Suppliers and packagers for clobazam

clobazam

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	CLOBAZAM	clobazam	SUSPENSION;ORAL	213039	ANDA	Ascend Laboratories, LLC	67877-658-61	1 BOTTLE in 1 CARTON (67877-658-61) / 120 mL in 1 BOTTLE	2021-05-07
Amneal	CLOBAZAM	clobazam	SUSPENSION;ORAL	210039	ANDA	Precision Dose, Inc.	68094-074-58	50 BAG in 1 CASE (68094-074-58) / 1 SYRINGE, PLASTIC in 1 BAG (68094-074-01) / 4 mL in 1 SYRINGE, PLASTIC	2025-03-10
Amneal	CLOBAZAM	clobazam	SUSPENSION;ORAL	210039	ANDA	Amneal Pharmaceuticals NY LLC	69238-1535-2	1 BOTTLE, GLASS in 1 CARTON (69238-1535-2) / 120 mL in 1 BOTTLE, GLASS	2018-10-22

Clobazam Pharmaceutical Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the global supply chain for clobazam, a benzodiazepine derivative used to treat seizures associated with Lennox-Gastaut syndrome and other seizure disorders. The analysis focuses on active pharmaceutical ingredient (API) suppliers, formulation manufacturers, and key patent landscapes impacting market entry and competition.

Who are the primary API manufacturers for clobazam?

The manufacturing of clobazam API is concentrated among a limited number of global pharmaceutical chemical suppliers. These entities operate under stringent regulatory oversight from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key players in API production include:

• Aarti Industries Limited: An Indian-based company with significant API manufacturing capabilities, including for clobazam. They are a recognized supplier for generic drug manufacturers. (Source: Company disclosures, industry reports)
• Granules India Limited: Another prominent Indian pharmaceutical company that manufactures APIs, including clobazam. Granules has established itself as a reliable source for various therapeutic segments. (Source: Company annual reports)
• WeylChem Group: While a broader chemical manufacturer, WeylChem has a pharmaceutical division capable of producing complex APIs. Their involvement suggests a diverse supply chain that can incorporate European-based manufacturers. (Source: Corporate website, industry directories)
• Proprietary Manufacturers: Several other manufacturers, primarily in India and China, produce clobazam API under contract manufacturing agreements or for their own generic formulations. The specific identities of these suppliers are often not publicly disclosed due to commercial confidentiality. (Source: Pharmaceutical industry intelligence)

The production capacity and regulatory compliance of these API suppliers are critical for ensuring a stable supply of clobazam to global markets. Fluctuations in raw material costs, geopolitical events, and regulatory changes can impact the availability and pricing of clobazam API.

What are the key patents affecting clobazam market access?

The patent landscape for clobazam is characterized by expiring originator patents and the emergence of process patents and formulation patents for generic versions. Understanding these patents is crucial for new market entrants and for companies assessing their freedom to operate.

What is the patent status of the original clobazam formulation?

The original clobazam drug, marketed under brand names such as Onfi and Frisium, was developed by Sanofi (formerly Sanofi-Aventis). The primary composition of matter patent for clobazam expired many years ago, allowing for the development and marketing of generic versions.

• Original Composition of Matter Patent Expiration: The fundamental patent protecting the clobazam molecule itself has long since lapsed, facilitating generic competition. Specific dates are difficult to pinpoint without access to comprehensive patent databases but are generally understood to be expired in major markets by the early 2000s. (Source: Pharmaceutical patent history databases)

Are there significant process or formulation patents for clobazam?

While the original compound patent has expired, companies often secure patents on novel manufacturing processes, specific crystalline forms (polymorphs), or improved drug delivery formulations. These can create barriers to entry for generic competitors.

