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-six 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	No
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	021067-002	Feb 1, 2008
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005

International Patents for ASMANEX TWISTHALER

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

Country	Patent Number	Title	Estimated Expiration
Norway	952429
Ireland	922061
Japan	3480736
European Patent Office	1174139	Utilisation du furoate de mometasone pour le traitement des affections pulmonaires et des voies respiratoires (Use of mometasone furoate for treating airway passage and lung diseases)
Hong Kong	1135331
China	1091321
Norway	306602

Supplementary Protection Certificates for ASMANEX TWISTHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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	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
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622

Market Dynamics and Financial Trajectory for ASMANEX TWISTHALER

Last updated: July 27, 2025

Introduction

ASMANEX TWISTHALER (mometasone furoate inhalation powder) is a corticosteroid-based inhaler approved for managing asthma and allergic rhinitis. Since its FDA approval and subsequent global market introduction, ASMANEX TWISTHALER has established a significant presence within the inhaled corticosteroid (ICS) segment. This comprehensive analysis explores its market dynamics, competitive positioning, revenue trajectories, and future prospects.

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Market Overview and Therapeutic Positioning

ASMANEX TWISTHALER, developed and marketed primarily by Merck & Co. (known as MSD outside the U.S. and Canada), entered a lucrative segment characterized by rising asthma prevalence globally. The inhaler’s efficacy in controlling airway inflammation positions it among the key therapies for moderate to severe asthma, alongside competitors like Flovent (fluticasone propionate), Pulmicort (budesonide), and Symbicort (budesonide/formoterol).

The global asthma therapeutics market was valued at approximately $13.7 billion in 2022, with ICS agents representing a lion's share due to their centrality in asthma management guidelines [1]. Demand drivers include increasing urbanization, pollution, and awareness efforts—factors contributing to rising diagnosis rates.

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Market Dynamics

1. Competitive Landscape

The inhaler market is highly competitive, with pharmaceutical giants leveraging extensive R&D pipelines and marketing strategies. ASMANEX TWISTHALER’s key competitors include:

• Fluticasone Propionate (Flovent): Market leader, buoyed by extensive use and brand recognition.
• Budesonide (Pulmicort): Known for its safety profile; a preferred monotherapy in pediatric populations.
• Beclomethasone (Qvar): An alternative corticosteroid inhaler with different delivery formulations.

The competitive advantage of ASMANEX lies in its unique twist mechanism, delivering precise doses and reducing deposition variability—a desirable feature for both physicians and patients. Nonetheless, patent expirations (notably of parent formulations and delivery devices) threaten market share, necessitating innovation and strategic positioning.

2. Patent Expiry and Generic Entry

The initial patents for ASMANEX TWISTHALER expired or faced challenges in key markets by around 2019-2022. Generic competitors, offering lower-cost alternatives, have entered some markets, exerting downward pressure on prices and revenues.

However, the brand still retains a premium through:

• Evidence of efficacy and safety
• Physician loyalty
• Patient preference for specific inhaler devices

Investments in new delivery technologies or fixed-dose combinations could sustain its relevance.

3. Regulatory Environment and Approvals

Regulatory landscapes influence market penetration and sales trajectories. Recent approvals for pediatric indications, as well as formulations for Allergic Rhinitis (e.g., in nasal spray forms), expand the potential addressable market.

For instance, the approval of ASMANEX in pediatric populations aged 4 years and above in several jurisdictions has bolstered usage, aligning with the rising prevalence of severe asthma among children.

4. Market Penetration and Adoption Trends

Global adoption varies significantly:

• Developed Markets: High penetration, driven by established asthma management guidelines, insurance coverage, and physician familiarity.
• Emerging Markets: Growing adoption fueled by increasing healthcare infrastructure, rising asthma awareness, and entry of generic versions.

In Asia-Pacific, for example, the asthma therapeutics market is projected to grow at a CAGR of approximately 5% through 2028, offering expansion opportunities for products like ASMANEX.

5. Pricing and Reimbursement Factors

Reimbursement policies substantially shape sales. In markets with government-funded healthcare (e.g., Europe, Canada), reimbursement rates influence patient access and prescribing patterns.

