DEPAKOTE Drug Patent Profile

Which patents cover Depakote, 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

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
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-003	Oct 26, 1984	AB	RX	Yes	No
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983	AB	RX	Yes	No

International Patents for DEPAKOTE

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

Country	Patent Number	Title	Estimated Expiration
Japan	S56501161
World Intellectual Property Organization (WIPO)	8100562
Canada	1136151	SEL MIXTE D'ACIDE VALPROIQUE (MIXED SALT OF VALPROIC ACID)
Belgium	884848
Germany	3063328
Australia	538751

Depekote (Valproate Acid): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Depekote (valproate acid) is a well-established anticonvulsant primarily used for epilepsy, bipolar disorder, and migraines. With an extensive patent history and widespread clinical acceptance, Depekote's market remains robust. However, patent expirations, generic competition, and evolving regulatory landscapes influence its future investment prospects. This analysis evaluates its current market position, the drivers impacting its market dynamics, and projects its financial trajectory over the next five years. It provides strategic insights for investors, pharma companies, and stakeholders considering Depekote’s commercial potential.

---

Market Overview of Depekote

Parameter	Details
Active Ingredient	Valproate Acid (Valproic Acid)
Approved Indications	Epilepsy, Bipolar Disorder, Migraine Prevention
Global Market Size (2022)	USD 3.2 billion (estimated)
Major Markets	USA, Europe, Japan, Emerging Markets
Patent Status	Patents expired in key markets (e.g., US: 2014)
Major Brands	Depekote (AbbVie/Abbott), Depakote (Abbott), others

Source: IQVIA, 2022; Market Research Future, 2022.

---

Investment Scenario for Depekote

Current Valuation and Market Share

• Market Capitalization: As a mature drug, Depekote's revenue is primarily generated through generic formulations following patent expirations.
• Pharmaceutical Revenue (2022): Estimated at USD 1.2 billion globally.
• Market Share Dynamics: Dominated by generics (~85%), with branded products holding minor premium segments (~15%).

Key Revenue Drivers

Driver	Impact
Patent expirations	Accelerated generic entry post-2014
Clinical expansion	Off-label uses and new formulations
Prescribing trends	Increase in bipolar disorder and migraine diagnosis
Pricing strategies	Variability across markets, impact of biosimilars

Investment Risks

Risk Factor	Description
Patent litigation and exclusivity issues	Limited in key markets, reducing protected revenue
Generic price erosion	Significant in mature markets; pressure on margins
Regulatory challenges	Potential restrictions on off-label uses
Market saturation	Limited growth potential in established markets

Opportunities for Investment Growth

Opportunity	Rationale
Geographic expansion into emerging markets	Growing epilepsy and mental health treatment needs
Development of extended-release formulations	Enhances compliance, premium pricing opportunity
Combination therapy development	Synergy with other neuropsychiatric drugs

---

Market Dynamics Influencing Depekote

Product Lifecycle and Patent Landscape

• Patent Timeline: Original patents filed in late 20th century; expired in multiple jurisdictions by 2014.
• Generic Proliferation: Enforced via ANDA filings, leading to price erosion.
• Market Saturation: High saturation in mature markets; growth driven mainly by volume increases.

Competitive Environment

Competitors	Market Presence	Strategy
Generic manufacturers (e.g., Mylan, Teva)	Significant, with multiple equivalent products	Price competition, volume-driven sales
Brand manufacturers (e.g., AbbVie)	Small niche, premium pricing	Maintenance of brand loyalty, innovation

Regulatory and Reimbursement Trends

• FDA & EMA Policies: Relaxed labeling post-patent expiry; increased focus on safety monitoring.
• Insurance & Reimbursement: Favor generic substitution, capitalize on cost savings.
• Off-label Use Regulation: Growing scrutiny can impact prescribing patterns.

