VALPROATE SODIUM Drug Patent Profile

Which patents cover Valproate Sodium, and when can generic versions of Valproate Sodium launch?

Valproate Sodium is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Pharmobedient, and Sagent. and is included in four NDAs.

The generic ingredient in VALPROATE SODIUM is valproate sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Valproate Sodium

A generic version of VALPROATE SODIUM was approved as valproate sodium by SAGENT on November 14^th, 2002.

Summary for VALPROATE SODIUM

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	67
Patent Applications:	6,274
DailyMed Link:	VALPROATE SODIUM at DailyMed

Recent Clinical Trials for VALPROATE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Desitin Arzneimittel GmbH	PHASE1
BioPharma Services Inc.	PHASE1

See all VALPROATE SODIUM clinical trials

Pharmacology for VALPROATE SODIUM

Drug Class	Anti-epileptic Agent Mood Stabilizer
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for VALPROATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	076539-001	Jun 26, 2003	AP	RX	No	No
Sagent	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	076295-001	Nov 14, 2002	AP	RX	No	No
Hikma Farmaceutica	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	078523-001	Feb 17, 2010	AP	RX	No	Yes
Pharmobedient	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	208120-001	Dec 22, 2021		DISCN	No	No

Valproate Sodium Market Dynamics, Financial Trajectory, Patents, and Generic Competition

Last updated: September 8, 2026

Valproate sodium is a mature, low-cost generic antiseizure medicine used primarily in hospitals and specialty settings. Its commercial value comes from recurring demand for injectable therapy, established clinical use, and manufacturing scale rather than patent exclusivity. The market has limited growth potential, high price pressure, and exposure to supply interruptions, regulatory controls, and safety restrictions related to hepatotoxicity, pancreatitis, teratogenicity, and neurodevelopmental risk.

What is the current market position of valproate sodium?

Valproate sodium is the intravenous salt form of valproic acid. In the United States, it is used when oral administration of valproate products is temporarily unavailable or impractical. It is not interchangeable in every clinical setting with divalproex sodium, which is an oral formulation that dissociates into valproate in the gastrointestinal tract.

Market attribute	Valproate sodium assessment
Primary dosage form	Intravenous injection
Therapeutic class	Antiseizure medication
Main clinical uses	Complex partial seizures, absence seizures, mixed seizure disorders, and status epilepticus-related hospital use
Commercial status	Generic, mature product
Originator product	Depacon, historically marketed by Abbott/AbbVie
Patent relevance	No meaningful remaining composition-of-matter exclusivity
Main buyers	Hospitals, health systems, wholesalers, group purchasing organizations
Main competitors	Generic valproate sodium injection, oral valproic acid, divalproex sodium, levetiracetam, fosphenytoin, lacosamide
Commercial growth driver	Hospital utilization and supply reliability
Main risks	Safety restrictions, procurement price erosion, shortages, manufacturing concentration

The product is a small segment of the broader valproate market. Oral valproic acid and divalproex sodium account for substantially more chronic-use demand because they are prescribed for long-term outpatient treatment. Valproate sodium injection is more dependent on inpatient utilization.

How large is the valproate sodium market?

A reliable standalone global revenue figure for valproate sodium is not generally disclosed by manufacturers because the product is reported within broader generic injectables, antiseizure medicines, or hospital products. The market is best analyzed through prescription volume, hospital purchasing, supplier count, price trends, and channel demand.

The financial profile has four characteristics:

1. Unit prices are low relative to newer branded antiseizure medicines.
2. Chronic oral demand is more stable than injectable demand.
3. Hospital contracting compresses gross margins.
4. Shortages can temporarily increase prices and supplier revenue without improving long-term market economics.

The injectable market is smaller than the combined oral valproate market but can carry higher operational complexity. Sterile manufacturing, injectable quality controls, container-closure requirements, and hospital supply contracts create higher barriers than tablet production. These barriers can support pricing during supply disruptions, but they do not recreate patent-like exclusivity.

What drives demand for valproate sodium?

Demand is tied to:

• Hospital admissions involving epilepsy or seizure control.
• Emergency and intensive-care use.
• Temporary substitution when oral administration is not possible.
• Existing treatment protocols that include intravenous valproate.
• Continued use in patients who are clinically stable on valproate therapy.
• Limited access to or intolerance of alternative antiseizure medicines.

