DEPAKOTE Drug Patent Profile

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

Depakote is a drug marketed by Abbvie and Abbott and is included in four NDAs.

The generic ingredient in DEPAKOTE 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

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

Summary for DEPAKOTE

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	97
Drug Prices:	Drug price information for DEPAKOTE
Drug Sales Revenues:	Drug sales revenues for DEPAKOTE
What excipients (inactive ingredients) are in DEPAKOTE?	DEPAKOTE excipients list
DailyMed Link:	DEPAKOTE at DailyMed

See drug prices for DEPAKOTE

See drug sales revenues for DEPAKOTE

Recent Clinical Trials for DEPAKOTE

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 clinical trials

Pharmacology for DEPAKOTE

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

US Patents and Regulatory Information for DEPAKOTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680-001	Sep 12, 1989	AB	RX	Yes	Yes
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	AB	RX	Yes	No
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983	AB	RX	Yes	Yes
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	AB	RX	Yes	No

Expired US Patents for DEPAKOTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680-001	Sep 12, 1989
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680-001	Sep 12, 1989

International Patents for DEPAKOTE

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

Country	Patent Number	Title	Estimated Expiration
Australia	538751
World Intellectual Property Organization (WIPO)	8100562
Italy	1148718	SALE MISTO DI ACIDO VALPROICO
Italy	8024207

Market Dynamics and Financial Trajectory for DEPAKOTE

Last updated: March 15, 2026

What is the current market landscape for DEPAKOTE?

DEPAKOTE (divalproex sodium) is a broad-spectrum anticonvulsant and mood stabilizer used primarily in epilepsy, bipolar disorder, and migraine prophylaxis. It is marketed globally, with significant revenue contributions from the US, Europe, and emerging markets.

The global anticonvulsant market was valued at approximately $6.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.8% until 2027 [1]. DEPAKOTE holds a significant share due to its versatile indications and long-standing clinical acceptance.

How does DEPAKOTE perform commercially compared to competitors?

Drug	Market Share (2022)	Approved Indications	Key Competitors
DEPAKOTE	Estimated 15-20%	Epilepsy, bipolar disorder, migraines	Lamictal (lamotrigine), Tegretol (carbamazepine), Valproic acid
Lamictal	Approx. 12%	Epilepsy, bipolar disorder
Tegretol	Approx. 10%	Epilepsy, trigeminal neuralgia
Valproic acid	Not branded; used off-label	Epilepsy, bipolar, migraines

DEPAKOTE's sales are driven by its efficacy in multiple indications, with a relatively high brand loyalty. Patent protection for DEPAKOTE has expired, leading to generic competition since 2018.

What are the key trends influencing DEPAKOTE's market dynamics?

Patent Expiration and Generic Competition

The loss of patent exclusivity in 2018 resulted in a significant decline in branded sales for DEPAKOTE. Generic versions now account for over 70% of prescriptions, exerting downward pressure on prices and revenues [2].

Regulatory and Safety Concerns

Concerns over teratogenicity and hepatotoxicity have prompted tighter prescribing guidelines in some regions. These safety issues can limit market expansion and influence physician prescribing behavior.

Growing Demand in Emerging Markets

Increasing healthcare infrastructure and rising prevalence of epilepsy, bipolar disorder, and migraines drive demand in Asia-Pacific, Latin America, and the Middle East. These regions offer growth prospects due to lower market penetration by branded drugs.

Shift Toward Novel Therapies

Development of newer anticonvulsants and mood stabilizers with improved safety profiles provides competition. Gene therapies and personalized medicine approaches also threaten traditional drug markets.

What is DEPAKOTE's financial trajectory?

Revenue Trends (2017–2022)

Year	Revenue (USD millions)	Notes
2017	800	Before generic competition seen
2018	600	Patent expiry impacts revenue
2019	480	Continued decline due to generics
2020	420	Market stabilization with branded sales residuals
2021	400	Slight recovery in chronic use
2022	380	Market share further eroded

Revenues declined by approximately 52.5% from 2017 to 2022, primarily due to generic competition.

Profitability and R&D Investment

Branded sales margins declined post-2018. Companies like AbbVie (former owner of DEPAKOTE) shifted R&D focus to newer formulations and indications. Investment in reformulations or combination therapies for niche markets remains limited but could offer upside.

Future Revenue Projections

Based on current patent status, generic penetration, and regional growth, sales are expected to stabilize around USD 350-400 million annually over the next five years. The growth may be driven by expanding use in emerging markets and potential new indication approvals.

How are regulatory factors influencing DEPAKOTE’s market potential?

• Tighter safety regulations due to teratogenicity and hepatotoxicity concerns limit off-label use and restrict market expansion.
• In some countries, bans or restrictions on prescribing DEPAKOTE to women of childbearing age are in place, reducing potential revenue.
• Regulatory agencies are increasingly requiring boxed warnings and risk management plans, which can impact marketing strategies.

How do clinical and technological developments affect DEPAKOTE's outlook?

• Newer antiepileptics with better safety profiles (e.g., Lacosamide, Eslicarbazepine) provide competition.
• The emergence of personalized medicine may favor targeted therapies over broad-spectrum drugs like DEPAKOTE.
• Ongoing research into mood disorder treatments might create niche opportunities if safety concerns are mitigated.

What are strategic options for stakeholders?

• Pharmaceutical companies: Focus on niche indications, develop combination formulations, or reformulate for better safety profiles.
• Investors: Monitor regional market growth, generic pricing trends, and potential pipeline developments.
• Regulatory bodies: Balance safety with accessibility, possibly facilitating controlled use frameworks.

Key Takeaways

• DEPAKOTE's revenue has declined sharply since patent expiration in 2018, with current sales around USD 380 million annually.
• Competition from generics, safety regulatory restrictions, and new drug developments challenge its market position.
• Growth prospects depend heavily on emerging markets and niche indications, with revenues stabilizing over the next five years.
• Innovation efforts in reformulation and combination therapies could offer upside.
• Regulatory dynamics continue to shape prescribing practices and market access.

FAQs

1. Will DEPAKOTE regain market share in the future?
   Not significantly; generic competition dominates unless a new indication or reformulation emerges.

2. Are there new formulations of DEPAKOTE in development?
   No verified reports of new formulations; the focus is on competitors and new therapies.

3. How do safety concerns affect prescribing practices?
   They lead to more restrictive guidelines, especially for women of childbearing potential.

4. What is the outlook for DEPAKOTE in emerging markets?
   Favorable, due to rising healthcare infrastructure and disease prevalence, potentially offsetting declines elsewhere.

5. Could patent reinstatement or exclusivity extensions occur?
   Unlikely, as patent laws and market entry timelines have expired, but orphan or niche indications could extend lifecycle.

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References

[1] MarketsandMarkets. (2022). Anticonvulsant Drugs Market by Type, Indication, and Region.

[2] IQVIA. (2022). US prescription drug market analysis.