Ethosuximide - Generic Drug Details

What are the generic sources for ethosuximide and what is the scope of patent protection?

Ethosuximide is the generic ingredient in two branded drugs marketed by Bionpharma, Epic Pharma Llc, Heritage Pharms Inc, Puracap Pharm Llc, Strides Pharma, Parke Davis, Mikart, Pharm Assoc, Teva Pharms, and Parke-davis, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ethosuximide. Nine suppliers are listed for this compound.

Summary for ethosuximide

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	12
Patent Applications:	6,270
Drug Prices:	Drug price trends for ethosuximide
What excipients (inactive ingredients) are in ethosuximide?	ethosuximide excipients list
DailyMed Link:	ethosuximide at DailyMed

See drug prices for ethosuximide

Recent Clinical Trials for ethosuximide

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

Sponsor	Phase
Johns Hopkins University	Phase 3
Tanta University	Phase 3
Zhejiang University	Early Phase 1

See all ethosuximide clinical trials

Pharmacology for ethosuximide

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

Medical Subject Heading (MeSH) Categories for ethosuximide

Anticonvulsants

Anatomical Therapeutic Chemical (ATC) Classes for ethosuximide

N03AD	Succinimide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for ethosuximide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puracap Pharm Llc	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	210654-001	Mar 16, 2020	AB	RX	No	No
Strides Pharma	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	211928-001	Feb 19, 2019	AB	RX	No	No
Bionpharma	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	040430-001	Oct 28, 2002	AB	RX	No	No
Mikart	ETHOSUXIMIDE	ethosuximide	SYRUP;ORAL	040506-001	Dec 22, 2003	AA	RX	No	No
Teva Pharms	ETHOSUXIMIDE	ethosuximide	SYRUP;ORAL	081306-001	Jul 30, 1993		DISCN	No	No
Heritage Pharms Inc	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	200892-001	Sep 25, 2012	AB	RX	No	No
Parke Davis	ZARONTIN	ethosuximide	CAPSULE;ORAL	012380-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Ethosuximide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethosuximide

Introduction to Ethosuximide

Ethosuximide is a medication primarily used to treat absence seizures, a type of epilepsy. It is one of the first-line treatments for childhood absence epilepsy due to its efficacy and relatively favorable side effect profile.

Market Size and Growth

The global ethosuximide market is anticipated to experience steady growth over the coming years. Here are some key statistics:

• The market size was valued at USD 0.57 billion in 2023 and is expected to reach USD 0.72 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2031[4].
• Another report indicates that the market is expected to grow at a CAGR of 4% during the forecast period of 2024-2032[1].

Market Drivers

Several factors are driving the growth of the ethosuximide market:

• Increasing Incidence of Epilepsy: The rising prevalence of epilepsy, particularly in children, is a significant driver. Childhood absence epilepsy is a common form of epilepsy in children, and ethosuximide is often the preferred treatment[3].
• Advances in Treatment Technology: Continuous advancements in pharmaceutical technology and the development of new formulations are contributing to the market's growth.
• Government Funding and Initiatives: Increased government funding for healthcare and initiatives to improve epilepsy treatment are also boosting the market[3].

Market Segmentation

The ethosuximide market can be segmented in various ways:

• By Geography: The market is segmented into regions such as North America, Europe, Asia Pacific, and the rest of the world. North America holds a significant share due to the presence of major pharmaceutical companies and a well-developed healthcare sector[3].
• By Drug Type: Ethosuximide is part of the broader antiepileptic drug market, which includes other drugs like valproate and lamotrigine. However, ethosuximide remains a preferred choice for childhood absence epilepsy due to its specific efficacy in this condition[3].

Competitive Landscape

The ethosuximide market is characterized by the presence of several key pharmaceutical companies:

• Major Players: Companies such as Jazz Pharmaceuticals, Pfizer Inc., Teva Pharmaceutical Industries Ltd., AbbVie Inc., and GlaxoSmithKline plc are significant players in the antiepileptic drug market, including ethosuximide[3].
• Market Share and Strategies: These companies engage in various strategies such as product development, mergers and acquisitions, and market expansion to maintain their market share. For example, AbbVie's acquisition of Allergan plc has strengthened its position in the market[3].

Financial Costs and Accessibility

The financial aspect of ethosuximide treatment is crucial for patients and healthcare systems:

• Cost of Treatment: While ethosuximide is generally more affordable than some newer antiepileptic drugs, access can still be a challenge. For instance, medical cannabis, another treatment option for epilepsy, can be very costly, with some patients paying up to £2000 per month for private prescriptions[2].
• Healthcare Coverage: The availability of ethosuximide through public healthcare systems varies. In some regions, patients may have to rely on private prescriptions, which can be financially burdensome[2].

Challenges and Limitations

Despite the growth prospects, the ethosuximide market faces several challenges:

• Side Effects: Like other antiepileptic drugs, ethosuximide can have side effects, which may limit its use in some patients. Common side effects include dizziness, headache, and gastrointestinal issues[5].
• Regulatory Hurdles: Regulatory approvals and guidelines can impact the market. For example, the lack of randomized controlled trials (RCTs) for some epilepsy treatments, including medical cannabis, can limit their adoption and affect the broader antiepileptic drug market[2].

Future Outlook

The future of the ethosuximide market looks promising, driven by increasing demand and advancements in treatment:

• Research and Development: Ongoing research and development activities are expected to improve the efficacy and safety of ethosuximide and other antiepileptic drugs. This could lead to better treatment outcomes and higher market growth[3].
• Emerging Markets: The growing demand for epilepsy treatments in developing countries offers significant opportunities for market expansion. Increasing healthcare costs and the surge in various initiatives by pharmaceutical companies are expected to drive growth in these regions[3].

Key Takeaways

• The global ethosuximide market is expected to grow at a CAGR of 4% from 2024 to 2031.
• The market is driven by the increasing incidence of epilepsy, advances in treatment technology, and government funding.
• Major pharmaceutical companies play a significant role in the market, with strategies including product development and mergers and acquisitions.
• Financial costs and accessibility remain challenges, with some patients facing high costs for private prescriptions.
• Side effects and regulatory hurdles are limitations, but ongoing research and development are expected to improve treatment outcomes.

Frequently Asked Questions (FAQs)

Q: What is the primary use of ethosuximide? A: Ethosuximide is primarily used to treat absence seizures, a type of epilepsy.

Q: What is the expected growth rate of the ethosuximide market? A: The ethosuximide market is expected to grow at a CAGR of 4% from 2024 to 2031.

Q: Which regions hold the largest share in the ethosuximide market? A: North America holds a significant share due to the presence of major pharmaceutical companies and a well-developed healthcare sector.

Q: What are the major challenges facing the ethosuximide market? A: The market faces challenges such as side effects, regulatory hurdles, and high financial costs for some patients.

Q: Which companies are key players in the ethosuximide market? A: Companies such as Jazz Pharmaceuticals, Pfizer Inc., Teva Pharmaceutical Industries Ltd., AbbVie Inc., and GlaxoSmithKline plc are significant players in the market.

Cited Sources:

1. Expert Market Research - Ethosuximide Market Size, Share, Trends 2024-2032
2. BMJ Paediatrics Open - Medical cannabis for severe treatment resistant epilepsy in children
3. Verified Market Research - Childhood Absence Epilepsy Treatment Market Size And Forecast
4. Market Research Intellect - Ethosuximide Market Size and Projections
5. Neurology - Teratogenesis, Perinatal, and Neurodevelopmental Outcomes After Antiseizure Medications