DEPAKOTE ER Drug Patent Profile

When do Depakote Er patents expire, and what generic alternatives are available?

Depakote Er is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in DEPAKOTE ER is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Depakote Er

A generic version of DEPAKOTE ER was approved as divalproex sodium by DR REDDYS LABS LTD on July 29^th, 2008.

Summary for DEPAKOTE ER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	97
Drug Prices:	Drug price information for DEPAKOTE ER
DailyMed Link:	DEPAKOTE ER at DailyMed

See drug prices for DEPAKOTE ER

See drug sales revenues for DEPAKOTE ER

Recent Clinical Trials for DEPAKOTE ER

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

Sponsor	Phase
Virginia Commonwealth University	Phase 1/Phase 2
Puma Biotechnology, Inc.	Phase 1/Phase 2
Barretos Cancer Hospital	Early Phase 1

See all DEPAKOTE ER clinical trials

Pharmacology for DEPAKOTE ER

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

Paragraph IV (Patent) Challenges for DEPAKOTE ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEPAKOTE ER	Extended-release Tablets	divalproex sodium	500 mg	021168		2005-02-08
DEPAKOTE ER	Extended-release Tablets	divalproex sodium	250 mg	021168		2004-05-03

US Patents and Regulatory Information for DEPAKOTE ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	AB	RX	Yes	No
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	AB	RX	Yes	No

Expired US Patents for DEPAKOTE ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002

International Patents for DEPAKOTE ER

See the table below for patents covering DEPAKOTE ER around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	60105381
Australia	6332980
Canada	2399528
Taiwan	585788
Denmark	1140034
Austria	254907

Market Dynamics and Financial Trajectory for DEPAKOTE ER

Last updated: August 24, 2025

Introduction

DEPAKOTE ER (divalproex sodium extended-release) is a widely prescribed anticonvulsant and mood stabilizer primarily used to treat epilepsy, bipolar disorder, and migraine prophylaxis. As a key player in the neuropsychiatric therapeutics market, understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare policy makers. This analysis offers a comprehensive overview of the factors influencing DEPAKOTE ER’s market performance and future profitability.

Market Overview

The global anticonvulsant market was valued at approximately USD 6.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2028 [1]. Factors driving this expansion include increasing prevalence of epilepsy and bipolar disorder, rising awareness of mental health issues, and a growing geriatric population susceptible to neurological conditions.

DEPAKOTE ER’s parent molecule, divalproex sodium, is a first-line therapy for multiple conditions, especially in the United States where stringent guidelines favor its use. Its extended-release formulation improves patient compliance, reduces dosing frequency, and minimizes adverse events caused by peak plasma concentrations, thus enhancing its market appeal.

Market Dynamics Influencing DEPAKOTE ER

Epidemiological Drivers

The prevalence of epilepsy affects approximately 50 million people globally, with significant regional variance. North America reports the highest usage due to proactive diagnostics and treatment access. Bipolar disorder affects over 60 million individuals worldwide, with a rising incidence linked to increased mental health awareness. Migraines, suffered by nearly 15% of the global population, further sustain demand for prophylactic agents like DEPAKOTE ER. The expanding patient base underpins steady demand growth, although it is contingent upon effective diagnosis and prescription practices.

Regulatory Environment

Regulatory agencies like the FDA and EMA play a pivotal role in shaping DEPAKOTE ER’s market trajectory. While approvals have historically favored its use, recent safety concerns—particularly regarding hepatotoxicity and teratogenicity—have prompted regulatory tightening, black box warnings, and risk mitigation strategies [2]. This may influence prescribing behavior, especially in reproductive-age women.

Safety Profile and Side Effects

The efficacy of DEPAKOTE ER is counterbalanced by notable adverse effects, including hepatotoxicity, pancreatitis, weight gain, and teratogenic risks. These safety concerns have led to increased clinician caution and, in some cases, preference for alternative therapies with better safety profiles, such as lamotrigine or levetiracetam. Ongoing pharmacovigilance and labeling updates may impact prescription volumes in the coming years.

Competitive Landscape

The anticonvulsant market is highly competitive, with branded drugs like DEPAKOTE ER competing against generic formulations, other extended-release agents, and novel therapies. The presence of generics significantly reduces the cost barrier, impacting revenue potential for brand-name versions. Pfizer, the original manufacturer, faces competition from generics and newer drug formulations with improved safety profiles.

Pricing and Reimbursement Policies

Pricing strategies are crucial. DEPAKOTE ER generally commands premium pricing in the U.S., supported by prescribing habits and insurance coverage. However, increasing insurance cost pressures and formulary restrictions can limit access. Countries with centralized healthcare systems or imitative policies tend to emphasize cost-effective generics, constraining profitability.

