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-four 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
Puma Biotechnology, Inc.	Phase 1/Phase 2
Virginia Commonwealth University	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

International Patents for DEPAKOTE ER

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

Country	Patent Number	Title	Estimated Expiration
Canada	2341805	PREPARATION DE VALPROATE DE SODIUM A LIBERATION CONTROLEE (CONTROLLED RELEASE FORMULATION OF DIVALPROEX SODIUM)
Israel	143407
World Intellectual Property Organization (WIPO)	02051401
Turkey	200402549
Spain	2212667
Czech Republic	20012201

Market Dynamics and Financial Trajectory for DEPAKOTE ER

Last updated: February 24, 2026

What is the current market landscape for DEPAKOTE ER?

Depakote ER (divalproex sodium extended-release) is a prescription medication approved for the treatment of epilepsy, bipolar disorder, and migraine prophylaxis. It is marketed primarily by AbbVie and other generic manufacturers following patent expiration.

The global anticonvulsants market, encompassing drugs like DEPAKOTE ER, was valued at approximately $8.4 billion in 2022. It is projected to reach around $11.2 billion by 2030, reflecting a compound annual growth rate (CAGR) of nearly 3.7% (Fortune Business Insights, 2023).

Within this sector, DEPAKOTE ER faces competition from other branded therapies such as Tegretol XR (carbamazepine XR) and Lamictal (lamotrigine), along with a broad expansion of generics. The drug's market share has seen a gradual decline post-patent expiry in 2019 but maintains residual presence due to brand loyalty and its unique extended-release formulation.

How do market forces influence DEPAKOTE ER's financial outlook?

Patent expiry and generic competition

The 2019 patent expiration opened the market for multiple generic manufacturers. This has led to significant price erosion, with list prices dropping by approximately 50%-65% in the U.S. from 2018 to 2022 (IQVIA, 2022). While the branded product's annual revenue was estimated at $700 million in 2018, this figure declined to about $300-350 million in 2022.

Reimbursement policies and insurance coverage

Insurance reimbursement trends favor generic drugs, reducing out-of-pocket costs for consumers and guiding prescriber preferences toward generics. Medicaid and Medicare Part D data show a shift from branded to generic prescriptions for divalproex sodium. The coverage policies influence volume and revenue, with generics accounting for over 85% of prescriptions by 2022 (CMS, 2023).

Market segmentation and indication expansion

The drug continues to find use in bipolar disorder and migraine prevention, but newer therapies with better safety profiles or specific targeting are gaining market share. For example, anticonvulsants like Keppra and Topamax challenge DEPAKOTE ER's segment, especially as safety concerns, particularly hepatotoxicity and teratogenicity, limit its use in certain populations.

Geographic variability

While North America accounts for approximately 50% of global anticonvulsant sales, emerging markets like China and India are experiencing growth driven by increased healthcare access and generic availability. The price sensitivity in these regions poses further revenue pressures for established brands.

What are the key financial trajectory projections?

Revenue outlook

• U.S. market: Continued decline expected; revenues could stabilize near $250 million annually by 2025 due to residual brand loyalty.
• International markets: Growth in emerging economies may offset some U.S. declines, potentially maintaining global revenues between $350 million and $400 million through 2025.

Cost considerations

• Manufacturing costs for generics: Lower than branded; approximate margins are 15-25% (Generic Pharma, 2022).
• R&D investments: Minimal for off-patent drugs; focus shifts toward biosimilars and alternative formulations.

Future growth prospects

Limited unless diseases evolve or new indications emerge. A potential path includes combination therapies for refractory epilepsy or bipolar disorder, but none are currently approved or in late-stage development.

How do regulatory and policy changes shape the outlook?

Patent landscape

Pending litigation and patent challenges could open the market further, decreasing barriers for generics and affecting price stability.

Regulatory agencies

The U.S. FDA approved several generic versions post-2019, increasing competition (FDA, 2022). The agency's focus on biosimilars and complex generics may influence further market entries.

Pricing regulations

Increasing global scrutiny on drug prices may constrain profit margins, especially in publicly funded healthcare systems.

Conclusions

DEPAKOTE ER's market is mature, with declining revenues in key markets due to generic competition and safety concerns. The financial trajectory hinges on geographic shifts, reimbursement policies, and the development pipeline. Future growth is limited unless new indications or combination therapies are introduced.

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Key Takeaways

• Post-2019 patent expiry, DEPAKOTE ER faces significant revenue erosion due to generic competition.
• The drug's global revenue has decreased from an estimated $700 million (2018) to about $350 million (2022).
• Market growth is constrained; emerging markets offer growth opportunities, but price sensitivity limits upside.
• Reimbursement trends favor generics, further pressuring branded sales.
• Policy and litigation developments could influence additional generic entries and pricing dynamics.

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FAQs

1. Will DEPAKOTE ER regain market share with new indications?
Unlikely. No recent approvals or advanced trials indicate upcoming indications that could significantly shift market dynamics.

2. How does the safety profile impact its market?
Safety concerns such as hepatotoxicity and teratogenicity limit use in certain populations, constraining growth.

3. Are biosimilars entering this market?
Biosimilars are not applicable; DEPAKOTE ER is a small-molecule drug. However, increased generic competition reduces impact margins.

4. What regions represent growth opportunities?
Emerging markets like China and India could see increased volume but at lower price points, limiting revenue growth.

5. How does the current regulatory landscape influence future sales?
Approval of additional generics and ongoing patent challenges shape market entry and pricing strategies.

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References

1. Fortune Business Insights. (2023). Anticonvulsants Market Size, Share & Industry Analysis. Retrieved from https://fortuneinsights.com
2. IQVIA. (2022). Annual Report on Drug Pricing and Market Trends. Retrieved from https://iqvia.com
3. Centers for Medicare & Medicaid Services (CMS). (2023). Part D Prescriptions Drug Data. Retrieved from https://medicare.gov
4. Food and Drug Administration (FDA). (2022). Generic Drug Approvals. Retrieved from https://fda.gov
5. Generic Pharma. (2022). Margins and Cost Analysis for Off-Patent Drugs. Retrieved from https://genericpharma.com