Demand is constrained by the availability of levetiracetam and other alternatives, increasing clinical scrutiny of fetal and developmental risks, and physician preference for drugs with simpler monitoring profiles.

When did valproate sodium lose exclusivity?

Valproate sodium has been off-patent for many years. The historical originator product, Depacon, did not retain a current composition-of-matter barrier that could prevent generic competition. FDA approval of generic valproate sodium injection established a multi-supplier market under the abbreviated new drug application pathway.

Exclusivity category	Current position
Composition-of-matter patent	Expired or commercially irrelevant
Original product exclusivity	Expired
Formulation exclusivity	Expired for the established injectable product
Pediatric exclusivity	No current commercial effect
Orphan exclusivity	Not a material barrier for the standard product
Biosimilar exclusivity	Not applicable
Generic exclusivity	Any product-specific period would be historical rather than a current market barrier

The commercial question is therefore not when a patent expires. It is whether a supplier can maintain FDA-compliant sterile production at a price that supports continued participation.

What patents protect valproate sodium?

No active patent estate is known to provide broad market protection for the established valproate sodium injectable product. Historical patents associated with valproate products may have covered specific formulations, dosing approaches, delivery systems, or combinations, but they do not create a broad barrier to generic valproate sodium injection.

What formulation patents remain relevant?

Potentially relevant intellectual property can include:

• Low-concentration or ready-to-use injectable solutions.
• Container and vial systems.
• Stability-enhancing excipients.
• Premixed infusion bags.
• Extended-release oral formulations.
• Fixed-dose combinations.
• Specific administration protocols.

These rights would protect a particular presentation or method, not the active pharmaceutical ingredient generally. A generic manufacturer can often avoid such patents by using a different concentration, container, excipient system, or administration method, subject to FDA requirements and applicable patent certifications.

What method-of-use patents affect valproate sodium?

Method-of-use rights may address seizure syndromes, migraine prevention, bipolar disorder, dosing schedules, or patient populations. Their commercial importance is limited where the core product is already prescribed for multiple established indications and the generic label does not need to include a patented use.

Valproate products also face an unusual regulatory constraint: safety information can restrict prescribing even when no patent prevents use. The FDA label carries boxed warnings for hepatotoxicity and fetal risk, and the label includes warnings concerning pancreatitis, thrombocytopenia, hyperammonemia, and fetal neurodevelopmental harm. [1]

What is the FDA regulatory status of valproate sodium?

FDA-approved valproate sodium injection is an established generic prescription product. The principal regulatory obligations involve quality, sterile manufacturing, labeling, pharmacokinetics, and pharmacovigilance.

The FDA-approved label identifies intravenous valproate sodium as a substitute for oral valproate products when oral administration is temporarily not feasible. The label states that intravenous dosing should use the same total daily dose and frequency as the oral product when replacing oral therapy, subject to clinical judgment and product-specific instructions. [1]

The safety profile materially affects market use:

• Hepatotoxicity can be fatal, particularly in young children and patients with certain metabolic or mitochondrial disorders.
• Valproate exposure during pregnancy is associated with major congenital malformations and adverse neurodevelopmental outcomes.
• Pancreatitis and hyperammonemia are recognized serious risks.
• Platelet reduction and coagulation abnormalities can affect surgical and inpatient use.
• Drug interactions require monitoring, particularly with other antiseizure medicines.

FDA labeling and professional guidance have reduced use in some women of childbearing potential and in pregnancy. The European Medicines Agency and national regulators have imposed additional pregnancy-prevention measures for valproate-containing medicines. [2]

What is the Orange Book status of valproate sodium?

The FDA Orange Book identifies approved drug products and patent information submitted by applicants. For a mature generic such as valproate sodium injection, Orange Book analysis is primarily useful for confirming approved applicants, dosage forms, and any listed patents or exclusivity entries. [3]

The product’s commercial structure is consistent with a standard generic market:

• Multiple abbreviated new drug application holders may compete.
• Listed patents, if any, are unlikely to create broad protection over the active ingredient.
• Paragraph IV litigation is not the principal entry risk.
• Supplier approval and manufacturing capacity matter more than patent clearance.

Which companies compete in valproate sodium?

Competition varies by country and over time because suppliers enter and leave sterile injectable markets. The U.S. market has historically included generic injectable manufacturers and specialty hospital suppliers such as Hikma Pharmaceuticals and other FDA-approved ANDA holders. The former Depacon brand was associated with Abbott Laboratories and later AbbVie.

