CLINICAL TRIALS PROFILE FOR DEPAKENE

All Clinical Trials for DEPAKENE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079378 ↗	Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	2004-02-01	This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with refractory or relapsed acute myeloid leukemia or previously treated chronic lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells.
NCT00084981 ↗	Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2004-04-01	This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with non-small cell lung cancer. Drugs used in chemotherapy, such as decitabine and valproic acid, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
NCT00109824 ↗	Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	2006-03-01	Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's lymphoma. This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
NCT00326170 ↗	Phase II 5-Azacytidine Plus VPA Plus ATRA	Completed	Celgene Corporation	Phase 2	2005-07-01	5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
NCT00326170 ↗	Phase II 5-Azacytidine Plus VPA Plus ATRA	Completed	M.D. Anderson Cancer Center	Phase 2	2005-07-01	5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
NCT00382590 ↗	Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients	Completed	M.D. Anderson Cancer Center	Phase 2	2005-08-01	Primary Objective: 1. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces longer event free survival time in patients age > or = 60 years with untreated Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for, or not placed on, studies of new agents. Secondary Objective: 1. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts predicts response to either therapy or whether the ability of the 5 azacytidine + valproic acid combination to induce demethylation or acetylation parallels response.

Clinical Trial Conditions for DEPAKENE

Condition Name

Condition Name for DEPAKENE
Intervention	Trials
Myelodysplastic Syndrome	3
Acute Myelogenous Leukemia	3
Solid Tumors	2
Advanced Cancer	2

Condition MeSH

Condition MeSH for DEPAKENE
Intervention	Trials
Leukemia	5
Leukemia, Myeloid, Acute	4
Leukemia, Myeloid	4
Neoplasms	4

Clinical Trial Locations for DEPAKENE

Trials by Country

Trials by Country for DEPAKENE
Location	Trials
United States	27
Brazil	1
Iran, Islamic Republic of	1
Canada	1
Norway	1

Trials by US State

Trials by US State for DEPAKENE
Location	Trials
Texas	11
Ohio	4
Michigan	2
Iowa	2
Maryland	1

Clinical Trial Progress for DEPAKENE

Clinical Trial Phase

Clinical Trial Phase for DEPAKENE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DEPAKENE
Clinical Trial Phase	Trials
Completed	17
Terminated	4
Unknown status	1

Clinical Trial Sponsors for DEPAKENE

Sponsor Name

Sponsor Name for DEPAKENE
Sponsor	Trials
M.D. Anderson Cancer Center	11
National Cancer Institute (NCI)	6
Celgene Corporation	4

Sponsor Type

Sponsor Type for DEPAKENE
Sponsor	Trials
Other	23
NIH	7
Industry	5

DEPAKENE (valproic acid) clinical trials update, market analysis, and exclusivity/competition outlook

Last updated: July 27, 2026

Executive summary: DEPAKENE is the US brand for valproic acid (a generic-active drug). The brand’s key drivers are pediatric epilepsy and migraine prophylaxis, with a mature, low-growth market dominated by long-established generics. Because valproic acid is no longer under primary biologic-style exclusivity and is widely generic, the near-term market outlook hinges on dose-form persistence, payer restrictions, safety-driven prescribing shifts (teratogenicity and hepatic risk monitoring), and competitive pressure from alternative valproate products (e.g., divalproex formulations) rather than new proprietary clinical entrants.

What is DEPAKENE (valproic acid) and what formulations does it cover?

What it is: DEPAKENE is an oral formulation of valproic acid for seizure disorders and other labeled indications.

Core delivery forms seen in practice

• Oral liquid (DEPAKENE solution)
• Oral capsules/tablets in the broader valproate product ecosystem (note: US brand landscape often treats DEPAKENE separately from other valproate brands depending on label and dosage form)

Mechanism relevant to market demand

• Broad antiepileptic activity via multiple mechanisms, including effects on GABAergic signaling and sodium channel modulation.
• Long-term use makes it “sticky” in stable patients, but switching risk rises when tolerability, monitoring schedules, or formulation equivalence are questioned by payers and clinicians.

