Divalproex sodium - Generic Drug Details

What are the generic sources for divalproex sodium and what is the scope of freedom to operate?

Divalproex sodium is the generic ingredient in four branded drugs marketed by Abbvie, Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Invatech, Lupin, Mylan, Norvium Bioscience, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, Utopic Pharms, and Wockhardt, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for divalproex sodium. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for divalproex sodium

US Patents:	0
Tradenames:	4
Applicants:	31
NDAs:	40
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	68
Patent Applications:	7,027
Drug Prices:	Drug price trends for divalproex sodium
What excipients (inactive ingredients) are in divalproex sodium?	divalproex sodium excipients list
DailyMed Link:	divalproex sodium at DailyMed

See drug prices for divalproex sodium

See drug sales revenues for divalproex sodium

Recent Clinical Trials for divalproex sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Syneos Health	Phase 1
Nuventra	Phase 1
Emalex Biosciences Inc.	Phase 1

See all divalproex sodium clinical trials

Generic filers with tentative approvals for DIVALPROEX SODIUM

Applicant	Application No.	Strength	Dosage Form
		EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL
		EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL
		EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for divalproex sodium

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

Paragraph IV (Patent) Challenges for DIVALPROEX SODIUM

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 divalproex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	077615-001	Jul 29, 2008	AB	RX	No	No
Impax Labs	DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	078791-001	May 6, 2009		DISCN	No	No
Aurobindo Pharma Ltd	DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	202419-001	Jun 2, 2014	AB	RX	No	No
Endo Operations	DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	078445-001	Feb 26, 2009		DISCN	No	No

Expired US Patents for divalproex sodium

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	5,212,326*PED
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-001	Jul 11, 1990	5,212,326*PED
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	6,511,678*PED
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	4,913,906*PED

Divalproex sodium Market Analysis and Financial Projection Experimental

Divalproex Sodium Market Dynamics and Financial Trajectory

Market Overview

Divalproex sodium, an FDA-approved anti-epileptic drug, is widely used to treat migraine headaches, certain types of seizures, and manic episodes of bipolar disorders. The market for this drug is experiencing significant growth, driven by several key factors.

Market Drivers

Growing Incidence Rates of Bipolar Disorders

The increasing prevalence of bipolar disorders worldwide is a major driver of the divalproex sodium market. According to the World Health Organization (WHO), bipolar disorder has a lifetime prevalence of about 1% and a one-year prevalence of about 0.5% globally. The COVID-19 pandemic has further exacerbated mental health issues, with a 26% and 28% increase in depressive disorders and anxiety, respectively, in just one year[1][2][4].

Expanding Patient Pool with Epilepsy and Migraine Headaches

The global patient pool affected by epilepsy and migraine headaches is also driving market growth. Approximately 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. In the United States, 17.1% of women and 5.6% of men report having migraine symptoms, contributing to the high demand for divalproex sodium[1][2][4].

Increasing Government Initiatives and Research and Development

Government initiatives and rising research and development activities aimed at introducing new products are crucial for market expansion. For instance, the approval of new formulations, such as the extended-release tablets by Unichem Laboratories, has boosted the market. Increased healthcare investments and the establishment of health insurance schemes have also improved access to prescription medications, driving demand for divalproex sodium[1][2][5].

Market Restraints

Stringent Regulations

The divalproex sodium market faces challenges due to stringent regulations and black box warnings from regulatory bodies like the FDA. These warnings highlight the risks of hepatotoxicity, pancreatitis, and fetal harm associated with divalproex sodium use, which can deter some patients and healthcare providers[1][2][4].

Neurobehavioral Adverse Effects and Birth Defects

The use of divalproex sodium is associated with neurobehavioral adverse effects, birth defects, and suicidal tendencies, which are significant restraints on the market. These side effects necessitate careful patient monitoring and can limit the drug's adoption in certain cases[1][2].

Market Segmentation

By Form Type

The divalproex sodium market is segmented into capsules, tablets, and syrup. Tablets, particularly extended-release and delayed-release formulations, are a significant growth driver due to their convenience and therapeutic benefits[2][4][5].

By Application

The market is segmented by application into epilepsy, manic-depressive illness, and other applications. The treatment of epilepsy and migraine headaches constitutes the largest share of the market, driven by the high prevalence of these conditions[1][2][4].

