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-one 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 APOTEX 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

Expired US Patents for DEPAKOTE CP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-001	Jul 11, 1990	4,988,731*PED
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-002	Jul 11, 1990	5,212,326*PED
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-002	Jul 11, 1990	4,988,731*PED
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-001	Jul 11, 1990	5,212,326*PED

International Patents for DEPAKOTE CP

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8004636
Canada	1136151	SEL MIXTE D'ACIDE VALPROIQUE (MIXED SALT OF VALPROIC ACID)
World Intellectual Property Organization (WIPO)	8100562
Germany	3063328
Australia	538751
Italy	1148718	SALE MISTO DI ACIDO VALPROICO

DEPAKOTE CP Market Analysis and Financial Projection Experimental

Divalproex Sodium Market Dynamics and Financial Trajectory: A Deep Dive into DEPAKOTE

Introduction to Divalproex Sodium and DEPAKOTE

Divalproex sodium, marketed under the brand name DEPAKOTE among others, is a medication widely used for the treatment of epilepsy, bipolar disorder, and migraine headaches. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth Projections

The divalproex sodium market is anticipated to experience significant growth over the forecast period of 2022-2027, with a projected Compound Annual Growth Rate (CAGR) of 6.2%[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Neurological Disorders

The rising prevalence of epilepsy and bipolar disorders globally is a major driver of the divalproex sodium market. According to the World Health Organization, approximately 50 million people worldwide suffer from epilepsy, making it one of the most common neurological diseases. Additionally, the global prevalence of bipolar disorder is estimated to be around 2.4%[1][4].

Migraine Headaches

Migraine headaches also contribute significantly to the demand for divalproex sodium. The global prevalence of migraine was estimated at 14.7% in 2013, affecting around 1 in 7 people[4].

Government Initiatives and R&D Activities

In North America, particularly in the United States, increased government initiatives and rising research and development activities are expected to aid the growth of the divalproex sodium market. For example, the National Quality Strategy (NQS) launched in 2011 has been instrumental in improving healthcare quality, which includes better management of neurological disorders[4].

Regional Market Insights

North America

North America, specifically the United States, holds the largest market share for divalproex sodium. The high incidence of epilepsy and migraine headaches in this region, along with robust healthcare infrastructure and government support, contributes to this dominance. For instance, the incidence of status epilepticus in the United States ranges from 18.3 to 41 per 100,000 people per year[1].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market for divalproex sodium. Increasing prevalence of epilepsy and migraine headaches, coupled with improving healthcare access and awareness, are driving this growth. In China, for example, the lifetime epilepsy prevalence increased from 1.99% in 1990 to 7.15% in 2015[4].

Competitive Landscape

The divalproex sodium market is characterized by a low market concentration, with several major players dominating the market. Key players include AbbVie Inc., Zydus Cadila, Aurobindo Pharma, Dr. Reddy's Laboratories Ltd., Lupin Pharmaceuticals Inc., and Abbott Laboratories. These companies are engaged in various strategies such as mergers, collaborations, and the introduction of new products to maintain their market position[1][4].

Regulatory and Safety Considerations

Despite the growth potential, the divalproex sodium market faces regulatory challenges. The FDA has issued black box warnings for divalproex sodium due to its association with hepatotoxicity, pancreatitis, and high fetal risk, among other adverse effects. These warnings can impact market growth and necessitate careful risk management strategies by manufacturers[4].

Financial Trajectory

Revenue Growth

The revenue growth of the divalproex sodium market is expected to be robust, driven by the increasing demand for the drug. The market's CAGR of 6.2% indicates a steady and significant increase in revenue over the forecast period[1].

Impact of Generic Products

The introduction of generic versions of divalproex sodium, such as Mylan's generic launch of Abbott's Depakote ER in 2008, can impact the financial trajectory of branded products. However, the overall market growth is expected to offset these effects to some extent[4].

Research and Development Investments

Companies are investing heavily in research and development to improve the efficacy and safety of divalproex sodium. For instance, Unichem Laboratories received FDA approval for its Divalproex Sodium extended-release tablets in 2022, which is expected to drive market growth[1].

Clinical Efficacy and Outcomes

Clinical studies have consistently shown the efficacy of divalproex sodium in treating various conditions. For example, studies comparing divalproex sodium with placebo in patients with manic episodes and migraine headaches have demonstrated significant improvements in symptoms and outcomes[2].

"DEPAKOTE was statistically significantly superior to placebo on all three measures of outcome," as noted in clinical trials assessing its efficacy in treating manic episodes and migraine headaches[2].

Market Challenges and Opportunities

Challenges

• Regulatory Hurdles: The black box warnings and associated risks with divalproex sodium can limit market growth.
• Generic Competition: The availability of generic products can reduce the market share of branded products.
• Side Effects: The drug's side effects, such as hepatotoxicity and pancreatitis, require careful management and monitoring.

Opportunities

• Expanding Patient Pool: The increasing prevalence of epilepsy and migraine headaches globally presents a significant opportunity for growth.
• Government Initiatives: Increased government support for healthcare quality improvement and research can drive market expansion.
• Emerging Markets: The Asia-Pacific region offers substantial growth potential due to its large and growing patient population.

Key Takeaways

• The divalproex sodium market is projected to grow at a CAGR of 6.2% from 2022 to 2027.
• North America holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing market.
• Increasing prevalence of neurological disorders and government initiatives are key drivers of market growth.
• Regulatory challenges and generic competition are significant factors to consider.
• Clinical efficacy and ongoing research and development activities support the market's financial trajectory.

Frequently Asked Questions (FAQs)

What is the current global market size for divalproex sodium?

The global divalproex sodium market is projected to register a CAGR of 6.20% during the forecast period (2024-2029), but the exact current market size is not specified in the sources provided.

Who are the key players in the global divalproex sodium market?

Key players include AbbVie Inc., Zydus Cadila, Aurobindo Pharma, Dr. Reddy's Laboratories Ltd., Lupin Pharmaceuticals Inc., and Abbott Laboratories[1][4].

Which region has the biggest share in the global divalproex sodium market?

North America, specifically the United States, holds the largest market share in the global divalproex sodium market[1][4].

What are the primary uses of divalproex sodium?

Divalproex sodium is primarily used for the treatment of epilepsy, bipolar disorder, and migraine headaches[1][2].

What are the significant side effects associated with divalproex sodium?

Significant side effects include hepatotoxicity, pancreatitis, high fetal risk, birth defects, neurobehavioral adverse effects, and suicidal behavior[4].

Sources:

1. Mordor Intelligence - Divalproex Sodium Market Size & Share Analysis
2. FDA - Depakote Tablets (divalproex sodium) Tablet
3. PsychRights - R E P O R T - Law Project for Psychiatric Rights
4. Coherent Market Insights - Divalproex Sodium Market - Share, Size and Industry Analysis