NASONEX Drug Patent Profile

Which patents cover Nasonex, and what generic alternatives are available?

Nasonex is a drug marketed by Organon Llc and Perrigo Pharma Intl and is included in two NDAs.

The generic ingredient in NASONEX 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 Nasonex

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

Summary for NASONEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	60
Patent Applications:	4,474
Drug Prices:	Drug price information for NASONEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASONEX
What excipients (inactive ingredients) are in NASONEX?	NASONEX excipients list
DailyMed Link:	NASONEX at DailyMed

See drug prices for NASONEX

See drug sales revenues for NASONEX

Recent Clinical Trials for NASONEX

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

Sponsor	Phase
Yingu Pharmaceutical Co., Ltd	Phase 4
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
EMS	Phase 3

See all NASONEX clinical trials

Paragraph IV (Patent) Challenges for NASONEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASONEX	Nasal Spray	mometasone furoate	50 mcg/ Spray	020762	1	2009-08-07

US Patents and Regulatory Information for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997		DISCN	Yes	No
Perrigo Pharma Intl	NASONEX 24HR ALLERGY	mometasone furoate	SPRAY, METERED;NASAL	215712-001	Mar 17, 2022		OTC	Yes	Yes

Expired US Patents for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	4,472,393*PED
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	6,723,713*PED
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	6,127,353*PED
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	5,837,699*PED

International Patents for NASONEX

See the table below for patents covering NASONEX around the world.

Country	Patent Number	Title	Estimated Expiration
China	1030920
South Africa	9107148
Finland	820280
Hong Kong	185996	Mometasone furoate monohydrate process for making same and pharmaceutical compositions
Norway	20025002

Supplementary Protection Certificates for NASONEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0057401	SPC/GB93/085	United Kingdom		SPC/GB93/085, EXPIRES: 20050621
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

NASONEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nasonex (Mometasone Furoate)

Introduction

Nasonex, a brand name for the steroid mometasone furoate, is a widely used medication for treating nasal congestion, runny nose, sneezing, and itchy nose associated with hay fever or other upper respiratory allergies. Here, we delve into the market dynamics and financial trajectory of this drug.

Global Market Size and Growth

The global mometasone furoate market, which includes Nasonex, is projected to exhibit significant growth. As of 2022, the market was valued at approximately $1,182.9 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.4% from 2022 to 2030, reaching a projected value of $2,099.8 million by 2030[4].

Market Drivers

Several factors are driving the growth of the mometasone furoate market:

Increasing Prevalence of Asthma and Allergies

The rising global prevalence of asthma and allergies is a major driver. According to the World Health Organization (WHO), in 2019, an estimated 262 million people were affected by asthma worldwide, and 455,000 individuals died from asthma. This increasing prevalence is expected to fuel the demand for mometasone furoate products like Nasonex[1].

Product Launches and Approvals

Recent product launches and approvals are also boosting market growth. For example, in March 2022, the U.S. Food and Drug Administration (FDA) approved Perrigo Company plc's Nasonex 24HR Allergy (mometasone furoate) nasal spray, which treats symptoms of hay fever and other upper respiratory allergies[4].

COVID-19 Impact

Interestingly, the COVID-19 pandemic has had a positive impact on the market. A study published in the journal International Immunopharmacology found that intranasal mometasone furoate spray improved olfactory and taste dysfunctions in COVID-19 patients, further increasing its demand[4].

Distribution Channels and Route of Administration

The global mometasone furoate market is segmented by dosage form, indication, route of administration, and distribution channel. Nasonex is predominantly available as a nasal spray, which is a preferred route of administration for treating nasal allergies. The distribution channels include pharmacies, hospitals, and online retailers, with pharmacies being the primary distribution channel[1][4].

Competitive Landscape

The market for mometasone furoate is competitive, with several key players involved:

• Organon & Co.: Although Organon & Co. is more known for its women's health and biosimilars franchises, it is part of the broader pharmaceutical landscape that includes mometasone furoate products[2][5].
• Perrigo Company plc: Known for its private label over-the-counter pharmaceuticals, Perrigo's FDA approval for Nasonex 24HR Allergy has been a significant development[4].
• Other Players: Companies like Cipla, Teva Pharmaceuticals, Glenmark Pharmaceuticals, and Hikma Pharmaceuticals also play crucial roles in the market[4].

