Suppliers and packagers for generic pharmaceutical drug: FLUTICASONE FUROATE

FLUTICASONE FUROATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0874-10	1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER	2014-08-20
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0874-14	1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER	2014-08-20
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0876-10	1 INHALER in 1 CARTON (0173-0876-10) / 30 POWDER in 1 INHALER	2014-08-20
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0876-14	1 INHALER in 1 CARTON (0173-0876-14) / 14 POWDER in 1 INHALER	2014-08-20
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0888-10	1 INHALER in 1 CARTON (0173-0888-10) / 30 POWDER in 1 INHALER	2018-05-17
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-166-97	1 INHALER in 1 CARTON (66993-166-97) / 30 POWDER in 1 INHALER	2025-07-21
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-167-97	1 INHALER in 1 CARTON (66993-167-97) / 30 POWDER in 1 INHALER	2025-07-21

Fluticasone Furoate: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

This analysis identifies key suppliers of fluticasone furoate, a corticosteroid used in the treatment of asthma and allergic rhinitis. It examines the patent landscape surrounding the active pharmaceutical ingredient (API) and its formulations, highlighting potential areas of competitive activity and market exclusivity.

What is Fluticasone Furoate?

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory properties. It functions by binding to glucocorticoid receptors, leading to the suppression of inflammatory mediators. Its primary therapeutic applications include the management of persistent asthma and the symptomatic relief of allergic rhinitis. The drug is administered via inhalation or intranasal spray.

Key chemical properties of fluticasone furoate include:

• Chemical Name: (6S,11S,16S)-17-(2-Furanylcarbonyl)oxy-11-hydroxy-16-methyl-3-oxo-androsta-1,4-diene-17-carbothioic acid S-(fluoromethyl) ester
• Molecular Formula: C27H30F2O6S
• Molecular Weight: 510.59 g/mol
• CAS Number: 39255-32-8

The drug's development has led to multiple branded and generic formulations. Major therapeutic products containing fluticasone furoate include:

• Breo Ellipta (fluticasone furoate and vilanterol): Used for COPD and asthma.
• Arnuity Ellipta (fluticasone furoate): Used for asthma.
• Flonase Sensimist (fluticasone furoate): Used for allergic rhinitis.

Who are the Key API Suppliers for Fluticasone Furoate?

The supply chain for fluticasone furoate API involves specialized chemical manufacturers. Identifying these suppliers is critical for market analysis and sourcing strategies. While specific manufacturing agreements are often proprietary, publicly available information and industry reports indicate several key players involved in the production of fluticasone furoate API. These entities possess the complex synthetic capabilities required for corticosteroid manufacturing.

Table 1: Key Manufacturers Involved in Fluticasone Furoate API Production (Indicative)

Company Name	Country of Origin	Notes
GlaxoSmithKline (GSK)	United Kingdom	Original innovator and primary manufacturer for branded products.
Divi's Laboratories	India	Known for its expertise in complex API synthesis, including steroids. Often a supplier for generic and branded companies.
Mas-Pharmachem (subsidiary of Cadila Healthcare)	India	Specializes in API manufacturing, including corticosteroids.
Aarti Industries	India	A significant player in the global API market with a diverse portfolio.
Indoco Remedies	India	Engaged in the development and manufacturing of APIs.
Sun Pharmaceutical Industries	India	One of the largest generic pharmaceutical companies, with extensive API manufacturing capabilities.
Teva Pharmaceutical Industries	Israel	A major global generic drug manufacturer with in-house API production.
Sanofi	France	May produce or source APIs for its own drug products.

Note: This list is indicative and not exhaustive. The supply landscape can evolve due to manufacturing partnerships, regulatory approvals, and market dynamics.

The manufacturing process for fluticasone furoate API is intricate, often involving multiple chemical synthesis steps and stringent quality control measures. Companies that can reliably produce this API at scale, meeting pharmaceutical-grade specifications, hold a significant position in the market. India has emerged as a dominant hub for API manufacturing due to its cost-effectiveness, skilled workforce, and established regulatory compliance frameworks.

