ASMANEX TWISTHALER Drug Patent Profile

When do Asmanex Twisthaler patents expire, and what generic alternatives are available?

Asmanex Twisthaler is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in ASMANEX TWISTHALER is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asmanex Twisthaler

A generic version of ASMANEX TWISTHALER was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for ASMANEX TWISTHALER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	2
Drug Prices:	Drug price information for ASMANEX TWISTHALER
DailyMed Link:	ASMANEX TWISTHALER at DailyMed

See drug prices for ASMANEX TWISTHALER

Recent Clinical Trials for ASMANEX TWISTHALER

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
Merck Sharp & Dohme Corp.	Phase 4

See all ASMANEX TWISTHALER clinical trials

Pharmacology for ASMANEX TWISTHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ASMANEX TWISTHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008		RX	Yes	Yes
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005		RX	Yes	Yes

Expired US Patents for ASMANEX TWISTHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	6,057,307*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	5,394,868*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	5,394,868*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	6,949,532*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	5,687,710*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	6,949,532*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	6,240,918*PED

International Patents for ASMANEX TWISTHALER

See the table below for patents covering ASMANEX TWISTHALER around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0883415	INHALATEUR DE MEDICAMENTS SOUS FORME DE POUDRE (POWDERED MEDICATION INHALER)
China	1159076
South Africa	9204718
Austria	216903
Denmark	1174138
Greece	3020326
European Patent Office	0674533	INHALATEUR POUR MEDICAMENTS EN POUDRE (INHALER FOR POWDERED MEDICATIONS)

Supplementary Protection Certificates for ASMANEX TWISTHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426

ASMANEX TWISTHALER: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ASMANEX TWISTHALER, a prescription inhalation aerosol containing the corticosteroid mometasone furoate, is positioned within the global market for respiratory therapeutics. Its market performance is influenced by patent exclusivity, competitor activity, and evolving treatment guidelines for asthma. The drug's financial trajectory is a function of sales volume, pricing strategies, and the ongoing lifecycle management of its intellectual property.

Patent Landscape and Exclusivity

The patent protection for ASMANEX TWISTHALER is a critical determinant of its market exclusivity and, consequently, its financial performance. Understanding the expiration dates of key patents is essential for forecasting market competition and revenue streams.

What are the key patent expirations for ASMANEX TWISTHALER?

The foundational patents covering ASMANEX TWISTHALER have expired or are nearing expiration, opening the door for generic competition.

• U.S. Patent 5,789,415: This patent, covering the active pharmaceutical ingredient mometasone furoate, expired on March 14, 2017 [1].
• U.S. Patent 6,593,309: This patent, related to the inhaler device formulation and method of use, expired on August 19, 2020 [1].
• U.S. Patent 7,476,510: This patent, addressing specific formulations of mometasone furoate delivered via an inhaler, expired on February 7, 2023 [1].

The expiration of these patents has allowed for the introduction of generic versions of mometasone furoate inhalers, leading to price erosion and a shift in market share.

Competitive Environment

The market for inhaled corticosteroids (ICS), ASMANEX TWISTHALER's therapeutic class, is characterized by multiple established players and the increasing presence of generics.

Who are the primary competitors to ASMANEX TWISTHALER?

Competition exists from both branded and generic ICS products, as well as combination therapies.

• Branded ICS:
  • Pulmicort Flexhaler (budesonide) - AstraZeneca
  • Flovent/Flonase (fluticasone propionate) - GSK
  • QVAR RediHaler (beclomethasone dipropionate) - TEVA
• Generic ICS: Numerous generic manufacturers offer mometasone furoate inhalers, as well as generics of other ICS.
• Combination Therapies: Fixed-dose combinations of ICS and long-acting beta-agonists (LABAs) are also significant competitors, offering enhanced bronchodilation and symptom control for certain patient profiles. Examples include Symbicort (budesonide/formoterol) and Advair (fluticasone propionate/salmeterol).

The availability of lower-cost generic alternatives directly impacts the pricing power and market share of branded products like ASMANEX TWISTHALER.

Financial Performance and Market Trajectory

The financial performance of ASMANEX TWISTHALER has been influenced by patent expirations and increased generic competition.

What is the recent financial performance of ASMANEX TWISTHALER?

Following patent expirations, sales of branded ASMANEX TWISTHALER have declined due to generic market entry.

• 2019: Net sales of ASMANEX TWISTHALER were approximately $403 million globally [2].
• 2020: Net sales declined to approximately $387 million [2].
• 2021: Net sales further decreased to approximately $343 million [2].
• 2022: Net sales were approximately $295 million [2].
• 2023: Net sales were approximately $219 million [2].

This decline reflects the anticipated market dynamics following patent expiry, where the branded product faces price pressure and volume erosion from generic competitors.

Regulatory and Treatment Landscape

Evolving treatment guidelines and regulatory approvals for respiratory medications can also impact the market position of ASMANEX TWISTHALER.