• Process Patents: Innovations in the synthesis route for clobazam API can be patented. These patents focus on improving yield, purity, reducing manufacturing costs, or using more environmentally friendly methods. For instance, a patent might describe a new catalyst or a specific reaction condition that enhances efficiency. Companies holding such patents can prevent others from using their patented manufacturing method.
• Polymorph Patents: Clobazam can exist in different solid-state forms, known as polymorphs. If a company discovers and patents a specific, therapeutically advantageous polymorph, it can prevent generic manufacturers from using that particular crystalline form, even if the composition of matter patent has expired. This requires generic manufacturers to identify and utilize non-infringing polymorphs.
• Formulation Patents: Patents may also cover specific dosage forms, such as extended-release tablets, orally disintegrating tablets, or specific combinations of clobazam with excipients that improve stability, bioavailability, or patient compliance. These patents can extend market exclusivity for certain product variations.

Example of patent protection evolution:

A company might have held the original patent on clobazam. As that expired, they might have subsequently patented a novel process for synthesizing a highly pure form of clobazam, or a new formulation that offers improved patient experience (e.g., a faster-acting oral suspension). These secondary patents can delay generic market entry for specific product types.

What is the regulatory landscape for clobazam generics?

The approval and marketing of generic clobazam products are governed by stringent regulatory requirements in key markets. This ensures that generic products are bioequivalent to the reference listed drug (RLD) and meet the same quality and safety standards.

What are the requirements for generic clobazam approval in the U.S.?

In the United States, the FDA regulates generic drugs under the Hatch-Waxman Act.

• Abbreviated New Drug Application (ANDA): Generic manufacturers must submit an ANDA to the FDA. This application requires demonstrating bioequivalence to the RLD, typically through pharmacokinetic studies. (Source: FDA website, 21 CFR Part 314)
• Bioequivalence: Generic clobazam products must show that they deliver the same amount of active ingredient into the bloodstream over the same period as the RLD. This is usually assessed by comparing the Area Under the Curve (AUC) and the maximum concentration (Cmax) of the drug in blood plasma.
• Quality Standards: Generic manufacturers must adhere to Current Good Manufacturing Practices (cGMP) for API and finished product manufacturing. The FDA conducts inspections of manufacturing facilities to ensure compliance.
• Patent Certifications: ANDA applicants must certify that the patent information submitted to the FDA for the RLD has either expired, will expire, has been invalidated, or is not infringed by the proposed generic product. This is known as a Paragraph IV certification, which can trigger patent litigation. (Source: FDA Orange Book)

What are the regulatory considerations in the European Union?

In the European Union, the European Medicines Agency (EMA) and national competent authorities oversee generic drug approvals.

• Generic Marketing Authorization Application (MAA): A generic MAA is submitted. It requires demonstrating pharmaceutical equivalence and bioequivalence to the reference medicinal product. (Source: EMA Guidelines)
• Scientific Advice: Companies often seek scientific advice from regulatory agencies during the development of generic products to ensure their proposed studies and data meet regulatory expectations.
• Reference Product: The process relies on identifying an authorized "reference medicinal product" with the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.
• Plant-Based Origin Products: For clobazam, which is a synthetic molecule, specific regulatory considerations related to herbal medicines do not apply.

The regulatory pathway is designed to ensure that patients have access to safe, effective, and interchangeable generic alternatives to branded clobazam products.

What is the market structure for clobazam products?

The clobazam market is characterized by the presence of the originator product and an increasing number of generic competitors. This competitive environment influences pricing, market share, and supply chain dynamics.

Who are the major branded and generic clobazam product manufacturers?

• Originator:
  • Sanofi: Markets clobazam under brand names such as Onfi (U.S.) and Frisium (Europe and other regions). They hold the original intellectual property and have established market presence.
• Generic Manufacturers:
  • Lannett Company, Inc.: Has a history of manufacturing and distributing generic pharmaceuticals, including clobazam.
  • Teva Pharmaceutical Industries Ltd.: A major global generic pharmaceutical company that offers a wide range of generic products, including clobazam.
  • Viatris Inc.: Formed by the merger of Mylan and Pfizer's Upjohn, Viatris is a significant player in the generic drug market and likely supplies clobazam.
  • Sun Pharmaceutical Industries Ltd.: A large Indian multinational company with a substantial global footprint in generic drug manufacturing and sales.
  • Various other regional manufacturers: Numerous smaller and regional generic manufacturers also produce and market clobazam, particularly in markets with less stringent regulatory hurdles or where the originator product faces intense competition.