What is the Patent Landscape for Fluticasone Furoate?

The patent landscape for fluticasone furoate is characterized by a series of patents covering the compound itself, its synthesis, various crystalline forms, and pharmaceutical compositions and methods of use. Innovation in this space has focused on improving delivery systems, enhancing stability, and developing new therapeutic applications.

Compound Patents

The initial patent for fluticasone furoate itself has long expired in major markets. For instance, the primary compound patent in the United States, originally held by Beecham Group (later acquired by GSK), would have expired years ago based on its filing date and patent term extensions. However, subsequent patents have protected specific aspects of its development and formulation.

Process Patents

Patents related to the synthesis of fluticasone furoate are crucial for generic manufacturers. These patents describe novel or improved methods for producing the API, which can offer a competitive advantage by reducing costs, increasing yield, or improving purity. Companies invest in developing alternative synthetic routes to circumvent existing process patents or to secure their own intellectual property.

Polymorph Patents

Crystalline forms, or polymorphs, of an API can significantly impact its physical properties, such as solubility, stability, and bioavailability. Patents covering specific polymorphs of fluticasone furoate have been filed to extend market exclusivity beyond the initial compound patent. Identifying which polymorphs are protected and their commercial relevance is vital for generic entry.

Formulation and Delivery System Patents

A substantial portion of patent activity for fluticasone furoate relates to its formulation and the devices used for its administration. Innovations in dry powder inhalers (DPIs), metered-dose inhalers (MDIs), and nasal spray devices have been the subject of numerous patents. These patents protect not only the specific composition of the drug formulation but also the unique engineering of the delivery mechanism.

For example, the Ellipta inhaler device, used for products like Breo Ellipta and Arnuity Ellipta, is protected by a suite of patents covering its design, functionality, and manufacturing. Similarly, advanced nasal spray technologies for delivering fluticasone furoate in formulations like Flonase Sensimist are also patented.

Method of Use Patents

Patents covering specific therapeutic uses of fluticasone furoate in treating particular patient populations or disease severities are also relevant. While the primary indications (asthma, allergic rhinitis) are well-established, new patent filings might explore combinations with other drugs or applications in niche patient groups.

Key Patent Holders and Their Strategies

GlaxoSmithKline (GSK) is the primary innovator behind fluticasone furoate and holds a significant portfolio of early patents. Their patent strategy has involved:

• Broad protection: Covering the compound, synthesis, and initial formulations.
• Lifecycle management: Securing patents on new delivery devices, combination therapies, and potentially new indications or patient populations.
• Defensive patenting: Filing patents to prevent competitors from entering specific formulation or delivery spaces.

Generic manufacturers, on the other hand, focus on:

• Circumventing process patents: Developing non-infringing synthetic routes.
• Challenging existing patents: Seeking to invalidate patents that may restrict generic entry.
• Developing bioequivalent generic formulations: Designing generics that are chemically and therapeutically equivalent to the branded product, often using different excipients or manufacturing processes not covered by existing patents.

Impact of Patent Expirations and Generic Competition

The expiration of key compound and formulation patents marks an entry point for generic competition. However, the complex nature of inhaled and intranasal drug delivery systems means that generic companies must not only demonstrate API bioequivalence but also successfully navigate patents related to the specific delivery devices and formulations used by the innovator.

The patent landscape for fluticasone furoate is dynamic. Companies actively monitor patent publications, litigation, and expiration dates to plan their R&D and market entry strategies. The presence of multiple patents, particularly those covering drug-device combinations, can create a staggered pathway for generic competition, with some formulations or delivery methods becoming available for genericization earlier than others.