A supplier’s ability to compete depends on:

• FDA inspection history.
• Access to validated sterile manufacturing lines.
• Reliable active pharmaceutical ingredient supply.
• Hospital contract coverage.
• Wholesaler inventory.
• Ability to absorb low prices during competitive tenders.
• Capacity to respond to shortages.

The market is more concentrated operationally than the number of approved products suggests. Several approved suppliers may not actively commercialize product at all times.

What is the financial trajectory for valproate sodium?

Valproate sodium has a mature-to-declining financial trajectory in nominal terms, interrupted by short-term price and volume changes.

Period	Financial pattern	Primary explanation
Originator period	Higher pricing and stronger margins	Brand positioning and limited competition
Initial generic entry	Rapid price erosion	Multiple ANDA suppliers
Mature generic period	Stable volume, low margins	Hospital tenders and substitution
Shortage periods	Temporary price increases	Reduced supplier availability
Long term	Flat or declining value	Aging product, safety constraints, alternative therapies

Revenue exposure is concentrated in products rather than in the active ingredient itself. Companies with broad injectable portfolios can treat valproate sodium as a portfolio-fill product that supports hospital relationships. A single-product supplier faces greater risk because low prices leave little room to absorb manufacturing deviations, recalls, or freight costs.

What affects manufacturer profitability?

The largest cost factors are:

• Sterile fill-finish operations.
• Quality-control testing.
• Regulatory compliance.
• Vial, stopper, and packaging costs.
• Inventory requirements for hospital service levels.
• Contracting discounts.
• Product liability and pharmacovigilance obligations.
• API procurement and validation.

Margins can fall sharply when a competitor re-enters the market. Conversely, a manufacturing interruption can produce temporary pricing power, but that benefit may be offset by remediation costs and regulatory scrutiny.

Is there biosimilar risk for valproate sodium?

No. Valproate sodium is a small-molecule chemical drug, not a biologic. Biosimilar competition does not apply. Competition occurs through generic drug applications, formulation alternatives, therapeutic substitution, and hospital procurement.

The relevant competitive threats are:

• Generic valproate sodium injection.
• Oral valproic acid and divalproex sodium.
• Levetiracetam injection and tablets.
• Fosphenytoin and phenytoin.
• Lacosamide.
• Brivaracetam and other newer antiseizure medicines.

Levetiracetam is especially important in hospital settings because it has intravenous and oral presentations, broad use in acute seizure management, and a safety profile that is often viewed as easier to manage than valproate in selected patients.

What generic entry risks exist for valproate sodium?

The market has limited Paragraph IV risk because the principal patents are expired or not commercially decisive. Generic-entry risk instead concerns further price competition and the re-entry of previously inactive suppliers.

What could trigger a generic price decline?

A substantial price decline could follow:

• Approval of a new ANDA holder.
• Re-entry by a supplier after manufacturing remediation.
• Expansion of an existing supplier’s production capacity.
• A hospital contract rebid.
• Increased availability of alternative injectable antiseizure medicines.
• A shift from branded or shortage-priced supply to normal generic competition.

What could cause a price increase?

Prices may rise temporarily if:

• A major sterile facility experiences a shutdown.
• An API supplier fails.
• FDA quality actions remove a supplier from the market.
• Demand increases during a hospitalization or seizure-care surge.
• Wholesaler inventories fall below hospital requirements.

These events affect transaction price and availability more than long-term market size.

What patent litigation and settlement agreements affect valproate sodium?

Patent litigation and settlement agreements are not the main commercial drivers for the established valproate sodium injectable market. The product’s key barriers are manufacturing and regulatory, not patent-based.

Historical disputes involving valproate-related products may have concerned extended-release formulations, branded divalproex products, or specific methods of treatment. Those disputes should not be treated as evidence of current exclusivity for basic valproate sodium injection.

A current market review should distinguish:

• Litigation over Depakote or other divalproex formulations.
• Litigation over oral extended-release products.
• Product-liability claims involving fetal exposure or other safety risks.
• ANDA litigation involving a particular formulation.
• Patent disputes involving the basic injectable salt.

These categories have different implications for market entry and should not be combined.

How does valproate sodium compare with competing antiseizure drugs?

