ASMANEX HFA Drug Patent Profile

Which patents cover Asmanex Hfa, and what generic alternatives are available?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asmanex Hfa

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

Summary for ASMANEX HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	12
Patent Applications:	4,548
Drug Prices:	Drug price information for ASMANEX HFA
Drug Sales Revenues:	Drug sales revenues for ASMANEX HFA
What excipients (inactive ingredients) are in ASMANEX HFA?	ASMANEX HFA excipients list
DailyMed Link:	ASMANEX HFA at DailyMed

See drug prices for ASMANEX HFA

See drug sales revenues for ASMANEX HFA

Recent Clinical Trials for ASMANEX HFA

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Milton S. Hershey Medical Center	Phase 3
University of Dundee	Phase 4

See all ASMANEX HFA clinical trials

Pharmacology for ASMANEX HFA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ASMANEX HFA

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 HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-003	Aug 12, 2019		RX	Yes	No
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014		RX	Yes	No
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014		RX	Yes	Yes

Expired US Patents for ASMANEX HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014

International Patents for ASMANEX HFA

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

Country	Patent Number	Title	Estimated Expiration
China	1531967
Peru	44995	FUROATO DE MOMETASONA PARA EL TRATAMIENTO DE LAS ENFERMEDADES PULMONARES Y DE LAS VIAS RESPIRATORIAS
China	1139384
Austria	525075
China	101164542
Spain	2369516

Supplementary Protection Certificates for ASMANEX HFA

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
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
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
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	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

ASMANEX HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ASMANEX HFA

Introduction to ASMANEX HFA

ASMANEX HFA, an inhaled corticosteroid (ICS) containing mometasone furoate, is approved for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth

The U.S. asthma drugs market, within which ASMANEX HFA operates, is experiencing significant growth. As of 2023, the U.S. asthma drugs market was valued at USD 8.95 billion and is projected to surpass USD 14.75 billion by 2033, registering a Compound Annual Growth Rate (CAGR) of 5.12% over the forecast period[3].

Segmentation and Dominance

The U.S. asthma drugs market is categorized into pediatric, adult, and adolescent segments. The adult segment is the dominant force and is expected to maintain its market leadership throughout the forecast period. Given that ASMANEX HFA is indicated for patients 5 years and older, it benefits from this dominant segment, particularly in the adult population[3].

Competitive Landscape

The asthma drugs market is highly competitive, with various treatment options available. However, ASMANEX HFA has established itself as a significant player, especially with its approval for pediatric patients as young as 5 years old. This expanded indication has contributed to its market presence and growth potential[1][2].

Efficacy and Safety

Clinical trials, such as Trials P086 and P087, have demonstrated the efficacy of ASMANEX HFA in improving lung function and reducing asthma symptoms. For instance, Trial P086 showed a statistically significant change from baseline in percent predicted FEV1 at week 12 compared to placebo in children aged 5 to 11[1].

The safety profile of ASMANEX HFA has also been favorable, with no new safety concerns identified in postmarketing adverse event reports. The FDA's review of FAERS reports did not indicate any increased severity or frequency of labeled adverse events or deaths directly associated with ASMANEX HFA in pediatric patients[2].

Regulatory History and Approvals

ASMANEX HFA was initially approved in the U.S. on April 25, 2014. Subsequent approvals have expanded its indication to include treatment of patients aged 5 to 11, further broadening its market reach[2].

Patient Support and Access Programs

To facilitate access to ASMANEX HFA, various patient support programs offer reduced-cost or free medications to eligible individuals. Pharmaceutical companies and organizations such as the Partnership for Prescription Assistance and NeedyMeds provide valuable resources, which contribute to the medication's market growth by ensuring more patients can adhere to their prescribed treatment regimens[3].

Environmental and Regulatory Considerations

ASMANEX HFA, like other metered dose inhalers (MDIs), uses hydrofluoroalkane (HFA) propellants. The EPA monitors the environmental impact of these propellants, and while there are no immediate plans to replace HFC-134a and HFC-227ea with more environmentally friendly alternatives, the industry is expected to transition in the next 15 to 20 years. This could potentially impact the production and distribution costs of ASMANEX HFA, but current projections do not indicate a significant immediate impact on its market trajectory[4].

Financial Performance and Projections

Given the growing demand for asthma medications and the established efficacy and safety of ASMANEX HFA, the financial performance of this drug is expected to remain strong. The expansion of its indication to younger patients and the lack of new safety concerns have contributed to its stable market position.

Revenue Growth

The revenue from ASMANEX HFA is expected to grow in line with the overall asthma drugs market. With a CAGR of 5.12%, the market's expansion will likely drive increased sales of ASMANEX HFA, particularly as it remains a preferred treatment option for both pediatric and adult patients.

Market Share

ASMANEX HFA's market share within the asthma drugs segment is significant, particularly in the inhaled corticosteroid category. Its approval for a broader age range and its favorable safety and efficacy profile help maintain its market share against competitors.

Key Takeaways

• Market Growth: The U.S. asthma drugs market is projected to grow significantly, with ASMANEX HFA benefiting from this trend.
• Segment Dominance: The adult segment dominates the market, and ASMANEX HFA is well-positioned within this segment.
• Efficacy and Safety: Clinical trials have demonstrated the efficacy and safety of ASMANEX HFA, supporting its market presence.
• Regulatory Approvals: Expanded indications and favorable regulatory reviews have enhanced its market reach.
• Patient Support: Access programs contribute to better adherence and market growth.

FAQs

What is ASMANEX HFA used for?

ASMANEX HFA is used for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.

What are the key clinical trials that support the efficacy of ASMANEX HFA?

Trials P086 and P087 are significant clinical trials that demonstrated the efficacy of ASMANEX HFA in improving lung function and reducing asthma symptoms.

Are there any safety concerns associated with ASMANEX HFA in pediatric patients?

No new safety concerns have been identified in postmarketing adverse event reports for ASMANEX HFA in pediatric patients.

How does ASMANEX HFA fit into the broader asthma drugs market?

ASMANEX HFA is a significant player in the inhaled corticosteroid segment of the asthma drugs market, particularly benefiting from the dominant adult segment.

What environmental considerations might impact ASMANEX HFA production?

The use of HFC propellants in ASMANEX HFA may be subject to future environmental regulations, but current projections do not indicate an immediate significant impact.

Cited Sources:

1. FDA: NDA Multi-Disciplinary Review and Evaluation - FDA[1]
2. FDA: ASMANEX HFA NDA 205641 PAC REVIEW 2023 - FDA[2]
3. Biospace: U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033[3]
4. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry[4]