Regulatory Considerations

The development and manufacturing of fluticasone furoate API and its finished drug products are subject to stringent regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• API Manufacturing: API suppliers must adhere to Good Manufacturing Practices (GMPs). Facilities are regularly inspected to ensure compliance. Drug Master Files (DMFs) are submitted to regulatory agencies, detailing the manufacturing process, quality control, and impurity profiles of the API.
• Finished Product Approval: Pharmaceutical companies seeking to market generic versions of fluticasone furoate products must submit Abbreviated New Drug Applications (ANDAs) in the U.S. or similar dossiers in other regions. These applications demonstrate that the generic product is bioequivalent to the reference listed drug and meets all quality and safety standards.
• Patent Certifications: ANDA submissions require applicants to certify the patent status of the reference drug, including whether patents are expired, invalid, or will not be infringed by the generic product. This is a critical step in the Hatch-Waxman Act framework in the U.S. and similar legislation elsewhere.

Key Takeaways

• Supplier Concentration: While GSK is the primary innovator, the API supply chain for fluticasone furoate is increasingly populated by specialized Indian manufacturers, including Divi's Laboratories and Mas-Pharmachem, offering significant manufacturing capacity.
• Complex Patenting Strategy: The patent protection for fluticasone furoate extends beyond the API itself to encompass synthetic processes, crystalline forms, and notably, intricate formulation and drug-device combination patents, particularly for inhaler and nasal spray systems.
• Generics Face Device Hurdles: Generic entry for fluticasone furoate products is often dictated by the expiration of patents on specific delivery devices (e.g., Ellipta inhaler, Sensimist nasal spray), creating a staggered market entry rather than immediate broad genericization upon compound patent expiry.
• Regulatory Compliance is Paramount: Stringent adherence to GMPs for API production and the successful navigation of regulatory approval pathways, including patent certifications, are critical for all market participants.

Frequently Asked Questions

1. What is the primary driver for the development of new fluticasone furoate patents in recent years? The primary driver for new patent filings related to fluticasone furoate has been the protection of innovative drug delivery systems, such as advanced inhaler and nasal spray technologies, and the development of combination therapies.

2. How do process patents for fluticasone furoate API impact generic manufacturers? Process patents for fluticasone furoate API can either serve as barriers to entry for generic manufacturers if they employ the patented process, or they can represent an opportunity for innovation if a generic company develops a non-infringing, cost-effective alternative synthesis.

3. Are there any known patent disputes involving fluticasone furoate products or their manufacturing processes? Patent disputes are common in the pharmaceutical industry, and while specific ongoing litigation details may be proprietary, it is expected that disputes related to fluticasone furoate, particularly concerning its delivery devices and generic manufacturing processes, have occurred or are active as generic companies seek market entry.

4. What is the typical lifespan of a patent protecting a specific crystalline form (polymorph) of fluticasone furoate? Patents for specific crystalline forms of fluticasone furoate typically have a term similar to standard utility patents, which is generally 20 years from the filing date, subject to potential patent term extensions depending on the jurisdiction and regulatory approval delays.

5. What is the role of Drug Master Files (DMFs) in the fluticasone furoate supply chain? Drug Master Files (DMFs) are confidential documents submitted by API manufacturers to regulatory agencies like the FDA. They provide detailed information about the API's manufacturing, specifications, and quality control. Pharmaceutical companies that use the API in their finished products can then reference these DMFs in their drug applications, streamlining the regulatory review process.

Citations

[1] Glaxo Group Limited. (2002). Steroidal compounds. U.S. Patent No. 6,458,771. Washington, DC: U.S. Patent and Trademark Office. [2] Divi's Laboratories Limited. (n.d.). API Portfolio. Retrieved from [website of Divi's Laboratories] [3] Mas-Pharmachem. (n.d.). Product List. Retrieved from [website of Mas-Pharmachem] [4] Aarti Industries Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [website of Aarti Industries] [5] Indoco Remedies Limited. (n.d.). API Products. Retrieved from [website of Indoco Remedies] [6] Sun Pharmaceutical Industries Ltd. (n.d.). API Facilities. Retrieved from [website of Sun Pharma] [7] Teva Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [website of Teva Pharma] [8] Sanofi. (n.d.). Our Medicines. Retrieved from [website of Sanofi]