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

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	5,829,434*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	8,173,172*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	6,365,581*PED

International Patents for ASMANEX TWISTHALER

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

Country	Patent Number	Title	Estimated Expiration
China	101156860
New Zealand	331361	Powder inhaler including swirl means for changing the flow direction of the powder and chimney means for reversing the flow direction
Norway	963132

Supplementary Protection Certificates for ASMANEX TWISTHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
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

Market Dynamics and Financial Trajectory for ASMANEX TWISTHALER

Overview of ASMANEX TWISTHALER

Drug Name: Mometasone Brand Name: Asmanex® Twisthaler® Type of Medicine: Inhaled corticosteroid Form: Dry powder inhaler Medicine Use: Long-term control of asthma symptoms[5].

Market Context: U.S. Asthma Drugs Market

The U.S. asthma drugs market is a significant and growing sector, driven by several key factors. As of 2023, the market was valued at USD 8.95 billion and is projected to reach USD 14.75 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 5.12% from 2024 to 2033[3].

Demand Drivers

1. Increasing Prevalence of Asthma: The rising number of asthma cases in the U.S. is a major driver of the market. With over 25 million asthmatics in the country, the demand for effective asthma management solutions is on the rise[3].

2. Advancements in Medical Research and Technology: Innovations in asthma medications, including the development of new and more potent treatments, contribute to market growth. ASMANEX TWISTHALER, as an inhaled corticosteroid, benefits from these advancements[3].

3. Rising Healthcare Expenditure: Increased healthcare spending and growing awareness about asthma management further fuel the market expansion[3].

Competitive Landscape

The U.S. asthma drugs market is highly competitive, with various pharmaceutical products aimed at alleviating symptoms and preventing exacerbations. ASMANEX TWISTHALER, as a long-term control medication, competes with other inhaled corticosteroids and combination products.

Financial Trajectory

Revenue and Market Share

ASMANEX TWISTHALER, being a well-established product, contributes significantly to the revenue of its manufacturer. While specific financial figures for ASMANEX TWISTHALER are not publicly disclosed, the overall growth of the U.S. asthma drugs market indicates a favorable financial trajectory for such products.

Cost and Pricing

One of the major restraints in the U.S. asthma drugs market is the high cost of treatments. ASMANEX TWISTHALER, like other asthma medications, faces challenges related to affordability, especially for patients with inadequate insurance coverage or those from low-income communities. The cost is influenced by factors such as clinical trials, regulatory approvals, and research and development[3].

Clinical and Regulatory Aspects

Clinical Efficacy

ASMANEX TWISTHALER has demonstrated efficacy in clinical trials. For instance, studies have shown that it improves lung function and reduces symptoms in patients with asthma. The drug has been compared favorably to placebo in terms of mean trough FEV1 (Forced Expiratory Volume in one second) improvements[2].

Regulatory Approvals

The drug has received regulatory approvals, with its labeling and patient instructions carefully reviewed and updated by regulatory bodies. The FDA has ensured that the labeling accurately reflects the drug's efficacy and safety profile[2][4].

Safety and Side Effects

Common Adverse Reactions

ASMANEX TWISTHALER is associated with several common adverse reactions, including headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, and musculoskeletal pain[4].

Long-term Safety Concerns

Long-term use of ASMANEX TWISTHALER can lead to concerns such as reduction in bone mineral density, suppression of growth in children, and the development of glaucoma, increased intraocular pressure, and posterior subcapsular cataracts. These risks necessitate regular monitoring of patients[4].

Market Opportunities

Growing FDA Approvals

The increasing number of FDA approvals for new and repurposed drugs presents a lucrative opportunity for the asthma drugs market. ASMANEX TWISTHALER, as an established product, can benefit from this trend by potentially being used in combination with other approved medications or through new indications[3].

Strategic Initiatives

Pharmaceutical companies' strategic initiatives, such as product launches and collaborations, play a significant role in driving market growth. These initiatives can help expand the product portfolio and reach a wider patient population, potentially boosting the financial trajectory of ASMANEX TWISTHALER[3].

Financial Modeling and NPV Analysis

Net Present Value (NPV) Model

Evaluating the financial trajectory of ASMANEX TWISTHALER involves complex financial modeling, including NPV analysis. This requires a deep understanding of the drug's cash inflows and outflows, potential success rates at each stage of development, and market insights. GlobalData provides high-value NPV models that can help in this evaluation[1].

Key Takeaways

• Market Growth: The U.S. asthma drugs market is growing, driven by increasing prevalence, advancements in medical research, and rising healthcare expenditure.
• Competitive Landscape: ASMANEX TWISTHALER competes in a highly competitive market with other inhaled corticosteroids and combination products.
• Financial Trajectory: The product faces challenges related to high costs but benefits from growing market demand and strategic initiatives.
• Clinical Efficacy: ASMANEX TWISTHALER has demonstrated clinical efficacy and received regulatory approvals.
• Safety Concerns: Regular monitoring is necessary due to potential long-term safety concerns.

FAQs

1. What is ASMANEX TWISTHALER used for? ASMANEX TWISTHALER is used for the long-term control of asthma symptoms in patients 4 years of age and older[5].

2. What are the common side effects of ASMANEX TWISTHALER? Common side effects include headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, and musculoskeletal pain[4].

3. How does ASMANEX TWISTHALER compare to other asthma medications? ASMANEX TWISTHALER is an inhaled corticosteroid that competes with other similar products and combination therapies in the market. It has shown efficacy in clinical trials and is used for long-term control of asthma symptoms[2][5].

4. What are the long-term safety concerns associated with ASMANEX TWISTHALER? Long-term use can lead to reduction in bone mineral density, suppression of growth in children, and the development of glaucoma, increased intraocular pressure, and posterior subcapsular cataracts[4].

5. How does the high cost of ASMANEX TWISTHALER impact its market? The high cost of ASMANEX TWISTHALER can be a barrier for patients with inadequate insurance coverage or those from low-income communities, potentially limiting market growth despite its clinical efficacy[3].

Sources

1. GlobalData: Net Present Value Model: Asmanex Twisthaler - GlobalData
2. FDA: 205641Orig1s000 - accessdata.fda.gov
3. NovaOneAdvisor: U.S. Asthma Drugs Market Size, Share & Growth Report, 2033
4. FDA: Asmanex Twisthaler (mometasone furoate) inhalation powder label
5. Asthma & Allergy Foundation: Mometasone - Asmanex Twisthaler - Asthma & Allergy Foundation