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-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

A generic version of DEPAKOTE was approved as divalproex sodium by APOTEX 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:	67
Clinical Trials:	97
Patent Applications:	5,047
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
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-003	Oct 26, 1984	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	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680-001	Sep 12, 1989
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-003	Oct 26, 1984

International Patents for DEPAKOTE

See the table below for patents covering DEPAKOTE 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

DEPAKOTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Depakote (Divalproex Sodium)

Market Overview

Depakote, also known as divalproex sodium, is a valproate medication widely used for the treatment of manic episodes associated with bipolar disorder, as well as for the management of epilepsy and migraine headaches. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Drivers

Growing Incidence Rates of Bipolar Disorders

The increasing prevalence of bipolar disorders is a significant driver for the Depakote market. Bipolar disorder affects a substantial portion of the population, and the need for effective treatments continues to grow. According to various studies, the global burden of bipolar disorders contributes to the rising demand for medications like Depakote[4].

Expanding Patient Pool with Epilepsy and Migraine Headaches

Epilepsy and migraine headaches are common neurological conditions that require ongoing treatment. The World Health Organization estimates that around 50 million people worldwide have epilepsy, with high incidence rates in both high-income and low- and middle-income countries. This expanding patient pool drives the demand for antiepileptic and antimigraine medications, including Depakote[1].

Increasing Government Initiatives and Rising Research and Development Activities

Government initiatives and advancements in research and development play crucial roles in the growth of the Depakote market. Increased funding for neurological disorder research and the launch of new therapeutic products are expected to aid market growth. Additionally, campaigns like National Epilepsy Awareness Month help raise awareness and advocacy for mental health and neurological disorders, further propelling market growth[4].

Market Restraints

Stringent Regulations

The use of Depakote is subject to stringent regulations due to its potential for severe adverse effects. The FDA has issued black box warnings highlighting the risks of hepatotoxicity, pancreatitis, and fetal harm associated with divalproex sodium use. These warnings can limit the market growth as they may deter some patients and healthcare providers from using the drug[5].

Increasing Neurobehavioral Adverse Effects, Birth Defects, and Suicidal Tendencies

Depakote is associated with several serious side effects, including neurobehavioral adverse effects, birth defects, and suicidal tendencies. These risks can lead to a decrease in prescription rates and affect the overall market size. For instance, valproate can cause fetal harm when administered to pregnant women, leading to structural birth defects and decreased IQ[5].

Market Segmentation

By Type

The Depakote market is segmented by type into tablets, capsules, and syrup. Each form has its own market share and growth prospects, with tablets being a dominant form due to their ease of administration and stability[4].

By Application

The primary applications of Depakote include the treatment of epilepsy and migraine headaches, as well as manic episodes associated with bipolar disorder. The market is also segmented into other applications, but these three are the most significant drivers of demand[4].

Regional Analysis

Largest Market: North America

North America, particularly the United States, holds the largest market share for Depakote. This is due to the high prevalence of epilepsy and bipolar disorders in the region, coupled with significant government initiatives and research and development activities. The U.S. market is expected to continue growing, driven by increasing product approvals by the FDA[1][3].

Fastest Growing Market: Asia-Pacific

The Asia-Pacific region is projected to be the fastest-growing market for Depakote. This growth is attributed to increasing regulatory approvals, the penetration of key regional players, and the growing awareness and advocacy for mental health and neurological disorders in the region[1][3].

Financial Trajectory

Market Size and Growth Rate

The global Depakote market is projected to register a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period from 2022 to 2027. This growth is driven by the expanding patient pool affected by epilepsy, bipolar disorders, and migraine headaches, as well as increasing government initiatives and research and development activities[1][4].

Revenue Projections

The market size of Depakote is expected to increase significantly over the forecast period. The global antiepileptic drugs market, which includes Depakote, is projected to grow from $17.13 billion in 2024 to $24.85 billion by 2032, exhibiting a CAGR of 4.8% during this period. The North American market, which is the largest for Depakote, is expected to contribute substantially to this growth[3].

Key Players

The Depakote market is characterized by the presence of several major players, including:

• AbbVie Inc.
• Lupin Pharmaceuticals, Inc.
• Dr. Reddy's Laboratories Ltd.
• Zydus Cadila
• Aurobindo Pharma

These companies are involved in various strategies such as product innovation, mergers and acquisitions, and market expansion to maintain their market positions[1][4].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the healthcare sector, including the Depakote market. Initially, the pandemic led to a decrease in in-person outpatient visits and an increase in telemedicine use, which affected the delivery of healthcare services. However, it also underscored the importance of mental health and neurological disorder treatment, potentially boosting demand for Depakote in the long term[1][4].

Key Takeaways

• Growing Demand: The market for Depakote is driven by the increasing prevalence of epilepsy, bipolar disorders, and migraine headaches.
• Regulatory Challenges: The market faces challenges due to stringent regulations and black box warnings from regulatory bodies.
• Regional Growth: North America is the largest market, while the Asia-Pacific region is expected to be the fastest-growing.
• Financial Growth: The market is projected to grow at a CAGR of 6.2% from 2022 to 2027.
• Key Players: Major pharmaceutical companies like AbbVie Inc., Lupin Pharmaceuticals, Inc., and others dominate the market.

FAQs

What is the current global market size for Depakote?

The global Depakote 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 Depakote market?

The major companies operating in the global Depakote market include AbbVie Inc., Lupin Pharmaceuticals, Inc., Dr. Reddy's Laboratories Ltd., Zydus Cadila, and Aurobindo Pharma[1][4].

Which region has the largest share in the global Depakote market?

North America, particularly the United States, holds the largest market share for Depakote[1][3].

What are the primary applications of Depakote?

The primary applications of Depakote include the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy for complex partial seizures and absence seizures, and prophylaxis of migraine headaches[2][5].

What are the major side effects associated with Depakote?

Depakote is associated with serious side effects such as hepatotoxicity, pancreatitis, fetal harm, and neurobehavioral adverse effects. Children under two years old and patients with mitochondrial disorders are at higher risk of fatal hepatotoxicity[2][5].