Suppliers and packagers for mysoline

mysoline

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant	MYSOLINE	primidone	TABLET;ORAL	009170	NDA	Bausch Health US, LLC	66490-690-10	100 TABLET in 1 BOTTLE (66490-690-10)	2009-06-24
Valeant	MYSOLINE	primidone	TABLET;ORAL	009170	NDA	Bausch Health US, LLC	66490-691-10	100 TABLET in 1 BOTTLE (66490-691-10)	2009-06-24

Mysoline (Primidone) API Suppliers and Patent Landscape

Last updated: February 19, 2026

This analysis details current active suppliers for the active pharmaceutical ingredient (API) mysoline (primidone), their geographic distribution, and a review of the patent landscape impacting its manufacture and market. The data identifies key manufacturers and patent expirations relevant to generic entry and ongoing market exclusivity.

Who are the Current Manufacturers of Primidone API?

The global supply chain for primidone API is concentrated among a limited number of manufacturers, primarily located in India and China. These suppliers cater to both branded and generic pharmaceutical companies.

Supplier Name	Country of Origin	Primary Market Focus	Notes
Teva Pharmaceutical Industries Ltd.	Israel	Global	Major generic drug manufacturer, likely produces API internally.
Mylan N.V.	Netherlands	Global	Now part of Viatris, a significant API producer.
Sun Pharmaceutical Industries Ltd.	India	Global	One of India's largest pharmaceutical companies, significant API export.
Dr. Reddy's Laboratories Ltd.	India	Global	Major Indian API manufacturer with a global distribution network.
Zydus Lifesciences Ltd.	India	Global	Indian pharmaceutical company with established API production capacity.
CSPC Pharmaceutical Group Limited	China	Global	Large Chinese pharmaceutical group with API manufacturing capabilities.
HEC Pharm	China	Global	Chinese pharmaceutical company involved in API production.

These companies generally operate under Good Manufacturing Practices (GMP) standards recognized by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What is the Patent Status for Primidone?

The original patents protecting primidone have long expired. However, the patent landscape can involve secondary patents related to novel synthesis routes, specific polymorphic forms, or improved formulations.

Key Patent Expirations

• Original Composition of Matter Patent: The foundational patent for primidone, protecting the molecule itself, expired decades ago. This has allowed for the development and sale of generic versions of the drug.
• Process Patents: Numerous patents have been filed over the years claiming specific methods of synthesizing primidone. The expiration of these process patents can open avenues for alternative, potentially more cost-effective manufacturing routes. For example, patents related to improved purification techniques or higher yield synthesis methods.
• Polymorph Patents: In some cases, specific crystalline forms (polymorphs) of an API can be patented. While less common for older molecules like primidone, if a novel, more stable, or bioavailable polymorph were discovered and patented, it could extend market exclusivity for a specific product.

As of current analysis, there are no primary composition of matter patents actively blocking generic primidone. The focus for ongoing patent activity would typically be on manufacturing processes or specific therapeutic uses if new indications were discovered and patented.

Example of a Primidone Synthesis Process Patent (Hypothetical Structure):

A hypothetical patent filing might describe a new catalytic hydrogenation process to reduce an intermediate. The patent would detail:

• Reactants: Specific starting materials and catalysts.
• Reaction Conditions: Temperature, pressure, solvent.
• Yield and Purity: Claimed improvements over existing methods.
• Environmental Impact: Potentially reduced waste or use of greener solvents.

The expiration date of such a process patent would dictate when competitors could legally adopt that specific manufacturing method without infringement.

Current Patent Filings and Trends

A review of recent patent filings (e.g., in USPTO, EPO databases) related to primidone primarily indicates:

1. Process Optimization: Companies continue to explore and patent incremental improvements in synthesis efficiency, cost reduction, and environmental sustainability of primidone manufacturing.
2. Formulation Development: While less frequent for a mature drug, some filings may relate to novel drug delivery systems or improved formulations for enhanced patient compliance or therapeutic effect.
3. Analytical Methods: Patents for novel analytical techniques for quality control and impurity profiling of primidone API can also emerge.

Companies seeking to enter the primidone market must conduct thorough Freedom to Operate (FTO) searches to ensure their manufacturing processes and product formulations do not infringe on any existing, active patents.

What are the Regulatory Considerations for Primidone API?

The manufacturing and sale of primidone API are subject to stringent regulatory oversight by health authorities worldwide.

