Flunisolide - Generic Drug Details

What are the generic sources for flunisolide and what is the scope of patent protection?

Flunisolide is the generic ingredient in five branded drugs marketed by Roche Palo, Pharmobedient, Apotex, Bausch, Riconpharma Llc, Rising, Ivax Res, and Teva Branded Pharm, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for flunisolide. Three suppliers are listed for this compound.

Summary for flunisolide

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	8
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	4
Drug Prices:	Drug price trends for flunisolide
Drug Sales Revenues:	Drug sales revenues for flunisolide
What excipients (inactive ingredients) are in flunisolide?	flunisolide excipients list
DailyMed Link:	flunisolide at DailyMed

See drug prices for flunisolide

See drug sales revenues for flunisolide

Recent Clinical Trials for flunisolide

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

Sponsor	Phase
University of Louisville	N/A
Meda Pharmaceuticals	N/A
GlaxoSmithKline	Phase 3

See all flunisolide clinical trials

Pharmacology for flunisolide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for flunisolide

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for flunisolide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995		DISCN	No	No
Roche Palo	AEROBID	flunisolide	AEROSOL, METERED;INHALATION	018340-001	Aug 17, 1984		DISCN	No	No
Bausch	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	074805-001	Feb 20, 2002	AB	RX	No	Yes
Rising	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	077704-001	Aug 3, 2006	AB	RX	No	No

Expired US Patents for flunisolide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	AEROBID	flunisolide	AEROSOL, METERED;INHALATION	018340-001	Aug 17, 1984
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995
Pharmobedient	AEROSPAN HFA	flunisolide	AEROSOL, METERED;INHALATION	021247-001	Jan 27, 2006
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995

Market Dynamics and Financial Trajectory for Flunisolide

Last updated: February 20, 2026

What is Flunisolide and How Is It Used?

Flunisolide is a synthetic corticosteroid used primarily as a nasal spray and inhaler for allergic rhinitis and asthma. Its anti-inflammatory properties reduce swelling and mucus production in nasal passages and airways. Approved for medical use since the 1970s, it is marketed under various brand names, including Aerospan, Nasarel, and Nasalide.

Current Market Position

Market data indicates that Flunisolide holds a modest share within the respiratory and allergy therapeutics segment. The global corticosteroid nasal spray market was valued at approximately USD 1.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.2% through 2030 [1]. Flunisolide's market share is estimated between 5-10% of this segment, owing to competition from newer, more advanced agents.

In the inhaled corticosteroid (ICS) category for asthma, Flunisolide's presence is limited. Recent guidelines favor newer agents with improved delivery mechanisms. As a result, it accounts for less than 2% of the USD 15 billion global ICS market, which is growing at a CAGR of approximately 4% [2].

Market Drivers and Barriers

Drivers

• Established efficacy and safety profile: Decades of clinical data support Flunisolide's use, reinforcing clinician confidence.
• Generic availability: The loss of patent exclusivity has increased affordability and access in many markets.
• Prevalence of allergic rhinitis and asthma: Rising global incidence sustains demand.
• Regulatory approvals in emerging markets: Expanding access in countries with increasing healthcare infrastructure.

Barriers

• Competition from newer agents: Beclomethasone, mometasone, and fluticasone furoate offer better delivery or fewer side effects.
• Limited formulation innovation: Lack of new delivery systems reduces appeal.
• Market saturation: Mature markets display slow growth and high generic penetration, suppressing margins.

Regulatory Landscape

• Widely approved across North America, Europe, and Asia.
• Regulatory barriers are minimal in developed markets but may exist in regulatory environments with stringent pharmacovigilance requirements.
• Patent expirations occurred in the 2000s and 2010s, increasing generic competition [3].

Financial Trajectory Predictions

Analysis of historical sales data and market share trends suggests a stagnant or declining revenue pattern for Flunisolide-based products, especially in mature markets.

Year	Estimated Revenue (USD millions)	Growth Rate	Notes
2020	150	-2%	Decline attributed to heightened competition
2021	140	-6.7%	Continued erosion of market share
2022	130	-7.1%	Marginal recovery in emerging markets due to expansion
2023	125	-3.8%	Flat growth expected as generic saturation persists

Forecasts indicate minimal growth through 2025, with revenues stabilizing around USD 120-130 million annually unless new formulations or delivery mechanisms emerge.

Investment and R&D Outlook

Limited R&D investment remains attributed to reduced profit margins and market saturation. Patent expirations have diminished incentives for originators, augmenting reliance on generic manufacturers. Some companies explore combination therapies with other asthma or allergy medications, which could provide new revenue streams, but these are in early development phases [4].

Potential Opportunities

• Development of combination inhalers or nasal sprays with improved compliance or reduced dosing frequency.
• Expansion into untapped regional markets with rising allergy prevalence.
• Formalization of off-label uses to extend patent exclusivity or create new markets.

Risks and Uncertainties

• Emergence of new biologic therapies targeting allergic rhinitis and asthma.
• Regulatory shifts increasing scrutiny of corticosteroid safety profiles.
• Pricing pressures due to increased generic competition.

Key Takeaways

• Flunisolide remains a recognized, low-cost corticosteroid used in allergy and asthma management.
• Market share is declining, especially in mature markets, due to competition from newer agents and formulations.
• Revenue is forecasted to stay stable or decline slightly unless innovation occurs.
• Opportunities hinge on formulation innovation and geographic market expansion.
• Industry consolidation and patent expirations will continue to pressure profitability.

FAQs

1. Will Flunisolide regain market share in the future?

Unlikely without new formulations or delivery technologies. The trend favors newer agents with better tolerability and convenience.

2. Are there ongoing R&D efforts for Flunisolide?

Limited. Most R&D focus has shifted to biologics and combination therapies with enhanced efficacy and targeted delivery.

3. How does Flunisolide compare with other corticosteroids?

It has a comparable efficacy profile but less advanced delivery options compared to newer agents like fluticasone or mometasone.

4. What are the major markets for Flunisolide?

North America and Europe account for most sales but are highly saturated. Growth opportunities exist mainly in Asia-Pacific and Latin America.

5. Could the patent expirations lead to a price collapse?

Patent expirations increased generic competition, which lowers prices. Without innovation, revenue reductions are expected.

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References

[1] Grand View Research. (2023). Corticosteroid nasal sprays market size and forecast.
[2] Global Data. (2022). Inhaled corticosteroids market analysis.
[3] U.S. FDA. (2019). Drug patent expirations.
[4] ClinicalTrials.gov. (2022). Emerging combination therapies for asthma and allergy.