By Region

North America, particularly the United States, holds the largest market share due to high incidence rates of epilepsy and migraines, advanced healthcare infrastructure, and robust government support. The Asia-Pacific region is the fastest-growing market, driven by expanding healthcare systems and increasing awareness of mental health[1][2][5].

Financial Trajectory

Current Market Size

The global divalproex sodium market was estimated at USD 2.37 billion in 2022 and is projected to reach USD 3.38 billion by 2028, growing at a CAGR of 6.04% during the forecast period of 2023-2028[4].

Future Growth Projections

The market is expected to continue its growth trajectory, driven by the increasing prevalence of neurological disorders, expanding generic drug production, and growing healthcare investments. The divalproex sodium API market, valued at USD 2188.5 million in 2023, is anticipated to reach USD 3363.6 million by 2030, witnessing a CAGR of 6.2% during the forecast period of 2024-2030[5].

Key Players

The market is consolidated, with major players such as AbbVie Inc., Zydus Cadila, Aurobindo Pharma, Dr. Reddy's Laboratories Ltd, and Lupin Pharmaceuticals Inc. dominating the landscape. These companies are actively involved in expanding their product offerings and enhancing their market presence through strategic approvals and launches[1][2][4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the divalproex sodium market. Initially, it altered healthcare delivery methods, with increased use of telemedicine and decreased in-person outpatient visits. However, the pandemic has also underscored the importance of mental health, potentially boosting demand for divalproex sodium due to rising cases of bipolar disorder and other mental health issues[1][2][4].

Regulatory Environment

Regulatory standards requiring high-quality APIs have driven the demand for divalproex sodium APIs with superior purity and consistency. Pharmaceutical companies must comply with strict guidelines to enter regulated markets like the U.S. and Europe, which ensures drug safety and efficacy and aligns with patient safety priorities[5].

Regional Variations

North America leads the market due to high prevalence rates of neurological disorders and advanced healthcare infrastructure. The Asia-Pacific region is emerging as a significant market, driven by expanding healthcare systems and increasing awareness of mental health. Europe also holds a substantial market share, with a focus on compliance with regulatory standards[1][2][5].

"1 in every 8 people in the world live with a mental disorder. Due to the COVID-19 pandemic, the number of people who suffer from anxiety and depressive illnesses greatly increased in 2020." - World Health Organization (WHO)[1].

Key Takeaways

• The divalproex sodium market is projected to grow at a CAGR of 6.2% during the forecast period, driven by increasing incidence rates of bipolar disorders, epilepsy, and migraine headaches.
• Government initiatives and rising research and development activities are crucial for market expansion.
• The market faces challenges due to stringent regulations and adverse effects associated with the drug.
• North America holds the largest market share, with the Asia-Pacific region being the fastest-growing market.
• The financial trajectory indicates significant growth, with the market expected to reach USD 3.38 billion by 2028.

FAQs

What is the current global divalproex sodium market size?

The global divalproex sodium market was estimated at USD 2.37 billion in 2022[4].

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, and Lupin Pharmaceuticals Inc.[1][2][4].

What are the major factors driving the growth of the divalproex sodium market?

The growth is driven by the increasing prevalence of bipolar disorders, rising patient pool with epilepsy and migraine headaches, increasing government initiatives, and rising research and development activities[1][2][4].

How has the COVID-19 pandemic impacted the divalproex sodium market?

The pandemic has altered healthcare delivery methods and increased the demand for divalproex sodium due to rising mental health issues, but it also presented initial challenges in market growth[1][2][4].

What are the primary forms of divalproex sodium used in the market?

The primary forms include capsules, tablets (especially extended-release and delayed-release), and syrup[2][4][5].

Sources

1. Mordor Intelligence: Global Divalproex Sodium Market Size | Mordor Intelligence
2. Mordor Intelligence: Divalproex Sodium Market Size & Share Analysis - Mordor Intelligence
3. Cognitive Market Research: Divalproex Sodium Market Report 2024 (Global Edition)
4. Stratview Research: Divalproex Sodium Market Size, Share, & Growth Analysis
5. PR Newswire: Divalproex Sodium API Market to Witness 6.2% CAGR - PR Newswire