Price erosion caused by generics, alongside value-based pricing initiatives, could affect profit margins.

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Financial Trajectory and Revenue Outlook

1. Historical Financial Performance

Although specific sales data for ASMANEX TWISTHALER are proprietary, industry estimates suggest that Merck generated approximately $400-500 million annually from the inhaler segment pre-patent expiry, with ASMANEX contributing a significant share.

Post-patent expiry, revenue declines appeared; however, strategic marketing and formulation innovations have partially offset these losses.

2. Current and Projected Revenue Streams

• Inhaler Sales: Expected to stabilize in mature markets with slow declines; however, sales in emerging markets are anticipated to grow due to increased adoption.
• New Indications and Formulations: Approval for nasal sprays in allergic rhinitis could diversify revenue streams, potentially adding hundreds of millions of dollars annually.
• Fixed-Dose Combinations: Introduction of combinations with long-acting beta-agonists (LABAs), such as ASMANEX HFA/BIFEN, expands use cases and revenue opportunities.

Forecasts from industry analysts project a compound annual growth rate (CAGR) of around 2-4% for inhaled corticosteroids globally over the next five years, considering market saturation in developed nations and expansion in emerging markets [2].

3. Impact of Patent and Pricing Dynamics

Patent cliffs pressure revenues, but ongoing innovation, strategic alliances, and lifecycle management initiatives can mitigate decline. The development of low-cost alternatives and biosimilars could further influence profitability margins.

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Future Outlook and Strategic Considerations

The future for ASMANEX TWISTHALER hinges on multiple factors:

• Expansion into New Indications: Beyond asthma, conditions like allergic rhinitis and COPD offer growth vectors.
• Formulation Innovation: Transitioning to digital inhalers with tracking capabilities might enhance patient adherence and allow data-driven marketing.
• Market Penetration in Emerging Economies: Developing affordable formulations and collaborating with local healthcare systems are crucial.
• Lifecycle Management: Launching next-generation devices, fixed-dose combinations, and pediatric formulations sustains competitiveness.

Given the increasing global burden of respiratory diseases, combined with technological advancements, the market trajectory for ASMANEX is cautiously optimistic but requires strategic agility.

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Key Takeaways

• Market Position: ASMANEX TWISTHALER maintains a solid position in the inhaled corticosteroid market, underpinned by device innovation and expanding indications.
• Revenue Trends: Post-patent expiries have challenged sales, but diversification and pipeline expansion help to sustain growth.
• Competitive Risks: Patent expirations and generic competition necessitate continuous innovation and strategic marketing.
• Geographic Expansion: Growth prospects are strongest in emerging markets where asthma diagnosis and treatment escalate.
• Technological Advancements: Digital health integration and fixed-dose regimens could differentiate ASMANEX’s future offerings.

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FAQs

Q1: How has patent expiration impacted ASMANEX TWISTHALER’s market share?
A1: Patent expirations led to increased generic competition, resulting in price reductions and a slow decline in market share in key markets. However, brand loyalty and device preferences have helped sustain sales temporarily.

Q2: What are the primary growth drivers for ASMANEX in the next five years?
A2: Expansion into pediatric and allergic rhinitis indications, entry into emerging markets, and innovations in delivery device technology are primary drivers.

Q3: How does ASMANEX compare to its main competitors?
A3: While Flovent remains the market leader due to early market entry and broad use, ASMANEX offers unique device advantages and has a strong niche, especially in pediatric use and combination therapies.

Q4: What role does digital health technology play in the future of ASMANEX?
A4: Incorporating digital inhalers can improve adherence, provide real-time data to physicians, and differentiate ASMANEX in a competitive landscape, potentially boosting future revenues.

Q5: What are the risks associated with ASMANEX’s future market performance?
A5: Risks include generic price erosion, regulatory changes affecting reimbursement, competitive innovations, and shifting healthcare policies favoring cost-effective options.

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References

[1] Shields, A., et al. “Global Asthma Therapeutics Market Size & Forecast,” MarketWatch, 2022.
[2] Grand View Research. “Inhaled Corticosteroids Market Trends & Forecast,” 2022.