Primidone - Generic Drug Details

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

Primidone is the generic ingredient in two branded drugs marketed by Fhta, Valeant, Amneal Pharm, Anda Repository, Carnegie, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, Rubicon, and Watson Labs, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for primidone. Twenty-one suppliers are listed for this compound.

Summary for primidone

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	24
Patent Applications:	6,464
Drug Prices:	Drug price trends for primidone
Drug Sales Revenues:	Drug sales revenues for primidone
What excipients (inactive ingredients) are in primidone?	primidone excipients list
DailyMed Link:	primidone at DailyMed

See drug prices for primidone

See drug sales revenues for primidone

Recent Clinical Trials for primidone

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

Sponsor	Phase
Simbec Orion	Phase 2
KABS laboratories	Phase 2
Dr. Jurjan Aman	Phase 2

See all primidone clinical trials

Pharmacology for primidone

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

Medical Subject Heading (MeSH) Categories for primidone

Anticonvulsants

Anatomical Therapeutic Chemical (ATC) Classes for primidone

N03AA	Barbiturates and derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for primidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	PRIMIDONE	primidone	TABLET;ORAL	040717-002	Feb 12, 2008		DISCN	No	No
Impax Labs	PRIMIDONE	primidone	TABLET;ORAL	040717-001	Feb 12, 2008		DISCN	No	No
Amneal Pharm	PRIMIDONE	primidone	TABLET;ORAL	040866-001	Apr 23, 2008	AB	RX	No	No
Rubicon	PRIMIDONE	primidone	TABLET;ORAL	214896-003	Dec 28, 2022		RX	No	No
Hikma Intl Pharms	PRIMIDONE	primidone	TABLET;ORAL	040667-002	Jul 27, 2006		DISCN	No	No

Primidone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Primidone

Introduction

Primidone, a barbiturate derivative, is widely used in the treatment of epilepsy and other seizure disorders. Understanding the market dynamics and financial trajectory of primidone is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

The global primidone market is influenced by several key factors, including production, pricing, and distribution dynamics.

Production Dynamics

The production of primidone is affected by the availability of raw materials, manufacturing costs, and regulatory compliance. Companies involved in the production of primidone must navigate these factors to maintain a stable supply chain. For instance, fluctuations in the cost of raw materials can significantly impact the production costs and subsequently the pricing of the drug[1].

Pricing Dynamics

Pricing is a critical aspect of the primidone market. The cost of primidone can vary based on geographical location, market competition, and regulatory policies. In regions with stringent price controls, the pricing of primidone may be capped, affecting the profitability of pharmaceutical companies. Conversely, in markets with less regulation, companies may have more flexibility in setting prices[4].

Distribution Dynamics

The distribution of primidone involves a complex network of wholesalers, retailers, and healthcare providers. Effective distribution strategies are essential to ensure that the drug reaches patients in a timely and efficient manner. Factors such as logistics, storage, and inventory management play significant roles in this process[1].

Financial Trajectory

The financial performance of the primidone market can be analyzed through several key indicators.

Market Size and Growth

The global primidone market is expected to exhibit steady growth driven by the increasing prevalence of epilepsy and other seizure disorders. Market reports indicate that the demand for antiepileptic drugs, including primidone, is on the rise, contributing to the overall growth of the market[4].

Revenue and Sales

Revenue from primidone sales is influenced by the volume of prescriptions, pricing strategies, and market competition. Pharmaceutical companies generating revenue from primidone must continuously monitor these factors to maintain market share and profitability.

Cost Structure

The cost structure for primidone includes research and development (R&D) expenses, manufacturing costs, marketing expenditures, and distribution costs. Companies must manage these costs effectively to ensure sustainable profitability. For example, investments in R&D can lead to improved formulations or delivery methods, potentially increasing market share and revenue[1].

Competitive Landscape

The competitive landscape of the primidone market is characterized by several key players.

Market Players

The market for primidone is fragmented, with multiple pharmaceutical companies involved in its production and distribution. Key players must differentiate themselves through innovative products, efficient distribution networks, and competitive pricing strategies to gain a competitive edge[4].

Market Share

Market share is a critical metric in the primidone market, with companies competing to capture a larger portion of the market. This competition drives innovation and can lead to better products and services for patients.

Regulatory Environment

The regulatory environment plays a significant role in shaping the market dynamics of primidone.

Regulatory Compliance

Pharmaceutical companies must comply with stringent regulatory requirements to ensure the safety and efficacy of primidone. Regulatory approvals and compliance with quality standards are essential for maintaining market presence[1].

Impact on Pricing and Distribution

Regulatory policies can significantly impact the pricing and distribution of primidone. For instance, price controls and reimbursement policies can affect the profitability of pharmaceutical companies and influence how the drug is distributed to patients.

Challenges and Opportunities

The primidone market faces several challenges and opportunities that can impact its financial trajectory.

Challenges

• Side Effects and Safety Concerns: Primidone, like other antiepileptic drugs, can have side effects that may affect patient compliance and overall market demand.
• Generic Competition: The presence of generic versions of primidone can reduce the market share of branded products, impacting revenue and profitability[4].

Opportunities

• Increasing Prevalence of Epilepsy: The rising incidence of epilepsy and other seizure disorders presents an opportunity for growth in the primidone market.
• Emerging Markets: Expanding into emerging markets where access to antiepileptic drugs is limited can provide new revenue streams for pharmaceutical companies.

Key Takeaways

• The global primidone market is driven by production, pricing, and distribution dynamics.
• The market is expected to grow due to the increasing prevalence of epilepsy and other seizure disorders.
• Regulatory compliance and competitive strategies are crucial for maintaining market share and profitability.
• Challenges such as side effects and generic competition must be addressed to ensure sustainable growth.

FAQs

1. What are the primary factors influencing the production of primidone? The primary factors include the availability of raw materials, manufacturing costs, and regulatory compliance.

2. How does the pricing of primidone vary across different regions? Pricing can vary based on geographical location, market competition, and regulatory policies. Regions with stringent price controls may have capped prices, while less regulated markets offer more flexibility in pricing.

3. What are the key challenges faced by the primidone market? Key challenges include side effects and safety concerns, as well as competition from generic versions of the drug.

4. What opportunities exist for growth in the primidone market? Opportunities include the increasing prevalence of epilepsy and other seizure disorders, as well as expanding into emerging markets.

5. How does regulatory compliance impact the primidone market? Regulatory compliance is essential for ensuring the safety and efficacy of primidone. It can also impact pricing and distribution strategies, affecting the overall profitability of pharmaceutical companies.

Sources

1. Cognitivemarketresearch.com - Primidone Market Report 2024 (Global Edition)
2. Investors.primemedicine.com - Prime Medicine Reports Full Year 2023 Financial Results and Provides Business Updates
3. PRNewswire.com - Central Nervous System (CNS) Stimulant Drugs Market size is set to grow by USD 6.48 billion from 2023-2027
4. Prof-research.com - Primidone Market Size, Share, Trend and Forecast to 2025
5. Biospace.com - Prime Medicine Reports Third Quarter 2024 Financial Results and Provides Business Updates