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

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

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
Canada	1075228	UTILISATION DE LA FLUNISOLIDE DANS LE TRAITEMENT DES AFFECTIONS RESPIRATOIRES (FLUNISOLIDE TO TREAT RESPIRATORY DISEASES)

Last updated: July 16, 2026

NASALIDE patent, exclusivity, and investment fundamentals analysis (US launch risk, revenue exposure, and competitive threats)

NASALIDE has no citable public patent, FDA, Orange Book, exclusivity, or commercial dossier in the available dataset. Without drug identity certainty (active ingredient, dosage form, manufacturer, and reference listed drug), a complete and accurate investment scenario cannot be produced.

What is NASALIDE and which active ingredient is used?

No reliable, citable identification for NASALIDE (active ingredient, strength, dosage form, or sponsor) is available in the provided information environment.

What dosage forms and strengths does NASALIDE have

No citable product composition or formulation details are available.

What patents protect NASALIDE in the US and globally?

No citable NASALIDE patent estate is available.

How many patents cover NASALIDE and who owns them

No citable patent counts, assignees, or jurisdictional coverage are available.

Which formulations, methods-of-use, or manufacturing patents matter

No citable formulation, method-of-use, or manufacturing patents are available.

When does NASALIDE lose exclusivity in the US (Hatch-Waxman and FTC/FDC exclusivities)?

No citable exclusivity timelines are available.

Does NASALIDE have Orange Book listings

No citable Orange Book status is available.

What is the estimated first generic/biosimilar entry window

No citable exclusivity or reference product status is available.

What is the Orange Book status of NASALIDE?

No citable Orange Book listing is available for NASALIDE.

Which patents are listed for each dosage form

No citable Orange Book patent-by-patent mapping is available.

Do any patents expire soon (next 24 to 36 months)

No citable expiration schedule exists.

Which companies are challenging NASALIDE with Paragraph IV certifications?

No citable Paragraph IV actions or challengers are available.

What settlement agreements exist and what is the induced entry date

No citable settlements or agreed launch carve-outs are available.

How strong is the patent estate for NASALIDE?

No citable patent list exists to score enforceability, claim scope, remaining term, or typical litigation durability.

What claim types dominate (composition, formulation, use, device, manufacturing)

No citable claim-type inventory is available.

How many remaining years of protection are left

No citable expiration data is available.

What generic entry risks exist for NASALIDE (design-around and launch timing)?

No citable regulatory or patent posture is available to model generic design-around feasibility or launch timing.

What barriers block generic substitution

No citable formulation, polymorph, particle size, solubility, or device-control patents are available.

How does NASALIDE compare with competing intranasal or respiratory brands (patent and commercial pressure)?

No citable NASALIDE reference product profile or comparable competitors are available.

Which rival products face the same competitive clock

No citable competitor set exists.

What FDA regulatory status does NASALIDE have (NDA/ANDA/BLA pathway)?

No citable FDA approval pathway, application type, or regulatory milestones are available.

What is the FDA approval date and current label scope

No citable label or approval history is available.

Are there post-approval changes that affect patent risk (CBE supplements, new strengths)

No citable supplement history exists.

What formulation and manufacturing IP barriers exist for NASALIDE?

No citable formulation or manufacturing IP is available.

Are there device or delivery-system patents

No citable device or delivery-system IP is available.

What patent litigation affects NASALIDE (cases, jurisdictions, outcomes)?

No citable NASALIDE litigation docket is available.

Who sued whom and when

No citable case history exists.

What court rulings change the risk profile

No citable rulings exist.

Investment scenario: base case, downside case, and upside case

No citable NASALIDE fundamentals or time-to-entry drivers are available to construct an investment case tied to patent expiry, Paragraph IV timing, settlement outcomes, or FDA exclusivity.

Revenue exposure and market size

No citable NASALIDE sales, channel mix, market share, or pricing data is available.

Cost structure and supply-chain fragility

No citable manufacturing footprint or quality/compliance history is available.

Shareholder-risk events

No citable regulatory actions, safety signals, or manufacturing disruptions are available.

Key Takeaways

• NASALIDE cannot be investment-rated from patent, Orange Book, FDA, exclusivity, litigation, or commercial evidence because no citable NASALIDE dossier is available.
• No defensible timeline for generic entry, no patent strength score, and no litigation-based risk quantification can be produced.

FAQs

1. What active ingredient is NASALIDE and what reference listed drug is it tied to?
2. Where is NASALIDE listed in the FDA Orange Book by dosage form and patent number?
3. Have any generic applicants filed Paragraph IV certifications against NASALIDE?
4. What is the remaining patent term and estimated date for first generic market entry?
5. Has NASALIDE faced FDA enforcement actions, label changes, or safety communications that affect adoption and revenue?

References

No sources were cited.