Evolving Therapeutic Landscape

Key Trends	Impact on Depekote
Rise of alternative therapies	Newepilepsy drugs, cannabinoids, and neuromodulation
Pharmacogenomics and personalized medicine	Potential for tailored therapy, reducing overall volume
Increased focus on psychiatric treatments	Potential growth in bipolar disorder and migraine markets

---

Financial Trajectory Projection (2023-2027)

Year	Estimated Revenue (USD Million)	Growth Rate	Major Assumptions
2023	1,100	0%	Baseline with existing generics market
2024	1,055	-4%	Continued price erosion, patent expiries
2025	1,010	-4.5%	Market saturation persists
2026	960	-5%	Emerging markets expansion
2027	910	-5%	Competition intensifies; market stiffness

Note: The projection assumes no significant reformulation or new indications are approved, with revenues primarily derived from generic sales.

---

Comparison with Similar Pharmaceuticals

Drug	Indication(s)	Patent Status	2022 US Revenue (USD Million)	Main Competitors
Depakote (brand)	Epilepsy, Bipolar, Migraine	Expired (2014)	USD 150	Mylan, Teva, Sandoz
Tegretol (Carbamazepine)	Epilepsy	Patents expired (~2010)	USD 400	Generic manufacturers
Lamictal (Lamotrigine)	Epilepsy, Bipolar	Patents expired (~2007)	USD 350	Multiple generics

Implication: Depekote's market resembles other first-generation antiepileptics with declining revenues but stable demand in niche segments.

---

Strategic Insights and Recommendations

Strategy Aspect	Recommendations
Diversify indications	Invest in new delivery forms or adjunct therapies
Geographic expansion	Focus on emerging markets with increasing epilepsy and mood disorder prevalence
Intellectual property management	Pursue formulation patents or derivatives
Market differentiation	Leverage manufacturing efficiencies to maintain competitive pricing
R&D investments	Explore combination drugs or biomarker-guided therapies

---

Conclusion

Depekote remains a stable but declining revenue driver amidst a mature, highly competitive market. The primary valuation stemmed from its initial patent-protected phase, which has ceded ground to generics. Future growth hinges on geographic expansion, formulation innovation, and market segmentation. The investment outlook indicates continued revenue erosion but with opportunities in emerging markets and niche indications.

---

Key Takeaways

• Market Maturity: Depekote's patent expiry led to widespread generic adoption, diminishing profit margins.
• Revenue Trends: Expected decline of 5% annually over the next five years, driven by price erosion.
• Growth Opportunities: Focus on emerging markets, novel formulations, and combination therapies can mitigate decline.
• Strategic Risks: Pricing pressures, regulatory challenges, and market saturation remain significant.
• Investment Perspective: Best suited for entities with capabilities in niche markets, manufacturing efficiencies, or geographic expansion.

---

FAQs

Q1: What factors could positively influence Depekote’s market future?
A: Emerging markets’ growth, new formulation development, expanding indications, and strategic collaborations could bolster sales.

Q2: How does patent expiry impact Depekote’s market?
A: Patent expiry invites generic competition, leading to significant price erosion and revenue decline.

Q3: Are there new formulations of Depekote under development?
A: Currently, no pivotal formulations are under clinical development; focus remains on generics and incremental innovations.

Q4: What are the main regulatory challenges faced by Depekote?
A: Post-patent safety labeling updates, off-label use restrictions, and reimbursement policies are key regulatory concerns.

Q5: How does Depekote compare with newer anticonvulsants?
A: Newer drugs like Lamictal have similar indications but often offer improved safety profiles or dosing convenience, challenging Depekote’s market share.

---

References

[1] IQVIA. Global Medicine Spending and Usage Trends. 2022.
[2] Market Research Future. "Antiepileptic Drugs Market," 2022.
[3] U.S. Food & Drug Administration. Drug Approvals and Patent Status. 2022.
[4] Sandoz. Generic Drug Market Data. 2022.
[5] PubMed. Clinical trials and safety updates on valproate drugs. 2021-2022.