prednisone market structure look like in practice?

• The active ingredient is mass-generic in the US and most major markets.
• Brand share typically compresses quickly after generic entry.
• Competitive dynamics are driven by NDC-specific supply, pricing, and manufacturing continuity rather than clinical differentiation.

No Deltasone-specific commercial metrics are provided.

When does Deltasone (prednisone) lose exclusivity: Orange Book status, patents, and exclusivity windows?

No Orange Book listings, patent numbers, or exclusivity identifiers are provided. Prednisone is an off-patent, legacy small molecule in most jurisdictions; determining whether any residual, formulation-specific, method-of-use, or packaging patents exist for “Deltasone” requires the specific FDA application/NDA/BLA mapping and NDC.

What patents could still matter for a legacy corticosteroid brand?

For corticosteroid brands, remaining value usually comes from one of these buckets:

• formulation/process patents tied to specific strengths or dosage forms
• method-of-use patents tied to a particular label expansion
• secondary patents covering manufacturing steps or polymorph/crystal forms (less common for prednisone tablets)
• pediatric exclusivity or other regulatory exclusivities (only if tied to a qualifying NDA and timeframe)

Without an Orange Book record for “Deltasone,” the exclusivity answer cannot be produced.

What generic entry risks exist for Deltasone (prednisone) and how do Paragraph IV challenges apply?

No Paragraph IV litigation or ANDA filing history is supplied. Prednisone’s age suggests extensive generic availability, but a credible “entry risks” analysis requires:

• ANDA counts by strength/formulation
• any pending or settled Paragraph IV cases
• FDA approval dates and litigation stay periods
• whether Deltasone is protected by any relevant unexpired Orange Book listed patents for the relevant dosage forms

None of this is in the prompt.

How does Deltasone compare with other prednisone brands and generics on access, pricing, and label coverage?

Deltasone-to-competitor comparisons require:

• branded competitor list (brand prednisone, liquid, taper packs, specialty kits)
• NDC-level coverage
• wholesale acquisition cost and net price by payer segment
• availability and backorder history
• therapeutically equivalent substitution rules and AB-rated status

The prompt provides no competitor set or country scope.

Biosimilar risk for Deltasone: does it face biologic pathway competition?

Prednisone is a small molecule. Biosimilars do not apply. Without a prompt mapping “Deltasone” to a biologic or combination product (not supported by standard usage), biosimilar risk is not a relevant category.

Patent strength for Deltasone: what patents protect prednisone brands?

No patent estate information, assignees, or jurisdictions are supplied. Without a list of Orange Book patents (US) and any corresponding EP/WO family members, no patent-strength assessment can be generated.

What patent datasets are typically required to evaluate a prednisone brand?

• US Orange Book (NDA, patent numbers, expiration dates, exclusivity codes)
• litigation docket (MDL/state/federal, case captions)
• global patent families (EP/WO/CA/AU/JP) and status per office
• regulatory exclusivity (pediatric, orphan, 505(b)(2) exclusivity if applicable)

None are provided.

Key Takeaways

• Deltasone is prednisone, a legacy systemic corticosteroid with extensive generic availability.
• The prompt lacks the drug-specific clinical-trial, FDA/Orange Book, patent, and brand sales inputs required to produce an evidence-based clinical update and market projection.
• No defensible exclusivity timeline, Paragraph IV risk, or patent-strength view can be produced for “Deltasone” from the information provided.

FAQs

1. Is Deltasone covered by the FDA Orange Book for patent protection, and when do listed patents expire?
2. Are there current Deltasone-specific clinical trials in ClinicalTrials.gov by indication and recruiting status?
3. How many ANDAs are approved for generic prednisone tablets/solutions for the same strengths and routes as Deltasone?
4. Does Deltasone have any formulation-specific patents (process, polymorph, packaging) affecting generic substitution?
5. What share and pricing differences exist between Deltasone and AB-rated generic prednisone in major US channels?

References

1. None.