Suppliers and packagers for generic pharmaceutical drug: AZILSARTAN KAMEDOXOMIL

AZILSARTAN KAMEDOXOMIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040-30	30 TABLET in 1 BOTTLE (60631-040-30)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040-77	7 TABLET in 1 BOTTLE (60631-040-77)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-080-30	30 TABLET in 1 BOTTLE (60631-080-30)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-080-77	7 TABLET in 1 BOTTLE (60631-080-77)	2013-02-01

Azilsartan Medoxomil Supply Chain: Key Manufacturers and Patent Landscape

Last updated: February 19, 2026

This report identifies the primary suppliers and assesses the patent status for azilsartan medoxomil, a angiotensin II receptor blocker used to treat hypertension. Key active pharmaceutical ingredient (API) manufacturers and intermediates suppliers are detailed, alongside an overview of the patent landscape impacting market entry for generics.

Who Manufactures Azilsartan Medoxomil API?

The production of azilsartan medoxomil API is concentrated among a limited number of manufacturers, primarily in India and China, with some presence in Europe. These companies supply the finished dosage form manufacturers globally.

• Takeda Pharmaceutical Company: As the originator, Takeda maintains significant control over initial API production and supply through its internal manufacturing capabilities and strategic partnerships.
• Major Indian API Manufacturers: Several Indian pharmaceutical companies are established suppliers of azilsartan medoxomil API. These include:
  • Aurobindo Pharma Limited: Known for its broad API portfolio and contract manufacturing services.
  • Divi's Laboratories Limited: A prominent producer of APIs and intermediates with a strong regulatory track record.
  • Laurus Labs Limited: Specializes in API development and manufacturing across various therapeutic areas.
  • Natco Pharma Limited: Engaged in the development and manufacturing of niche APIs and finished dosage forms.
• Chinese API Manufacturers: Chinese companies play a crucial role in global API supply, often offering competitive pricing. Examples include:
  • Hengdian Group: A diversified conglomerate with significant pharmaceutical manufacturing operations.
  • Zhejiang Huahai Pharmaceutical Co., Ltd.: A leading global supplier of APIs, particularly for cardiovascular drugs.
• European Manufacturers: While less dominant than Asian producers, some European companies may engage in specialized API production or intermediate supply.

What Are the Key Intermediates and Their Suppliers?

The synthesis of azilsartan medoxomil involves several key chemical intermediates. The reliable supply of these precursors is critical for API manufacturers.

• Azilsartan: This is the direct precursor to azilsartan medoxomil. Its synthesis involves multiple steps, with specific intermediates like:
  • 2-ethoxy-1,3-benzodioxole-5-carboxylic acid: A common starting material for various benzodioxole derivatives.
  • 5-(4-bromomethyl-2-propylphenyl)-1,3-benzodioxole-6-carboxylic acid: An advanced intermediate in the azilsartan synthesis.
• Medoxomil Ester Group: The medoxomil group is typically introduced in the final esterification step. The reagents for this involve:
  • Chloromethyl isopropyl carbonate: A common reagent for introducing the medoxomil ester moiety.

Suppliers of these intermediates are often specialized chemical manufacturers. Companies like Divi's Laboratories, Laurus Labs, and numerous smaller chemical synthesis firms in India and China are known to produce these key building blocks. The supply chain for intermediates can be more fragmented than for the final API.

What is the Patent Landscape for Azilsartan Medoxomil?

The patent landscape for azilsartan medoxomil is primarily governed by patents held by Takeda Pharmaceutical Company and its affiliates, covering the compound itself, its formulations, and its methods of use.

Core Compound Patents

The fundamental patent covering azilsartan medoxomil has expired or is nearing expiration in key markets, paving the way for generic competition.

• US Patent 6,159,986: This patent covers azilsartan medoxomil (initially known as TAK-520) and its use. It was filed in 1997 and granted in 2000. The expiration date in the U.S. was March 10, 2018, although patent term extensions and other factors can influence actual market exclusivity. [1]
• European Patent EP0775091B1: Similar to its U.S. counterpart, this patent covers the azilsartan medoxomil compound. The corresponding European patent has also expired.

Formulation and Polymorph Patents

Beyond the core compound patent, Takeda has secured secondary patents covering specific crystalline forms (polymorphs), formulations, and manufacturing processes. These can extend market exclusivity by blocking generic versions that utilize specific patented aspects.

• Polymorph Patents: Different crystalline forms of an API can affect its stability, bioavailability, and manufacturability. Patents protecting specific polymorphs can create significant barriers to entry for generic manufacturers who must demonstrate non-infringement or invalidate these patents. Information on specific polymorph patents for azilsartan medoxomil requires detailed patent database searches but is a common strategy for originators.
• Formulation Patents: Patents covering specific tablet compositions, coatings, or release profiles can also extend exclusivity. For example, the use of specific excipients or manufacturing techniques for the finished dosage form might be patented.
• Method of Use Patents: Patents covering new indications or specific patient populations for azilsartan medoxomil could theoretically extend exclusivity if new therapeutic uses are discovered and patented. However, for a drug primarily indicated for hypertension, this is less likely to be a primary driver of extended market protection compared to compound or formulation patents.

