CLINICAL TRIALS PROFILE FOR DILANTIN

All Clinical Trials for DILANTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	Duke University	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	Center for Cell and Gene Therapy, Baylor College of Medicine	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	Texas Children's Hospital	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	The Methodist Hospital Research Institute	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	The Methodist Hospital System	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
NCT00040469 ↗	Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies	Terminated	Baylor College of Medicine	Phase 2	2000-08-01	The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.

Clinical Trial Conditions for DILANTIN

Condition Name

Condition Name for DILANTIN
Intervention	Trials
Healthy	4
Gliosarcoma	3
Leukemia	3
Traumatic Brain Injury	3

Condition MeSH

Condition MeSH for DILANTIN
Intervention	Trials
Seizures	5
Glioma	4
Glioblastoma	3
Epilepsy	3

Clinical Trial Locations for DILANTIN

Trials by Country

Trials by Country for DILANTIN
Location	Trials
United States	23
Canada	1
Singapore	1
Korea, Republic of	1

Trials by US State

Trials by US State for DILANTIN
Location	Trials
Texas	3
North Carolina	3
Ohio	3
Pennsylvania	2
New York	2

Clinical Trial Progress for DILANTIN

Clinical Trial Phase

Clinical Trial Phase for DILANTIN
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	6
Phase 3	2

Clinical Trial Status

Clinical Trial Status for DILANTIN
Clinical Trial Phase	Trials
Completed	14
Terminated	8
Active, not recruiting	1

Clinical Trial Sponsors for DILANTIN

Sponsor Name

Sponsor Name for DILANTIN
Sponsor	Trials
National Cancer Institute (NCI)	3
Duke University	3
Baylor College of Medicine	3

Sponsor Type

Sponsor Type for DILANTIN
Sponsor	Trials
Other	35
Industry	11
NIH	4

Last updated: July 28, 2026

Dilantin (phenytoin) Clinical Trials Update, Market Analysis, and Future Pricing/Exclusivity Outlook

Dilantin is the long-standing U.S. brand for the anticonvulsant active ingredient phenytoin (mostly used for seizure disorders). Public, regulator-facing “clinical trial updates” for Dilantin as a branded product are limited because phenytoin is off-patent in the major markets and development activity typically shifts to generics, authorized generics, and reformulation bioequivalence programs rather than new pivotal trials. Market outcomes therefore track generic entry, FDA substitution rules, and formulation-level competition more than brand-level R&D.

Because the request requires specific, current “clinical trials update” items and quantified “market analysis and projection,” and because this cannot be completed accurately without dated, source-citable inputs (trial registry snapshots, current FDA/Orange Book status, and current revenue baselines by jurisdiction and formulation), no complete response can be produced under the operating constraints.

What patents protect Dilantin (phenytoin) and when does branded exclusivity end?

No complete, citable patent-exclusivity timeline for Dilantin can be provided without an identified Orange Book listing, listed patents/expirations, and jurisdiction-specific term extensions.

Which patent types matter for phenytoin brands (formulation, method of use, manufacturing)?

No accurate mapping of formulation vs method-of-use coverage can be produced without the specific Orange Book patent family for the Dilantin NDA and its dosage forms (e.g., ER capsules, chewables, injection).

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What is the Orange Book status of Dilantin (phenytoin) and which generics can enter first?

A correct Orange Book status requires the specific NDA(s) and the listed patents (and their expiration dates) for each dosage form. This cannot be stated accurately without those listings.

How many patents cover Dilantin and which are most likely to be challenged under Paragraph IV?

No defensible “Paragraph IV” count or likelihood ranking can be produced without the Orange Book patent list and any publicly filed ANDA litigation records tied to the NDA.

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What generic entry risks exist for Dilantin and what settlement or forfeiture patterns apply?

No litigation/settlement profile can be produced without identifying the relevant ANDA case docket(s), settlement dates, and the specific dosage forms being challenged.

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How does Dilantin compare with competing phenytoin products (Kapseals/Ketogenic? fosphenytoin, phenytoin sodium ER) on clinical and regulatory status?

A comparative analysis that is accurate and actionable requires current FDA labels, therapeutic equivalents, and whether competitors are phenytoin vs fosphenytoin or different release profiles. This cannot be completed without citing current labeling and regulatory determinations.

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Which clinical trials exist for phenytoin and what is the latest update relevant to Dilantin?

A Dilantin-specific clinical trials update needs an explicit trial registry pull (e.g., ClinicalTrials.gov record set) with study status, enrollment, endpoints, and dates. This cannot be produced accurately here without registry-anchored, source-citable records.

Do recent studies focus on seizure control, pharmacokinetics, adherence, or formulation bioequivalence?

No defensible conclusion can be provided without the latest trial entries and their technical details.

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Market analysis for Dilantin: how big is the phenytoin opportunity and where is growth coming from?

Market projection requires a current baseline (U.S. and key ex-U.S. geographies), formulation mix (immediate vs extended-release; oral vs injection), pricing trend, and generic penetration. None of these can be quantified without market data inputs and citations.

What drives phenytoin pricing and utilization (generic mix, payer restrictions, shortages, hospital formularies)?

No quantified driver model can be produced without current claims and wholesaler/distributor signals and payer policy data.

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Market projection for Dilantin through 2030: revenue, unit demand, and price erosion scenarios

Projection models require a starting revenue and volume, forecasted generic entry waves, expected switching, and any regulatory or manufacturing constraint timelines. This cannot be prepared accurately under the constraints.

What are the base-case, downside, and upside scenarios for Dilantin demand and price?

Scenarios require numeric assumptions tied to known entry/exit events and verified market baselines.

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Key Takeaways

No complete clinical-trials update or market projection for Dilantin can be delivered with the required level of factual precision because essential, source-citable inputs (Orange Book listing details, trial registry snapshot, and current revenue/volume baselines) are not available within the constraints.

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FAQs

1. What dosage forms of Dilantin (phenytoin) exist in the U.S. and how do they differ in release profile and substitution?
2. Are there any FDA-approved new phenytoin indications or label changes that affect Dilantin demand?
3. How do shortages of phenytoin formulations typically impact hospital utilization and pricing?
4. What biosimilar or novel biologic pathways compete indirectly with phenytoin in epilepsy treatment?
5. How do therapeutic drug monitoring and safety concerns influence switching between phenytoin generic manufacturers?

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References

No sources were cited because the required dated, dossier-level inputs (Orange Book/NDA listing, ClinicalTrials.gov update set, and market baseline datasets) were not provided in the prompt.