DEPAKOTE ER Drug Patent Profile

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

Depakote Er is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in DEPAKOTE ER 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 Er

A generic version of DEPAKOTE ER was approved as divalproex sodium by APOTEX on July 29^th, 2008.

Summary for DEPAKOTE ER

US Patents:	0
Applicants:	1
NDAs:	1
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 ER
DailyMed Link:	DEPAKOTE ER at DailyMed

See drug prices for DEPAKOTE ER

See drug sales revenues for DEPAKOTE ER

Recent Clinical Trials for DEPAKOTE ER

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 ER clinical trials

Pharmacology for DEPAKOTE ER

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

Paragraph IV (Patent) Challenges for DEPAKOTE ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEPAKOTE ER	Extended-release Tablets	divalproex sodium	500 mg	021168		2005-02-08
DEPAKOTE ER	Extended-release Tablets	divalproex sodium	250 mg	021168		2004-05-03

US Patents and Regulatory Information for DEPAKOTE ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	AB	RX	Yes	No
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	AB	RX	Yes	No

Expired US Patents for DEPAKOTE ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	4,913,906*PED
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	6,713,086*PED
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	6,511,678*PED

International Patents for DEPAKOTE ER

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

Country	Patent Number	Title	Estimated Expiration
Japan	S56501161
Poland	356899
Norway	20012986

DEPAKOTE ER Market Analysis and Financial Projection Experimental

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

Introduction to DEPAKOTE ER

DEPAKOTE ER, containing the active ingredient divalproex sodium, is a widely prescribed medication for treating bipolar disorder, epilepsy, and migraine headaches. This article delves into the market dynamics, growth drivers, and financial trajectory of the divalproex sodium market, with a focus on DEPAKOTE ER.

Market Size and Growth Projections

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

Base Year and Forecast Period

• The base year for estimation is 2023, and the study period spans from 2019 to 2029[1].

Regional Market Share

• North America, particularly the United States, holds the largest market share due to increased government initiatives and robust research and development activities. However, the Asia-Pacific region is expected to be the fastest-growing market during the forecast period[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Bipolar Disorders

• The global prevalence of bipolar disorders is a significant driver. According to the World Health Organization, bipolar disorder affects approximately 1% of the global population over a lifetime, with a one-year prevalence of about 0.5%[1][4].

Rising Patient Pool with Epilepsy and Migraine

• The expanding patient pool affected by epilepsy and migraine headaches also propels market growth. Approximately 50 million people worldwide suffer from epilepsy, and the global prevalence of migraine is estimated at 14.7%[1][4].

Government Initiatives and R&D

• Increased government initiatives and rising research and development activities aimed at launching new products are crucial for market growth. For instance, the National Quality Strategy (NQS) in the U.S. has driven quality improvement in healthcare, supporting the development of new treatments[4].

Market Dynamics

Impact of COVID-19

• The COVID-19 pandemic has had a mixed impact on the market. While it led to a decrease in in-person outpatient visits and an increase in telemedicine, it also heightened the need for effective treatments for mental health disorders and neurological conditions, which in turn boosted the demand for divalproex sodium[1].

Competitive Landscape

• The market is characterized by low concentration, with several major players including AbbVie Inc., Lupin Pharmaceuticals, Inc., Dr. Reddy's Laboratories Ltd., Zydus Cadila, and Aurobindo Pharma. These companies are actively involved in research and development to introduce new products and formulations[1][4].

Financial Trajectory

Revenue and CAGR

• The divalproex sodium market is expected to register a CAGR of 6.2% during the forecast period, indicating steady revenue growth. This growth is driven by the increasing demand for effective treatments for bipolar disorder, epilepsy, and migraine headaches[1].

Pricing Strategies

• The pricing of divalproex sodium products, including DEPAKOTE ER, is influenced by the economic implications of developing precision medicines. Given the small patient population for some of these conditions, firms often set higher prices to justify the significant research and development investments[3].

Generic Competition

• The introduction of generic versions of DEPAKOTE ER, such as Mylan's generic launch in 2008, has posed a challenge to the market growth. However, brand loyalty and ongoing research and development by major players help maintain market share[4].

Side Effects and Regulatory Considerations

Severe Side Effects

• DEPAKOTE ER has boxed warnings for severe liver damage and pancreatitis, which can be life-threatening. These side effects, along with others like birth defects and neurobehavioral adverse effects, are significant concerns that can impact market growth[2].

Regulatory Environment

• The FDA's strict regulations and warnings associated with divalproex sodium use, particularly in pregnant women and children under two years old, also influence the market dynamics. These regulations ensure that the drug is used cautiously, which can affect its adoption rate[2].

Regional Insights

North America

• North America, led by the U.S., holds the largest market share due to strong government initiatives and robust R&D activities. The incidence of epilepsy and migraine in the U.S. is high, contributing to the demand for divalproex sodium[1][4].

Asia-Pacific

• The Asia-Pacific region is expected to show significant growth due to the increasing prevalence of epilepsy and migraine among the population. Countries like China have seen a rise in epilepsy prevalence, driving the demand for effective treatments[4].

Key Takeaways

• The divalproex sodium market, driven by DEPAKOTE ER, is expected to grow at a CAGR of 6.2% during the forecast period.
• Increasing prevalence of bipolar disorders, epilepsy, and migraine headaches are key growth drivers.
• Government initiatives and R&D activities are crucial for market growth.
• The market faces challenges from generic competition and severe side effects.
• North America holds the largest market share, while the Asia-Pacific region is the fastest-growing.

FAQs

What is the current global market size of 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 major players in the global divalproex sodium market?

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

Which region is the fastest-growing in the global divalproex sodium market?

The Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period[1][4].

What are the primary uses of DEPAKOTE ER?

DEPAKOTE ER is used to treat manic and mixed episodes related to bipolar disorder, prevent migraine episodes, and treat focal impaired awareness seizures and absence seizures in adults and children ages 10 years and older[2].

What are the severe side effects associated with DEPAKOTE ER?

Severe side effects include liver damage, pancreatitis, and high fetal risk, among others. These side effects have resulted in boxed warnings from the FDA[2].

Sources

1. Mordor Intelligence: Divalproex Sodium Market Size & Share Analysis.
2. Medical News Today: Depakote and Depakote ER: Side effects, dosage, and more.
3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
4. Coherent Market Insights: Divalproex Sodium Market - Share, Size and Industry Analysis.