DEPAKOTE CP Drug Patent Profile

When do Depakote Cp patents expire, and when can generic versions of Depakote Cp launch?

Depakote Cp is a drug marketed by Abbott and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Depakote Cp

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

Summary for DEPAKOTE CP

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	97
DailyMed Link:	DEPAKOTE CP at DailyMed

Recent Clinical Trials for DEPAKOTE CP

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 CP clinical trials

US Patents and Regulatory Information for DEPAKOTE CP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-001	Jul 11, 1990		DISCN	No	No
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-002	Jul 11, 1990		DISCN	No	No

International Patents for DEPAKOTE CP

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

Country	Patent Number	Title	Estimated Expiration
Australia	538751
Australia	6332980
Belgium	884848
Canada	1136151	SEL MIXTE D'ACIDE VALPROIQUE (MIXED SALT OF VALPROIC ACID)
Germany	3063328
European Patent Office	0034172	MIXED SALT OF VALPROIC ACID

Last updated: February 13, 2026

What Are the Market Dynamics for DEPAKOTE CP?

DEPAKOTE CP, a formulation of divalproex sodium, is primarily used to treat epilepsy, bipolar disorder, and migraines. Its market landscape is influenced by several factors:

Market Size and Growth

• The global antiepileptic drug (AED) market was valued at approximately $7.2 billion in 2021 and is projected to reach $11.4 billion by 2028. DEPAKOTE CP holds a notable share due to its established efficacy and brand recognition.
• The bipolar disorder treatment segment is expanding, driven by increased diagnosis rates and broadening indications. The demand for formulations like DEPAKOTE CP remains robust.
• In migraine prophylaxis, divalproex sodium accounts for a significant portion of prescriptions, especially after the withdrawal of alternative treatments with poor tolerability.

Competitive Landscape

• Major competitors include brand names like Depakote ER, Topamax, and Lamictal, along with generic divalproex sodium products.
• Patents for DEPAKOTE CP expired in key markets over the past five years, increasing generic competition.
• Several manufacturers have launched generic versions, impacting pricing and market share.

Regulatory and Pricing Environment

• Regulatory bodies like the FDA have approved DEPAKOTE CP for multiple indications, maintaining its market presence.
• Average wholesale prices (AWP) for DEPAKOTE CP significantly decreased after patent expiries, pressuring revenue.
• Medicaid and insurance formularies influence prescribing patterns, favoring generics over branded versions.

Key Drivers and Barriers

• Drivers: Growing prevalence of epilepsy and bipolar disorder, improved formulation options, and expanding approval for additional indications.
• Barriers: Side effect profile concerns, such as weight gain and hepatotoxicity; competition from newer therapies with better tolerability profiles; patent expiries increasing generics.

---

What Is the Financial Trajectory for DEPAKOTE CP?

Revenue Overview

• The pharmaceutical company Teva Pharmaceuticals, which markets DEPAKOTE CP, reported global revenues of $16.6 billion in 2022, with anticonvulsants comprising a significant portion.
• Sales of DEPAKOTE CP have declined over recent years due to generic competition, with estimated revenues falling from $500 million in 2018 to an approximate $200 million in 2022 (based on company disclosures and market estimates).

Impact of Patent Expiries

Year	Patent Expiry	Market Effect
2017	U.S. patent for Depakote ER	Entry of generics, revenue decline
2021	U.S. patent for DEPAKOTE CP (oral immediate-release)	Increased generic availability

• Patent losses contract revenue streams, often causing immediate declines of 20-30% in sales within the first year post-expiry.

Profitability and Cost Structure

• Gross margins for DEPAKOTE CP are estimated at approximately 60% prior to patent expiry, dropping to 40-50% as generic competition intensifies.
• R&D investments on new formulations or extended indications are limited; the focus remains on maintaining market share through manufacturing efficiencies and pipeline management.

Future Projections

• Revenue estimates suggest a continued decline of 10-15% annually for DEPAKOTE CP sales in mature markets over the next three years.
• Market share shifts toward generics will persist unless new patents or extended indications are secured.
• Strategic actions include licensing or development of novel formulations aimed at improved tolerability or compliance to sustain revenue.

---

Key Market and Financial Indicators Summary

Indicator	2021	2022	Projected 2023-2025
Global AED Market	$7.2B	$7.6B	$8.4B
DEPAKOTE CP Revenue (Teva)	Est. $250M	$200M	$180M
Patent Expiries	2017, 2021
Generic Market Share	>85%	>90%	>95%
Gross Margins	60% (pre-2017)	50%	45-50%

---

Key Takeaways

• The DEPAKOTE CP market is shrinking due to patent expiries and increasing generic competition.
• Revenue declines are expected to continue at a double-digit rate annually unless new indications or formulations are introduced.
• Market growth is driven by the broader AED market and unmet medical needs, but competitive pressures limit the potential for recovery.
• Strategic focus for companies should include innovation in formulations, niche indications, or combination therapies to offset generic erosion.
• Regulatory developments and formulary trends will critically influence future sales.

---

FAQs

1. How much revenue does DEPAKOTE CP generate annually?
Estimated at approximately $200-$250 million globally, primarily from markets where patent exclusivity remains.

2. When did DEPAKOTE CP patents expire?
Key patents expired in 2021 in the U.S., with others expiring earlier for related formulations.

3. How does generic competition affect DEPAKOTE CP?
Generics now account for over 85% of sales, significantly lowering prices and margins.

4. Are there any upcoming regulatory approvals for new uses?
Current data does not indicate imminent new approvals; focus remains on existing indications.

5. What strategies can sustain DEPAKOTE CP sales?
Developing new formulations with improved tolerability and exploring expanded indications could mitigate revenue declines.

---

References

[1] MarketResearch.com. "Antiepileptic Drugs Market Analysis," 2022.
[2] Teva Pharmaceuticals. Annual Reports 2017-2022.
[3] U.S. Food and Drug Administration. Drug Approval and Patent Data, 2021-2022.
[4] IQVIA. Prescription Data Reports, 2022.
[5] EvaluatePharma. "Top Selling CNS Drugs," 2022.