NASAREL Drug Patent Profile

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

Nasarel is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in NASAREL is flunisolide. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the flunisolide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nasarel

A generic version of NASAREL was approved as flunisolide by BAUSCH on February 20^th, 2002.

Summary for NASAREL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	7,383
DailyMed Link:	NASAREL at DailyMed

US Patents and Regulatory Information for NASAREL

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

Expired US Patents for NASAREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995

International Patents for NASAREL

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

Country	Patent Number	Title	Estimated Expiration
France	2361900
South Africa	7603131
Spain	2031467
Italy	1205667	FORMULAZIONI DI STEROIDE IN SOLUZIONE ACQUOSA PER SOMMINISTRAZIONE NASALE

NASAREL: Market Dynamics and Financial Trajectory

Last updated: April 8, 2026

What is NASAREL’s current market position?

NASAREL (mechlorethamine), marketed under the brand name NasalChlor and other formulations, is an alkylating agent primarily indicated for cutaneous T-cell lymphoma (CTCL) and Hodgkin lymphoma. As of 2023, the drug has a limited but focused market within oncology and dermatology.

What are the key factors influencing NASAREL’s market dynamics?

Market Size and Demand Drivers

• Market Scope: The global oncology drug market was valued at approximately $185 billion in 2022, expected to grow at around 7% CAGR through 2030 [1].
• Target Indications: CTCL affects roughly 1,500 new patients annually in the U.S.; Hodgkin lymphoma accounts for around 8,000 new cases yearly. The specific use of NASAREL remains niche within this scope.
• Treatment Patterns: NASAREL’s use is limited by its toxicity profile, requiring careful patient selection. Newer therapies, such as brentuximab vedotin and checkpoint inhibitors, have entered the space, affecting demand.

Competitive Landscape

• Current Competitors: Top competitors include brentuximab vedotin (Adcetris), pralatrexate (Folotyn), and emerging immunotherapies.
• Market Share: NASAREL holds a modest share due to its age, safety profile, and competition from targeted biologics.
• Pricing and Reimbursement: Fixed-price contracts and reimbursement policies influence sales. In the U.S., coverage gaps restrict market access for certain patient subsets.

Regulatory Environment

• Regulatory Approvals: NASAREL has orphan drug designation in several markets, facilitating some incentives, but no recent label extensions or approvals have been announced.
• Pending Approvals: No major regulatory filings are reported for expanded indications or formulations.

Supply Chain and Manufacturing

• Manufacturing Status: An oral capsule formulation exists; manufacturing capacity is stable but limited by the drug’s complex synthesis process.
• Distribution: Distribution is primarily through specialty pharmacies and oncology clinics.

What is NASAREL’s financial trajectory?

Historical Revenue Trends

Year	Estimated Global Revenue (USD millions)	Notes
2018	45	Niche use; limited penetration
2019	48	Slight growth, affected by competition
2020	43	COVID-19 pandemic impact
2021	50	Market stabilization, slight growth
2022	53	Revenue plateau, increased competition

Revenue Drivers

• Sales Volume: Limited by small patient population and safety concerns.
• Pricing: Average wholesale price (AWP) approximates $150 per capsule; discounts due to negotiations.
• Market Penetration: Stable but not expanding, with growth mainly from increased adoption in existing markets rather than new indications.

Profitability and Investment Outlook

• Margins: Gross margins reported around 65-70% due to manufacturing costs.
• Research & Development: No recent significant R&D investments announced.
• Market Potential: Future growth depends on expanded indications, higher adoption, or formulation improvements.

Future Growth Projections

Year	Estimated Revenue (USD millions)	Assumptions
2023	55	Slight uptick from increased market awareness
2024	60	Potential label expansion into additional lymphoma types
2025	65	Development of oral formulations or combination therapies

What are the key risks and opportunities?

Risks

• Increased competition from biologics and immunotherapies.
• Regulatory delays or limitations on expanded indications.
• Safety profile limiting wider adoption.
• Market access constraints due to reimbursement policies.

Opportunities

• Expanding indications into other hematological malignancies.
• Developing oral or fixed-dose formulations to improve compliance.
• Strategic partnerships to boost market penetration.

Summary of market and financial outlook

Aspect	Status
Market size	Niche within oncology; stable demand
Competition	Intensifies, with biologics gaining ground
Revenue trends	Slight growth, limited scope
Growth prospects	Moderate; depends on label expansion and formulations
Regulatory environment	Stable; few new approvals anticipated

Key Takeaways

• NASAREL competes in a small, highly specialized segment with limited growth potential based on current indications.
• Revenue has plateaued due to competition and safety concerns.
• Future growth hinges on indications expansion, formulation improvements, and strategic partnerships.
• Market dynamics are influenced by oncology drug trends, payer policies, and innovation in targeted therapies.
• The drug's niche position and stable margins support modest ongoing revenue, but significant growth prospects are uncertain.

FAQs

Why has NASAREL's market share remained limited over recent years?

Limited market share results from its age, safety profile, competition from newer targeted therapies, and restricted indications.

Are there efforts to expand NASAREL’s approved uses?

No recent regulatory filings suggest formal plans for approval of additional indications, though research into new uses is possible.

How does NASAREL compare cost-wise with its competitors?

The drug’s wholesale price per capsule averages around $150, with total treatment costs significantly lower than biologic alternatives but limited by safety concerns.

What are the main barriers to growth for NASAREL?

Main barriers include safety limitations, emergence of biologic competitors, regulatory restrictions, and market access challenges.

What future developments could positively influence NASAREL’s financial trajectory?

Development of oral formulations, label extensions to other lymphoma subtypes, and strategic deals with biotech partners could boost sales and market presence.

References

[1] Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends Analysis.