NASALIDE Drug Patent Profile

Which patents cover Nasalide, and when can generic versions of Nasalide launch?

Nasalide is a drug marketed by Ivax Res and is included in one NDA.

The generic ingredient in NASALIDE 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 Nasalide

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

Summary for NASALIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	7,271
DailyMed Link:	NASALIDE at DailyMed

US Patents and Regulatory Information for NASALIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Res	NASALIDE	flunisolide	SPRAY, METERED;NASAL	018148-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for NASALIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ivax Res	NASALIDE	flunisolide	SPRAY, METERED;NASAL	018148-001	Approved Prior to Jan 1, 1982	4,933,168

International Patents for NASALIDE

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

Country	Patent Number	Title	Estimated Expiration
Austria	357702
Austria	A388376
Australia	1430176
Australia	506080
Belgium	842192

Last updated: July 28, 2026

NASALIDE (Nasal Spray) Market Dynamics and Financial Trajectory: Sales Trends, Competitive Pressure, and Exclusivity Risk

NasaliDE has limited public disclosure of revenues in standard financial databases under that brand name, and no clear, unambiguous mapping to a specific active ingredient and FDA-listed product is present in the available record used for this analysis. Without a validated NASALIDE-to-API-to-FDA product identity and issuer-level reporting, a precise market dynamics and financial trajectory assessment cannot be produced.

What is NASALIDE’s active ingredient and who manufactures it?

A market dynamics and financial trajectory assessment requires the drug’s active ingredient, dosage form, strength, and the FDA product mapping (listed drug name) to connect sales history, wholesaler demand, payer positioning, and exclusivity timelines to a concrete regulatory and patent record.

What matters for market sizing accuracy

• Brand-level wholesaler pull-through depends on whether NASALIDE is marketed as an FDA-approved prescription product, an OTC product, or a non-FDA-regulated cosmetic/OTC nasal product.
• Revenue reporting differs sharply by status:
  • Prescription NDC pull-through is captured in IQVIA/TractManager-style datasets (not reliably accessible without product mapping).
  • OTC nasal products can be tracked via different syndicated panels and wholesaler channels.
  • Non-system products may not show in mainstream drug revenue reporting.

How has NASALIDE’s sales trajectory changed over time?

Featured snippet answer: Not determinable from the provided identifier alone.

Key financial trajectory drivers to quantify (requires product mapping)

• Brand Rx/OTC growth versus category contraction (seasonality is common for nasal therapies).
• Channel mix changes: retail pharmacy vs mass retail vs direct-to-provider.
• Price actions: net price erosion, wholesaler discounting, and rebates.
• Competitive entries: generics, “authorized” equivalents, and line extensions.

What competitive threats affect NASALIDE’s market share?

A defensible competitive landscape requires knowing whether NASALIDE competes in one of these nasal categories:

• Intranasal corticosteroids
• Intranasal antihistamines
• Intranasal decongestants
• Saline/hypertonic solutions and device adjuncts
• Combination intranasal therapies

Competitive pressure signals that change financial trajectory

• NDC-level generic substitutions or therapeutic-class switching
• Formulary wins or losses driven by payer step edits
• Safety-driven utilization constraints (for decongestants, usage duration caps; for steroids, nasal irritation considerations)
• Delivery system competition (spray vs mist; plume deposition profile)

When does NASALIDE lose exclusivity and what patents block generics?

Featured snippet answer: Not determinable without a validated FDA listed drug and Orange Book patent linkage.

What typically determines exclusivity for nasal brands

• 5-year/3-year exclusivity tied to NDA/BLA approval status and patent certifications
• Patent expirations in the Orange Book for:
  • Drug substance
  • Drug product
  • Formulation and/or particle size/solubilization approach
  • Method of use (e.g., rhinitis subtypes)
  • Device or delivery method claims

What generic entry risks exist for NASALIDE (Paragraph IV, 505(b)(2), ANDA)?

Featured snippet answer: Not determinable without Orange Book certifications and litigation dockets tied to the correct listed drug.

Why the generic risk needs the exact NDC

• Paragraph IV challenges apply to specific Orange Book-listed patents for a specific listed drug.
• 505(b)(2) can introduce “same active, different formulation” products that still displace branded utilization without a full ANDA Paragraph IV strategy.
• Competitive risk also depends on whether the product is prescription-only or OTC, which changes labeling and approval pathways.

What is the Orange Book status of NASALIDE?

Featured snippet answer: Not determinable from the provided data.

Orange Book fields required for an executable answer

• Listed drug name and application number (NDA/BLA)
• Patent list with expiration dates and whether each is:
  • Composition of matter
  • Method-of-use
  • Drug product
• Patent-specific certification history (I, II, III, IV)

What patent litigation affects NASALIDE and how does it change settlement timing?

Featured snippet answer: Not determinable without case-level identifiers tied to NASALIDE’s correct active ingredient and FDA listed drug.

Litigation outcomes that materially shift financial trajectory

• Dismissals or covenant-not-to-sue that permit early generic launch
• Entry-blocking injunctions and final judgment dates
• Settlement agreements with:
  • “At-risk” launch carveouts
  • 180-day exclusivity assignments
  • Design-around timelines

How does NASALIDE compare with leading intranasal therapies on market dynamics?

Featured snippet answer: Not determinable without therapeutic classification and active ingredient mapping.

Comparable benchmarks that change conclusions

• Market leader dynamics (e.g., steroid sprays often dominate chronic allergic rhinitis)
• Subtype targeting (seasonal vs perennial)
• Payer preference patterns by formulary tier
• Switching thresholds: step therapy and prior authorization

What manufacturing and formulation IP barriers could limit follow-on competition?

Featured snippet answer: Not determinable without formulation identity and patent set.

Typical IP barrier categories for nasal sprays

• Suspension stability, particle size distribution, and rheology controls
• Preservative system and irritation profile
• Device components: actuator geometry, spray plume, pump efficiency
• Delivery performance: deposition in nasal cavity, droplet size

Where does NASALIDE fit in FDA regulatory status and labeling risk?

Featured snippet answer: Not determinable without the exact FDA application record.

Regulatory factors that influence sales

• Label expansion or restriction history
• Safety communications or boxed warnings (uncommon for most intranasal agents but depends on class)
• Post-marketing requirements that can slow replenishment or constrain promotion

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Key Takeaways

• A precise market dynamics and financial trajectory for NASALIDE cannot be produced from the provided brand identifier alone because NASALIDE is not mapped to a verifiable FDA product, active ingredient, and Orange Book/patent record in the analysis record used here.
• Any attempt to quantify sales trends, competitor impact, exclusivity loss, or generic entry timing would risk misidentification and material error.

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FAQs

1. How can NASALIDE’s sales be estimated if it is an OTC nasal product instead of prescription?
2. What data sources track intranasal nasal spray demand by NDC and how does that affect forecasting?
3. How do payer step edits typically impact intranasal corticosteroid versus antihistamine market share?
4. What is the usual timeline from FDA approval to generic displacement for nasal brands with multiple formulation patents?
5. How do device or actuator patents affect 505(b)(2) follow-on intranasal products even when the API matches?

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References

1. [No citable sources were used because NASALIDE’s FDA-listed identity, active ingredient, and Orange Book linkage were not provided in the input.]