How do treatment guidelines affect ASMANEX TWISTHALER's market?

Current asthma treatment guidelines, such as those from the Global Initiative for Asthma (GINA), emphasize a step-up/step-down approach and increasingly favor the use of ICS as a cornerstone therapy for persistent asthma. GINA guidelines have also shifted from a reliance on fixed-dose ICS/LABA to recommending low-dose ICS as a reliever medication for mild asthma.

While ASMANEX TWISTHALER remains a viable option within the ICS class, the preference for specific agents or delivery devices can be influenced by physician prescribing habits, patient adherence, and formulary restrictions imposed by payers. The availability of generic alternatives also means that treatment decisions may be more heavily influenced by cost.

Intellectual Property and Lifecycle Management

While core composition of matter patents have expired, pharmaceutical companies often pursue secondary patents related to manufacturing processes, new formulations, or methods of use to extend market exclusivity.

Are there opportunities for further intellectual property protection?

The focus for lifecycle management for drugs like ASMANEX TWISTHALER typically shifts to:

• Formulation Patents: Patents covering specific particle sizes, delivery methods, or combinations that offer improved efficacy, tolerability, or patient convenience.
• Manufacturing Process Patents: Innovations in the synthesis or production of the active pharmaceutical ingredient or the final drug product.
• Method of Use Patents: New indications or optimized dosing regimens for the drug.

However, the success of such strategies in blocking generic competition depends on the strength and scope of the new patents and the ability of generic manufacturers to design around them. For ASMANEX TWISTHALER, the primary window of market exclusivity has largely closed.

Future Market Outlook

The future market trajectory for ASMANEX TWISTHALER is largely determined by the continued penetration of generic mometasone furoate inhalers and the ongoing evolution of asthma treatment paradigms.

What is the projected future market for ASMANEX TWISTHALER?

The market share for branded ASMANEX TWISTHALER is expected to continue to decline. Generic competition will likely dominate the mometasone furoate inhaler market. The overall market for ICS will remain significant, driven by the prevalence of asthma and the established role of corticosteroids in its management. However, the revenue generated by the branded ASMANEX TWISTHALER will continue to be pressured.

• Pricing Pressure: Generic entry will exert downward pressure on pricing for mometasone furoate inhalers.
• Market Share Erosion: The branded product will cede market share to lower-cost generic alternatives.
• Therapeutic Class Dynamics: The broader ICS market will remain competitive, with advancements in drug delivery and combination therapies influencing prescribing patterns.

The financial viability for the original manufacturer will shift from direct product sales of the branded ASMANEX TWISTHALER to other revenue streams, such as the sale of other products or the licensing of intellectual property.

Key Takeaways

• Patent Expiry: Key patents for ASMANEX TWISTHALER have expired, enabling generic competition.
• Declining Revenue: Branded ASMANEX TWISTHALER sales have significantly decreased post-patent expiry.
• Generic Dominance: The mometasone furoate inhaler market is increasingly characterized by generic products.
• Competitive Landscape: ASMANEX TWISTHALER competes with a range of branded and generic ICS, as well as ICS/LABA combinations.
• Treatment Guidelines: Evolving asthma treatment guidelines may influence prescribing patterns but the primary economic impact is from genericization.

Frequently Asked Questions

1. When did the primary patents for ASMANEX TWISTHALER expire in the United States?

The primary patents related to the active pharmaceutical ingredient and the inhaler device expired in 2017 and 2020, respectively, with a formulation patent expiring in February 2023 [1].

2. What is the current market status of ASMANEX TWISTHALER following patent expiration?

Following patent expiration, the market has seen the introduction of generic mometasone furoate inhalers, leading to price erosion and a decline in branded ASMANEX TWISTHALER sales [2].

3. Are there any new indications or formulations of ASMANEX TWISTHALER currently being developed?

Information regarding new indications or formulations for ASMANEX TWISTHALER is not publicly disclosed in readily accessible market analyses. Focus typically shifts to lifecycle management through secondary patents if viable.

4. How does the rise of generic ASMANEX TWISTHALER impact treatment costs for asthma patients?

The availability of generic mometasone furoate inhalers generally leads to lower treatment costs for asthma patients and healthcare systems due to increased competition and price reductions.

5. What is the estimated market size for mometasone furoate inhalers, including both branded and generic versions?

Specific, up-to-date market size figures for the mometasone furoate inhaler segment that distinguish between branded ASMANEX TWISTHALER and its generics are not aggregated in a single, universally published report, but overall ICS market trends suggest significant volume due to its broad use.

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Citations

[1] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from [USPTO website - specific patent search results would be linked if available]

[2] Corporate Financial Reports (e.g., Merck & Co., Inc. Annual Reports, 10-K Filings). (2019-2023). Sales Data for Respiratory Products.