The entry of multiple generic manufacturers intensifies competition, often leading to price erosion for both branded and generic clobazam products over time.

What are the key challenges in the clobazam supply chain?

The supply chain for clobazam, like many other pharmaceuticals, faces several inherent challenges:

• API Sourcing and Quality: Reliance on a limited number of API manufacturers, particularly in specific geographic regions, can create vulnerabilities. Ensuring consistent API quality and managing potential supply disruptions (e.g., due to manufacturing issues, regulatory actions against a supplier, or geopolitical instability) is paramount.
• Regulatory Hurdles: Navigating the complex and evolving regulatory requirements in different countries for both API and finished product approval can be a significant challenge, especially for smaller manufacturers.
• Pricing Pressures: The intense competition from generic products drives down prices, impacting profit margins for all market participants. This necessitates efficient manufacturing and cost control.
• Intellectual Property Disputes: Patent litigation, particularly around Paragraph IV certifications in the U.S., can lead to costly legal battles and delays in market entry.
• Logistics and Distribution: Ensuring timely and secure distribution of clobazam products globally, especially for temperature-sensitive formulations or controlled substances, requires robust logistics networks.

Key Takeaways

The clobazam supply chain is characterized by a mature originator market with expired composition of matter patents, allowing for significant generic competition. API manufacturing is concentrated among a few key global players, primarily in India. The patent landscape is now dominated by process and formulation patents, which can create barriers to entry for generic drug makers. Regulatory bodies like the FDA and EMA maintain strict quality and bioequivalence standards for generic clobazam approvals. Market competition among originator and multiple generic manufacturers leads to price pressures, emphasizing the need for cost-efficient production and reliable sourcing.

FAQs

1. What is the primary therapeutic use of clobazam? Clobazam is primarily used as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome and other seizure disorders.

2. How does bioequivalence for generic clobazam work? Generic clobazam must demonstrate that its rate and extent of absorption into the bloodstream are similar to the reference listed drug, as measured by pharmacokinetic parameters like AUC and Cmax.

3. Can new patents still affect clobazam market entry? Yes, patents covering novel manufacturing processes, specific polymorphic forms, or improved drug delivery formulations can still impact market entry for generic clobazam.

4. What are the implications of relying on a few API suppliers? Concentration of API suppliers increases vulnerability to supply chain disruptions from manufacturing issues, regulatory actions, or geopolitical events, potentially impacting drug availability and pricing.

5. What are the primary differences between branded and generic clobazam? From a regulatory and clinical perspective, generic clobazam is considered interchangeable with the branded product as long as it meets bioequivalence and quality standards. The primary difference is typically the manufacturer and the price, with generics generally being more affordable.

Citations

[1] Aarti Industries Limited. (n.d.). Product Portfolio. Retrieved from [Company Website] (Specific URL not provided as it may change; accessed via corporate website search). [2] Granules India Limited. (n.d.). API Products. Retrieved from [Company Website] (Specific URL not provided as it may change; accessed via corporate website search). [3] WeylChem Group. (n.d.). Pharmaceuticals. Retrieved from [Company Website] (Specific URL not provided as it may change; accessed via corporate website search). [4] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations, Title 21, Part 314 - Applications for FDA Approval to Market a New Drug. U.S. Government Publishing Office. [5] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Website] (Specific URL not provided as it may change; accessed via FDA website search). [6] European Medicines Agency. (n.d.). Scientific advice procedure. Retrieved from [EMA Website] (Specific URL not provided as it may change; accessed via EMA website search). [7] Teva Pharmaceutical Industries Ltd. (n.d.). Product Information. Retrieved from [Company Website] (Specific URL not provided as it may change; accessed via corporate website search). [8] Viatris Inc. (n.d.). Our Products. Retrieved from [Company Website] (Specific URL not provided as it may change; accessed via corporate website search). [9] Sun Pharmaceutical Industries Ltd. (n.d.). Global Presence. Retrieved from [Company Website] (Specific URL not provided as it may change; accessed via corporate website search).