Drugs in MeSH Category Nasal Decongestants

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	207926-002	Jan 15, 2015	AT	RX	Yes	No
Kenvue Brands	VISINE L.R.	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019407-001	Mar 31, 1989		OTC	Yes	Yes
Rising	NAPHAZOLINE HYDROCHLORIDE	naphazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	083590-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sandoz	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	208905-001	Jan 31, 2019	AP1	RX	No	No
Somerset Theraps Llc	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	215617-001	Feb 14, 2025	AP	RX	No	No

Nasal Decongestants Market Analysis and Financial Projection

The global nasal decongestant market is experiencing robust growth, driven by rising respiratory ailments and innovations in drug delivery. This analysis integrates market trends, regional dynamics, and patent developments shaping the industry.

Market Growth and Segmentation

• The decongestant market is projected to grow from $15.73 billion in 2023 to $24.67 billion by 2030, at a 6.6% CAGR [1][6]. Nasal sprays, the fastest-growing segment, benefit from rapid action and ease of use [15].
• Oxymetazoline, a key active ingredient, dominates the nasal spray market, with sales projected to reach $3.7 billion by 2030 (27% CAGR) [16].
• Market segmentation includes:
  • Product types: Tablets, capsules, nasal sprays (leading growth due to delivery efficiency).
  • Applications: Hospitals (largest share) and clinics (fastest-growing due to prescription volume) [15].

Regional Dynamics

• North America leads with high healthcare spending and allergy prevalence [1][6], while Asia-Pacific emerges as the fastest-growing region due to expanding healthcare access in India and China [1].
• Europe sees innovation in preservative-free formulations, with Germany and France driving CAGR rates of 4.3% and 7.0%, respectively [14].

Patent Landscape and Innovations

Key Expiring Patents (2025)

1. Ryaltris (Glenmark): A corticosteroid-antihistamine nasal spray for allergies, forecasted to lose exclusivity in January 2025 [4].
2. Sancuso (Cumberland): A transdermal anti-nausea patch expiring in January 2025 [4].
3. Tudorza/Duaklir Pressair (Covis Pharma): COPD treatments facing patent expiration in February 2025 [4].

Emerging Patent Filings

• COVID-19 Nasal Sprays: Halberd Corporation’s provisional patent combines antibodies targeting ACE2 and Neuropilin-1 receptors to block viral entry [2].
• Combination Therapies:
  • Antihistamine-Decongestant formulations with modified-release mechanisms (e.g., fexofenadine + pseudoephedrine) [10].
  • Moisturizing Additives: Patents like US20200246311 integrate dexpanthenol and hyaluronic acid to counteract nasal dryness from decongestants [7].
• Non-Respiratory Applications: Altamira’s Bentrio® (patented in 2025) addresses allergic rhinitis and ocular symptoms [13], while Evoke Pharma’s GIMOTI explores nasal delivery for gastroparesis [9].

Challenges and Trends

• Rebound Congestion: Prolonged use of oxymetazoline or xylometazoline sprays risks rhinitis medicamentosa [12].
• Regulatory Scrutiny: Phenylephrine’s efficacy debates and pseudoephedrine’s cardiovascular side effects drive reformulation efforts [15].
• Smart Devices: AI-enabled nasal sprays and telemedicine integration aim to personalize dosing and reduce misuse [16].

Future Outlook

• Non-Respiratory Expansion: 50% of nasal clinical trials target CNS disorders, anti-infectives, and vaccines [5].
• CDMO Partnerships: Catalent and Proveris Laboratories enhance capabilities for inhaled/nasal drug development, catering to small biotechs [5].

“Nasal sprays are evolving beyond allergies to address systemic conditions, driven by patient-centric innovation.” – Future Market Insights Analyst [14].

In summary, the nasal decongestant sector is poised for transformative growth, blending therapeutic expansion with advanced delivery systems, while navigating regulatory and efficacy challenges.

References

1. https://www.coherentmarketinsights.com/market-insight/decongestant-market-5805
2. https://drug-dev.com/halberd-corporation-files-for-patent-protection-on-enhanced-nasal-spray-to-prevent-covid-19/
3. https://meshb.nlm.nih.gov/record/ui?ui=D014663
4. https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
5. https://drug-dev.com/wp-content/uploads/2021/06/Repiratory-ebook-2021.pdf
6. https://www.coherentmarketinsights.com/market-insight/decongestant-market-5805/market-size-and-trends
7. https://patents.justia.com/patent/20200246311
8. https://medlineplus.gov/druginfo/meds/a608026.html
9. https://www.biospace.com/press-releases/evoke-pharma-receives-notices-of-allowance-for-two-additional-us-patent-applications-protecting-gimoti
10. https://patents.google.com/patent/US20080085311A1/en
11. https://patents.google.com/patent/US11833245B2/en
12. https://patient.info/treatment-medication/decongestants
13. https://www.biospace.com/press-releases/altamira-announces-notice-of-allowance-from-uspto-for-bentrio-nasal-spray-patent
14. https://www.globenewswire.com/news-release/2025/03/03/3035394/0/en/Global-Nasal-Sprays-Market-Poised-for-Significant-Growth-Expected-to-Reach-USD-28-345-5-Million-by-2035-grow-at-a-CAGR-of-6-0-Future-Market-Insights-Inc.html
15. https://www.drugpatentwatch.com/p/drug-price/drugname/SUDOGEST
16. https://www.verifiedmarketreports.com/product/global-oxymetazoline-market-growth-status-and-outlook-2019-2024/