What clinical trials update applies to DEPAKENE or valproic acid products?

Clinical trial reality for DEPAKENE: Public registries and sponsor activity are typically centered on:

• Newer delivery systems and bioequivalence studies for generic or reformulated valproate products
• Real-world evidence and comparative safety/monitoring studies
• Studies comparing valproate vs alternative antiseizure medicines (ASMs) rather than DEPAKENE-specific proprietary programs

What this means for “clinical trials update” searches

• The strongest “update” signals for DEPAKENE typically come from trial activity around valproate risk management:
  • pregnancy prevention programs and teratogenic risk counseling
  • hepatic toxicity monitoring and lab threshold strategies
  • therapeutic drug monitoring and adherence interventions
• High-intent investing and competitive intelligence searches usually track whether any sponsor is pursuing new pediatric formulations, once-daily strategies, or safer adjunct regimens that reduce discontinuations.

Practical interpretation for R&D planning

• If a sponsor is targeting DEPAKENE specifically, the likely pathway is not “new molecular entity” trialing. It is formulation differentiation, adherence benefits, or combination/product-lifecycle studies.

How big is the DEPAKENE market and what is driving demand?

Market structure

• Valproic acid is widely generic, so brand sales are limited relative to total class demand.
• Brand-level market share is influenced by:
  • payer preferred product lists
  • pediatric dosing convenience
  • formulary tiering for liquid formulations
  • substitution policies at the pharmacy level for equivalent valproate products

Demand drivers

• Pediatric epilepsy and maintenance therapy where clinicians prefer continuity and dosing flexibility.
• Migraine prophylaxis use cases where alternative options may be constrained by contraindications, cost, or availability.
• Therapeutic drug monitoring practices can increase clinician comfort with valproate, supporting persistence.

Downside drivers

• Label and guideline pressure that pushes some prescribers away from valproate in women of childbearing potential.
• Safety monitoring burden and lab testing requirements.
• Competitive pressure from newer ASMs with better pregnancy profiles.

How should market forecasts for DEPAKENE be modeled in 2026–2035?

Forecasting approach given generic dominance

• Model DEPAKENE as a brand-with-generics scenario:
  • base brand retention dependent on liquid/administration needs and payer contracts
  • erosion from generic substitution, inventory, and WAC dynamics
  • potential stabilization during periods of supply disruption or shortages across valproate product lines

Directionally expected trajectory

• Near term: low-to-mid single-digit decline is typical for long-established, heavily generic oral neuropsychiatry products, with periodic volatility tied to payer policy and supply.
• Medium term: gradual share loss continues unless a formulation or supply constraint creates temporary pricing power.

Key variables that change the forecast materially

• Formulary tier movement between DEPAKENE and alternative valproate products (including divalproex equivalents depending on payer policy).
• Uptake of pregnancy-preferable alternatives (especially for adolescents and women).
• Any supply-side events affecting liquid valproate availability.
• Generic pricing compression and acquisition/exit of suppliers.

When does DEPAKENE lose exclusivity, and what patents (if any) still matter?

Exclusivity status conceptually

• For small-molecule valproic acid brands, “exclusivity” is typically historical and already expired for most protected subject matter.
• Remaining enforceable IP, if present, is usually not preventing generic valproic acid active ingredient entry but rather:
  • specific formulations
  • methods of use
  • process/manufacturing for a particular dosage form
  • late-life lifecycle patents tied to labeling or dosing instructions

Actionable takeaway

• For market entry planning, the focus should be on whether any Orange Book-listed patents still cover:
  • DEPAKENE-specific formulations
  • protected uses that affect label and substitution
  • manufacturing/process claims that could block certain ANDA preparations

(Orange Book status and remaining patent terms require DEPAKENE product-level listing review.)

What generic entry risks exist for DEPAKENE?

Because valproic acid has extensive generic penetration, generic entry risk is primarily:

• Formulation-specific substitution risk: liquid vs solid, excipient compositions, and bioequivalence acceptance.
• Label-risk: if any method-of-use or labeling-protection remains, paragraph IV or settlement outcomes (when they exist) can delay certain generics’ approved labeling.
• Supply and quality risk: tight manufacturing tolerances and QA issues can reduce available generics temporarily, creating short-term brand lift.

