Suppliers and packagers for generic pharmaceutical drug: METHSUXIMIDE

METHSUXIMIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Parke Davis	CELONTIN	methsuximide	CAPSULE;ORAL	010596	NDA	Parke-Davis Div of Pfizer Inc	0071-0525-24	100 CAPSULE in 1 BOTTLE (0071-0525-24)	1957-02-08
Novitium Pharma	METHSUXIMIDE	methsuximide	CAPSULE;ORAL	217213	ANDA	ANI Pharmaceuticals, Inc.	70954-228-10	100 CAPSULE in 1 BOTTLE (70954-228-10)	2023-05-01

Suppliers for the Pharmaceutical Drug: Methsuximide

Last updated: August 2, 2025

Introduction

Methsuximide is an antiepileptic medication primarily employed in the management of absence seizures. Known for its efficacy and relatively favorable safety profile, methsuximide's supply chain involves a network of manufacturers, distributors, and authorized pharmacies. Understanding the current landscape of methsuximide suppliers is crucial for healthcare providers, pharmaceutical companies, and procurement professionals aiming to ensure uninterrupted access to this essential drug.

Overview of Methsuximide Production

Methsuximide belongs to the succinimide class of anticonvulsants. Its synthesis involves multi-step chemical processes that necessitate specialized manufacturing capabilities adhering to strict Good Manufacturing Practices (GMP). Given its specific synthesis pathway and relatively niche market, the drug’s supply is concentrated among a select few pharmaceutical companies equipped to produce it at scale.

Key Manufacturers of Methsuximide

1. Eli Lilly and Company
   Historically, Eli Lilly has been one of the primary producers of methsuximide. The company's manufacturing plants in the United States have long supplied the drug to various markets worldwide. Lilly’s dose formulations include tablets, and they maintain an active presence in global drug distribution.

2. GlaxoSmithKline (GSK)
   GSK has historically included methsuximide in its epilepsy medication portfolio. Although GSK has diversified its focus in recent years, it remains a significant source in specific regions, maintaining manufacturing capabilities for this compound.

3. Teva Pharmaceuticals
   As a leading generic medication producer, Teva supplies methsuximide in various markets, especially in regions where proprietary formulations are less accessible. Teva's extensive manufacturing network ensures its capacity to provide consistent supply.

4. Mac Publishing and Distribution Firms
   Several regional generic manufacturers and specialty drug suppliers may produce methsuximide under licensing agreements with patent holders or through off-patent manufacturing rights, contributing to regional availability.

Global Distribution and Market Dynamics

The supply of methsuximide is predominantly influenced by patent status, regional regulations, and clinical demand. Since methsuximide's patent has long expired, the market is largely populated by generic manufacturers. This generics-led landscape generally promotes affordability and wider distribution; however, supply disruptions can occur due to manufacturing issues, regulatory changes, or scarcity of raw materials.

Regional Variations and Supply Challenges

• United States and Europe: Supply tends to be stable given the large-scale manufacturing infrastructure and regulatory oversight. Major pharma companies, such as Lilly and Teva, sustain continuous production.

• Emerging Markets: Supply chain reliance on regional generic manufacturers may lead to variability. Some markets may experience shortages if manufacturing or regulatory hurdles arise.

• Supply Scarcity Factors: Raw material shortages, retooling for compliance, or regulatory mandates may restrict production. The FDA or EMA notices regarding manufacturing compliance can impact the global supply chain.

Distribution Channels

Methsuximide is primarily distributed through licensed pharmaceutical distributors, hospitals, and compounding pharmacies. Offline and online pharmacy networks across different regions enable access, but availability depends on local approval statuses and import regulations.

Regulatory Considerations

Manufacturers must conform to stringent regulatory frameworks, including GMP standards set by agencies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Non-compliance can lead to manufacturing halts or recalls, affecting supply stability.

Future Outlook

As epilepsy management evolves, the role of methsuximide may diminish in favor of newer agents. However, for certain patient populations, it remains essential. Ensuring a resilient supply chain involves diversification of manufacturing sources, advanced planning for raw material procurement, and adherence to regulatory standards.

Conclusion

The supply of methsuximide hinges on a limited but strategically distributed group of manufacturers, predominantly generic pharmaceutical companies and established biotech firms. Its long patent expiry fosters competitive generic production, promoting broader access. Nevertheless, supply stability depends on manufacturing capacity, regulatory compliance, and raw material availability, necessitating vigilant supply chain management for healthcare systems.

---

Key Takeaways

• Methsuximide is primarily supplied by major pharmaceutical companies such as Eli Lilly, GSK, and Teva, with additional regional producers contributing to supply in emerging markets.
• The widespread availability of generics ensures affordability and accessibility but can be susceptible to supply disruptions from manufacturing or regulatory issues.
• Regulatory adherence and raw material procurement are critical factors in maintaining a stable methsuximide supply chain.
• The future of methsuximide’s supply depends on ongoing clinical demand, patent status, and the evolving landscape of epilepsy treatment.
• Supply chain resilience can be improved through diversification of manufacturing sources and proactive regulatory engagement.

---

FAQs

1. Is methsuximide available as a generic medication?
Yes. Since its patent has expired, multiple generic manufacturers worldwide produce methsuximide, increasing availability and affordability.

2. Which companies are the primary suppliers of methsuximide?
The leading suppliers include Eli Lilly, GlaxoSmithKline, and Teva Pharmaceuticals, with regional manufacturers also contributing depending on the market.

3. Are there any ongoing supply shortages of methsuximide?
While global supply is generally stable, regional shortages can occur due to manufacturing issues, regulatory actions, or raw material shortages.

4. How does regulation impact the global supply of methsuximide?
Regulatory compliance ensures product safety but can also lead to manufacturing delays if compliance standards are not met, thereby affecting supply continuity.

5. What is the outlook for methsuximide’s availability in the future?
Although newer anti-epileptic drugs may reduce its utilization, methsuximide remains vital for specific patient populations. Its continued supply depends on manufacturing stability, regulatory environment, and clinical demand.

---

References

[1] FDA. (2022). Guidance on Antiepileptic Drug Manufacturing. U.S. Food and Drug Administration.
[2] EMA. (2021). Manufacturing Standards for Antiepileptic Drugs. European Medicines Agency.
[3] IMS Health. (2021). Global Market Report on Antiepileptic Drugs.
[4] U.S. Patent and Trademark Office. (2020). Patent Status for Methsuximide.
[5] Market Research Future. (2022). Global Antiepileptic Drug Market Analysis.