Financial Performance

The financial performance of companies involved in the mometasone furoate market reflects the overall growth trends:

Revenue Growth

Organon & Co., for instance, has shown solid financial performance, with revenue growth across various segments. While their primary focus is on women's health and biosimilars, the broader pharmaceutical market dynamics influence their overall financial health. In 2023, Organon & Co. reported a revenue of $6.3 billion, with a 3% revenue growth at constant currency[5].

Profitability

The profitability of these companies is also noteworthy. Organon & Co. reported an adjusted EBITDA margin of 31% in 2023, indicating strong profitability. The company's financial guidance for 2024 includes a revenue range of $6.2 billion to $6.5 billion, representing about 3% growth on a constant currency basis[5].

Regional Outlook

The global mometasone furoate market is segmented by region, with significant growth expected across various geographies. The market dynamics vary by region, influenced by factors such as healthcare infrastructure, regulatory environments, and prevalence of allergies and asthma[1][4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry. While it posed challenges such as reduced access to healthcare providers and increased costs for research and development, it also created new opportunities. For mometasone furoate, the pandemic highlighted its potential in treating COVID-19-related olfactory and taste dysfunctions, thereby boosting its demand[4].

Key Insights from Industry Experts

Industry experts emphasize the importance of continuous innovation and regulatory approvals in driving market growth.

"Despite extraordinary challenges brought on by the COVID-19 pandemic, [companies] achieved solid growth and made meaningful progress in our pipeline... Our scientists continue to advance our internal pipeline of promising medicines and vaccines," said Kenneth C. Frazier, former chairman and CEO of Merck[3].

Illustrative Statistics

• Market Value: The global mometasone furoate market was valued at $1,182.9 million in 2022 and is expected to reach $2,099.8 million by 2030[4].
• CAGR: The market is expected to grow at a CAGR of 7.4% from 2022 to 2030[4].
• Asthma Prevalence: An estimated 262 million people were affected by asthma worldwide in 2019[1].

Conclusion

The market dynamics for Nasonex (mometasone furoate) are driven by increasing prevalence of allergies and asthma, recent product launches and approvals, and the positive impact of the COVID-19 pandemic. The financial trajectory of companies involved in this market reflects solid revenue growth and profitability, with a strong outlook for the future.

Key Takeaways

• The global mometasone furoate market is expected to grow at a CAGR of 7.4% from 2022 to 2030.
• Increasing prevalence of asthma and allergies is a major market driver.
• Recent product launches and approvals, such as Perrigo's Nasonex 24HR Allergy, are boosting market growth.
• The COVID-19 pandemic has positively impacted the market by highlighting new uses for mometasone furoate.
• Companies like Organon & Co. and Perrigo Company plc are key players in the market.

FAQs

Q: What is the current market size of the global mometasone furoate market? A: The global mometasone furoate market was valued at approximately $1,182.9 million in 2022[4].

Q: What is the expected CAGR of the global mometasone furoate market from 2022 to 2030? A: The market is expected to grow at a CAGR of 7.4% from 2022 to 2030[4].

Q: How has the COVID-19 pandemic impacted the mometasone furoate market? A: The pandemic has positively impacted the market by highlighting new uses for mometasone furoate, such as treating COVID-19-related olfactory and taste dysfunctions[4].

Q: Which companies are key players in the mometasone furoate market? A: Key players include Organon & Co., Perrigo Company plc, Cipla, Teva Pharmaceuticals, and Glenmark Pharmaceuticals[4].

Q: What is the primary route of administration for Nasonex? A: The primary route of administration for Nasonex is as a nasal spray[1][4].

Sources

1. Business Wire: Mometasone Furoate Global Market Report 2022 - ResearchAndMarkets.com
2. Stock Titan: Organon Reports Results for the Third Quarter Ended September 30
3. Merck: Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results
4. Coherent Market Insights: Mometasone Furoate Market Size, Trends and Forecast to 2030
5. Investing.com: Earnings call: Organon exceeds guidance with solid Q4 and full-year results