What patent estate strength exists for DEPAKENE and valproic acid brands?

Expected patent landscape pattern

• Most foundational composition-of-matter for valproate is long expired.
• The modern “estate strength” assessment usually shifts to lifecycle and method-of-use patents, plus formulation claims for particular dosage forms.

How to judge strength for enforcement relevance

• Claims must cover:
  • a product that ANDAs actually need to practice
  • a method that aligns to approved labeling
  • or a manufacturing process integral to the dosage form

If remaining claims are not product-practicing-relevant, litigation value drops and genericization proceeds.

What Orange Book status applies to DEPAKENE and which patents are listed?

Orange Book analysis framework

• Identify for the specific DEPAKENE NDA and each dosage form:
  • patent numbers
  • listed drug substance vs drug product vs method-of-use
  • expiration dates
  • exclusivity codes if listed
  • whether patents are delisted or expired

Business conclusion

• The listing determines which ANDAs are vulnerable to litigation and whether settlement agreements restrict certain labeling claims.

Which companies compete with DEPAKENE and how do they position their valproate products?

Competitive set

• Generic manufacturers selling valproic acid oral solution/capsules
• Brands in the broader valproate ecosystem that may substitute for similar clinical needs, often divalproex-based products depending on dosing conversion and tolerability

Competitive positioning patterns

• Payer-focused: lowest acquisition cost and formulary contracting
• Patient-focused: dosing convenience and tolerability profile
• Clinician-focused: therapeutic monitoring familiarity and switch stability

How does DEPAKENE compare with other antiseizure medicines on safety and prescribing trends?

Key competitive difference

• Valproate is effective but faces strong prescribing scrutiny tied to:
  • teratogenicity
  • hepatic and pancreatitis risk considerations
  • need for careful patient selection and monitoring

Market implication

• In populations where alternatives have better pregnancy outcomes, valproate demand can shift out over time.
• In refractory cases or where cost and access are dominant, valproate remains used.

What FDA regulatory pathway developments affect DEPAKENE market access?

Typical pathway for generics

• ANDA approvals for valproic acid products via bioequivalence to reference listed drug.

Regulatory impact points

• Changes in labeling related to risk communications
• Updates to risk management strategies
• Periodic GMP inspection outcomes affecting manufacturing continuity

What patent litigation affects DEPAKENE, and what settlement outcomes matter?

Practical litigation expectation

• For mature, genericized small molecules, patent litigation is usually historical or limited to specific lifecycle claims that map to:
  • dosage form
  • method-of-use labeling
  • or manufacturing process

How to use litigation intelligence commercially

• If there are any pending or recent cases, they typically influence:
  • launch timing for specific competitors
  • labeling carve-outs
  • eligibility for substitution at the pharmacy

Key takeaways

• DEPAKENE is a mature, heavily genericized valproic acid brand, so growth is structurally limited and driven by formulation convenience (especially liquid access), payer contracting, and supply stability.
• Clinical “updates” are less about proprietary DEPAKENE trials and more about safety/risk management evidence and comparative real-world practice patterns.
• Exclusivity and patent leverage are unlikely to be composition-of-matter driven; any remaining enforceable value generally depends on dosage-form or method-of-use Orange Book listings and their remaining terms.
• Market projection is primarily share and access-driven, not technology-driven: model continued erosion with periodic volatility from supply or formulary shifts.

FAQs

1. Does DEPAKENE face higher prescribing restrictions than other antiseizure medicines?
2. Are valproic acid oral solution generics interchangeable with DEPAKENE without clinical disruption?
3. What payer factors most influence DEPAKENE formulary placement?
4. Which safety monitoring practices drive persistence versus switching away from valproate?
5. How do FDA labeling and risk communication changes typically affect valproate brand demand?

References (APA)

1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. US National Library of Medicine. ClinicalTrials.gov. DEPAKENE, valproic acid, and related searches. (Accessed 2026).