Product	Main advantage	Main limitation	Commercial implication
Valproate sodium	Broad antiseizure activity and established hospital use	Teratogenicity, hepatotoxicity, monitoring burden	Low-cost mature product
Levetiracetam injection	Simple dosing and broad inpatient use	Neuropsychiatric adverse effects in some patients	Strong substitution pressure
Fosphenytoin	Established status epilepticus use	Cardiac and infusion-related concerns	Protocol-dependent demand
Lacosamide injection	Convenient option for selected seizure patients	Higher cost than mature generics	Premium or specialty positioning
Phenytoin injection	Long clinical history and low cost	Narrow therapeutic window and administration complexity	Legacy demand with substitution risk

Valproate retains clinical value because it treats multiple seizure types and remains familiar to neurologists and hospital physicians. Its safety profile limits use in certain patient groups and creates a continuing shift toward alternatives where clinical circumstances permit.

What is the geographic coverage of valproate sodium?

The product is marketed in multiple regions as valproate sodium, sodium valproate, valproic acid, or related formulations. Regulatory naming and approved indications differ by jurisdiction.

The United States market is shaped by:

• FDA ANDA approvals.
• Orange Book listings.
• Hospital group purchasing.
• FDA drug-shortage management.
• Controlled procurement of sterile injectables.

European markets are shaped by national reimbursement systems and pregnancy-prevention restrictions coordinated through European regulatory action. In many countries, oral sodium valproate has a larger commercial role than the injectable form.

Geographic commercial risk is highest where there are few sterile suppliers and public procurement depends on tenders. A manufacturing problem at one facility can affect several countries if the same site supplies multiple markets.

What is the outlook for valproate sodium?

The base case is stable-to-declining demand with periodic supply-driven volatility. The product is unlikely to generate significant organic growth absent a major change in hospital treatment protocols or a supply disruption affecting competing products.

Investment and licensing value is concentrated in:

• Reliable sterile manufacturing.
• Geographic supply rights.
• Hospital distribution access.
• Shortage-response capability.
• Formulation improvements that simplify administration.
• Contract manufacturing with validated injectable capacity.

Broad patent licensing has limited value because the active ingredient is generic. A differentiated formulation, ready-to-use presentation, or supply agreement may have greater commercial value than a license covering the active compound.

Key Takeaways

• Valproate sodium is a mature generic antiseizure medicine with limited patent-based value.
• Injectable demand is concentrated in hospitals and is smaller than the broader oral valproate market.
• The principal financial drivers are manufacturing reliability, hospital contracts, and generic price competition.
• FDA safety warnings, especially pregnancy-related risks, constrain prescribing and support substitution to alternatives.
• Biosimilar risk does not apply because valproate sodium is a small-molecule drug.
• Paragraph IV litigation is less important than sterile manufacturing capacity and supply continuity.
• Levetiracetam is a significant competitive alternative in inpatient seizure management.
• Revenue is likely to remain flat or decline over time, with temporary increases during supply disruptions.
• Formulation and manufacturing rights have more commercial relevance than basic compound patents.
• The strongest investment thesis is operational: dependable supply, regulatory compliance, and hospital distribution.

FAQs

Is valproate sodium the same as Depakote?

No. Depakote is a brand name primarily associated with divalproex sodium. Valproate sodium is an intravenous salt formulation, while Depakote products are oral formulations. They produce valproate exposure but are not identical dosage forms.

Does valproate sodium have pediatric exclusivity?

No current pediatric exclusivity is a material barrier to generic valproate sodium injection. Any historical exclusivity periods do not prevent current generic competition.

Can valproate sodium be substituted with levetiracetam?

Clinical substitution depends on seizure type, patient characteristics, prior response, organ function, pregnancy status, and physician judgment. The products are not automatically interchangeable under generic substitution rules.

Is valproate sodium a controlled substance?

Valproate sodium is not federally scheduled as a controlled substance in the United States. It remains a prescription medicine subject to safety monitoring and product-specific labeling requirements.

Does valproate sodium have a meaningful orphan-drug market?

No broad orphan-drug exclusivity market is associated with standard valproate sodium injection. Its use spans established seizure indications, and commercial demand comes from general hospital and neurological practice.

References

1. U.S. Food and Drug Administration. (2023). Valproate sodium injection, prescribing information. DailyMed. https://dailymed.nlm.nih.gov/

2. European Medicines Agency. (2018). Valproate and related substances: Pregnancy prevention programme. https://www.ema.europa.eu/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book