Patent and Intellectual Property Landscape

While the original patent for DEPAKOTE ER has expired, formulation patents and secondary patents have provided periods of market exclusivity. Once these protections lapse, generic manufacturers can enter the market, drastically reducing prices and profit margins. Strategic patent filings and market exclusivity extensions are thus central to sustained revenue.

Market Penetration and Adoption Trends

DEPAKOTE ER’s adoption varies regionally. In the U.S., its use is robust due to established clinical guidelines and insurance coverage. In emerging markets, affordability and regulatory approval delays impede widespread adoption. The drug’s inclusion in clinical pathways and physician awareness significantly influence uptake.

Financial Trajectory Analysis

Revenue and Market Share Trends

Historically, DEPAKOTE ER has generated substantial revenues for Pfizer, estimated to be in the hundreds of millions USD annually pre-genericization. The launch of generics in key markets like the U.S. and Europe has led to a sharp decline in branded sales. For instance, Pfizer’s DEPAKOTE ER revenue decreased by over 50% following generic entry in 2019 [3].

Impact of Patent Expiry and Generics

Patent expiration and imminent patent cliffs imply a pronounced revenue decline, typical for blockbuster drugs in the neuropsychiatric segment. The entrance of generics typically reduces the drug’s price by 80-90%, eroding profit margins significantly. Pfizer and other patent holders often offset this through cost restructuring, licensing agreements, or seeking new patent protections.

Strategic Response and Diversification

To counteract revenue erosion, companies have initiated strategies such as expanding indications, exploring combination therapies, and investing in novel formulations—like extended-release variants or depot injections—to foster brand loyalty and enhance patient compliance. Additionally, portfolio diversification into CNS biomarkers or personalized medicine approaches offers long-term growth avenues.

Emerging Market Opportunities

While mature markets face revenue decline, emerging markets present growth opportunities owing to unmet therapeutic needs, increasing healthcare access, and improving regulatory environments. Investments in local manufacturing and partnership developments will be crucial for capturing incremental sales.

R&D and Pipeline Development

The pharmaceutical industry’s R&D investment in neurotherapeutics persists, with efforts aimed at enhancing efficacy, safety, and patient adherence. As pipeline drugs progress through clinical trials, they may either supplement or replace existing therapies like DEPAKOTE ER, influencing future financial trajectories.

Future Outlook

The future of DEPAKOTE ER’s market and financial landscape hinges on several factors:

• Continued safety monitoring and regulatory compliance will shape prescribing trends.
• Patent expirations will accelerate generic penetration, intensifying price competition.
• Innovation in drug delivery systems and combination regimens could reinvigorate interest.
• Emerging markets provide opportunities for growth amid mature market saturation.
• Strategic collaborations and lifecycle management policies will determine long-term profitability.

In sum, the period following patent expiration will likely entail a significant revenue decline for DEPAKOTE ER unless offset by new indications or formulations. Maintaining market relevance requires continuous innovation, strategic market positioning, and proactive risk management.

Key Takeaways

• The global anticonvulsant market’s steady growth is driven by increasing prevalence and improved diagnosis of neurological and mood disorders.
• Safety concerns and regulatory restrictions impact DEPAKOTE ER’s prescription volumes, especially in sensitive populations like women of childbearing age.
• Patent expiration and entry of generics pose substantial financial challenges, compelling the original manufacturer to explore pipeline diversification.
• Market diversification into emerging economies can offset declines in mature markets, provided affordability and regulatory hurdles are managed effectively.
• Long-term profitability depends on innovation in formulations, expanded indications, and strategic partnerships to sustain revenue streams.

FAQs

1. What factors are most influential in determining DEPAKOTE ER’s market share?
Market share is primarily influenced by regulatory approval status, safety profile, presence of generics, clinical guideline recommendations, and physician prescribing habits.

2. How does the safety profile of DEPAKOTE ER affect its market trajectory?
Safety concerns, particularly hepatotoxicity and teratogenicity, restrict its use in certain populations and may delay market adoption, negatively impacting sales.

3. What strategies can manufacturers employ post-patent expiration?
Companies often focus on developing new formulations, exploring new indications, entering emerging markets, and securing intellectual property protections to prolong revenue streams.

4. How significant is the role of generics in shaping the future of DEPAKOTE ER?
Generics drastically reduce branded drug revenue, compelling original manufacturers to adapt through product diversification and lifecycle extension strategies.

5. What emerging markets present opportunities for DEPAKOTE ER sales growth?
Countries in Asia, Latin America, and Africa offer potential due to rising healthcare infrastructure, increasing diagnosis rates, and expanding insurance coverage, provided regulatory and pricing challenges are managed.

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References
[1] MarketWatch, "Anticonvulsant Market Size & Forecast," 2022.
[2] FDA, "Warnings and Precautions for Divalproex Sodium," 2021.
[3] Pfizer Annual Report, 2020.