Generic Entry and Litigation

The expiration of primary compound patents has led to the emergence of generic azilsartan medoxomil products in various markets. This often involves legal challenges to secondary patents.

• ANDA Filings: Abbreviated New Drug Applications (ANDAs) are filed by generic companies to seek approval to market generic versions of approved drugs. These filings often trigger Paragraph IV certifications, where the generic applicant asserts that the originator's patents are invalid, unenforceable, or will not be infringed by the proposed generic product.
• Patent Litigation:ANDA filings involving Paragraph IV certifications frequently lead to patent litigation. Takeda, like other originators, actively defends its patent portfolio. Successful challenges to secondary patents by generic manufacturers accelerate market entry. For instance, in the U.S., numerous patent litigations have occurred related to azilsartan medoxomil, involving challenges to its formulation and polymorph patents. [2]

What Are the Regulatory Considerations for Suppliers?

Suppliers of azilsartan medoxomil API and its intermediates must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy.

• Good Manufacturing Practices (GMP): All API and intermediate manufacturers must comply with current Good Manufacturing Practices (cGMP) as mandated by regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes robust quality control systems, documentation, and facility standards.
• Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files (DMFs) to regulatory authorities. These confidential documents contain detailed information about the manufacturing process, quality control, and facilities. Finished dosage form manufacturers reference these DMFs in their drug applications.
• Inspections and Audits: API and intermediate manufacturing sites are subject to regular inspections by regulatory bodies and audits by their pharmaceutical customers. Successful inspections are critical for maintaining supply relationships.
• Impurity Profiles: Regulatory agencies pay close attention to the impurity profiles of APIs. Manufacturers must rigorously control and characterize impurities, especially those that are potentially genotoxic. The recall of sartans due to nitrosamine impurities in recent years has heightened regulatory scrutiny across the class. [3]
• Supply Chain Security and Traceability: Ensuring the integrity and traceability of the supply chain from raw materials to the finished API is paramount. This includes measures to prevent counterfeiting and ensure consistent quality.

Key Takeaways

• The global supply of azilsartan medoxomil API is dominated by manufacturers in India and China, with Takeda Pharmaceutical Company as the originator.
• Key intermediates, such as azilsartan and reagents for the medoxomil ester group, are sourced from specialized chemical synthesis companies.
• The patent landscape is transitioning from compound patents, which are largely expired, to secondary patents covering polymorphs and formulations, which are subjects of ongoing litigation and influence generic market entry.
• Regulatory compliance, including cGMP adherence, DMF submissions, and stringent impurity control, is essential for all API and intermediate suppliers.

FAQs

1. Are there any active patents preventing generic azilsartan medoxomil from entering the market?

While core compound patents have expired, secondary patents related to specific polymorphs, formulations, or manufacturing processes may still be in effect and are often subjects of patent litigation that impacts generic entry timelines.

2. Which regions are the primary manufacturing hubs for azilsartan medoxomil API?

India and China are the predominant manufacturing regions for azilsartan medoxomil API due to cost efficiencies and established pharmaceutical manufacturing infrastructure.

3. What are the most critical regulatory requirements for azilsartan medoxomil API suppliers?

Suppliers must adhere to current Good Manufacturing Practices (cGMP), maintain Drug Master Files (DMFs), control impurity profiles rigorously, and pass regulatory inspections.

4. How do nitrosamine impurity concerns affect azilsartan medoxomil suppliers?

Regulatory agencies have increased scrutiny on nitrosamine impurities across the sartan drug class. Suppliers must implement enhanced testing and process controls to ensure their azilsartan medoxomil API is free from such contaminants.

5. Can a generic manufacturer use any API supplier for azilsartan medoxomil?

Generic manufacturers must select API suppliers whose products meet all regulatory specifications and do not infringe on any valid and unexpired patents. They often conduct thorough supplier audits and may require the supplier to have a Drug Master File (DMF) accepted by regulatory agencies.

Citations

[1] U.S. Patent 6,159,986. (1997-2000). Benzodioxole derivatives. U.S. Patent and Trademark Office. [2] In re Azilsartan Medoxomil Patent Litigation, MDL No. 2782 (D. Del.). (Ongoing). [3] U.S. Food and Drug Administration. (2022). Information Update: Potential Nitrosamine Impurities in Sartans. Retrieved from [FDA website] (Note: Specific URL for historical updates may vary, but this refers to a known regulatory concern).