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Last Updated: December 22, 2024

DIVALPROEX SODIUM Drug Patent Profile


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When do Divalproex Sodium patents expire, and when can generic versions of Divalproex Sodium launch?

Divalproex Sodium is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, 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 thirty-six NDAs.

The generic ingredient in DIVALPROEX SODIUM 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 Divalproex Sodium

A generic version of DIVALPROEX SODIUM was approved as divalproex sodium by APOTEX on July 29th, 2008.

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Summary for DIVALPROEX SODIUM
Drug patent expirations by year for DIVALPROEX SODIUM
Drug Prices for DIVALPROEX SODIUM

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Drug Sales Revenue Trends for DIVALPROEX SODIUM

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Recent Clinical Trials for DIVALPROEX SODIUM

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

SponsorPhase
NuventraPhase 1
Emalex Biosciences Inc.Phase 1
Syneos HealthPhase 1

See all DIVALPROEX SODIUM clinical trials

Pharmacology for DIVALPROEX SODIUM
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
Utopic Pharms DIVALPROEX SODIUM divalproex sodium TABLET, EXTENDED RELEASE;ORAL 214462-001 Mar 15, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 076941-001 Jul 29, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Orbion Pharms DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078853-001 Nov 25, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078182-003 Jul 29, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd DIVALPROEX SODIUM divalproex sodium TABLET, EXTENDED RELEASE;ORAL 090161-001 Mar 15, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem Labs Ltd DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 079163-002 Apr 5, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms Usa Inc DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077100-001 Mar 5, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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