Key Regulatory Bodies and Requirements

• U.S. Food and Drug Administration (FDA): Manufacturers supplying the U.S. market must comply with current Good Manufacturing Practices (cGMP). This includes submitting Drug Master Files (DMFs) that detail the manufacturing process, quality controls, and stability data for the API.
• European Medicines Agency (EMA): Similar to the FDA, the EMA requires API manufacturers to adhere to EU GMP guidelines. Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are often used to demonstrate compliance.
• Other National Regulatory Authorities: Agencies in countries like Japan (PMDA), Canada (Health Canada), and Australia (TGA) have their own specific requirements.
• Pharmacopoeial Standards: Primidone API must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These monographs define identity, purity, assay, and impurity limits.

Impurity Profiling

A critical aspect of regulatory compliance for any API, including primidone, is rigorous impurity profiling. Manufacturers must identify, quantify, and control process-related impurities and degradation products. Regulatory bodies set strict limits for known and unknown impurities based on toxicological assessments. Any new synthesis route or significant change in manufacturing conditions requires revalidation of the impurity profile.

Supply Chain Security and Traceability

Increasingly, regulatory agencies emphasize supply chain integrity and traceability. API manufacturers are expected to have robust systems in place to track raw materials, intermediates, and the final API, ensuring product authenticity and preventing counterfeiting.

What is the Market Outlook for Primidone API?

The market for primidone API is driven by the demand for the finished pharmaceutical product, primarily used for treating epilepsy and certain movement disorders like essential tremor.

Market Drivers

• Prevalence of Epilepsy and Tremor Disorders: The continued incidence of these neurological conditions sustains demand.
• Generic Competition: The availability of generic primidone formulations makes the treatment accessible and drives volume demand for API.
• Cost-Effectiveness: Primidone remains a relatively cost-effective treatment option compared to some newer antiepileptic drugs.

Market Challenges

• Competition from Newer Drugs: The development of newer antiepileptic drugs with potentially better efficacy or side-effect profiles can gradually erode primidone's market share in specific patient populations.
• Regulatory Hurdles: Stringent GMP and quality requirements can be a barrier to entry for new API manufacturers.
• Price Pressures: Generic competition often leads to intense price pressure on API manufacturers, requiring efficient and low-cost production processes.

Supply Chain Dynamics

The concentration of API suppliers, particularly in Asia, presents both opportunities and risks. Geopolitical factors, trade disputes, or disruptions in major manufacturing regions can impact global supply availability and pricing. Companies relying on primidone API often diversify their supplier base to mitigate these risks.

Key Takeaways

• The supply of primidone API is primarily concentrated among manufacturers in India and China, with established global players like Teva and Viatris also participating.
• Original patents for primidone have expired, enabling generic competition. Ongoing patent activity focuses on process improvements and potential formulation advancements.
• Regulatory compliance, including adherence to cGMP and pharmacopoeial standards, is critical for API suppliers. Robust impurity profiling and supply chain traceability are essential.
• The primidone API market is stable, driven by the prevalence of neurological conditions, but faces competition from newer therapeutic agents and significant price pressures inherent in the generics market.

Frequently Asked Questions

1. Are there any active patents that prevent the manufacturing of generic primidone? No, the primary composition of matter patents for primidone have expired, allowing for generic manufacturing. However, companies must ensure their specific synthesis processes do not infringe on existing, active process patents.
2. What are the main regions where primidone API is manufactured? The majority of primidone API manufacturing is concentrated in India and China.
3. What regulatory bodies oversee primidone API production? Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national health authorities in other major markets.
4. What are the critical quality attributes for primidone API? Critical quality attributes include identity, purity (assay), control of impurities (both known and unknown), residual solvents, and physical characteristics (e.g., particle size if relevant to formulation).
5. How does the patent landscape affect pricing of primidone API? While expired composition patents enable generic competition, patented, more efficient, or environmentally friendly synthesis routes, or patented polymorphic forms, could theoretically influence cost and exclusivity if adopted by specific manufacturers. However, for a mature molecule like primidone, price is largely driven by manufacturing efficiency and market competition.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files: The FDA's Drug Master File: What It Is and How It Works. Retrieved from [FDA website, specific URL if available, or general pathway]

[2] European Medicines Agency. (n.d.). Active substance master file procedure. Retrieved from [EMA website, specific URL if available, or general pathway]

[3] United States Pharmacopeia. (n.d.). Primidone monograph. (Access requires subscription to USP-NF).

[4] European Pharmacopoeia. (n.d.). Primidone monograph. (Access requires subscription to Ph. Eur.).