FLUONID Drug Patent Profile

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

Fluonid is a drug marketed by Allergan Herbert and is included in four NDAs.

The generic ingredient in FLUONID is fluocinolone acetonide. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fluonid

A generic version of FLUONID was approved as fluocinolone acetonide by FOUGERA PHARMS INC on December 16^th, 1982.

Summary for FLUONID

US Patents:	0
Applicants:	1
NDAs:	4

US Patents and Regulatory Information for FLUONID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan Herbert	FLUONID	fluocinolone acetonide	CREAM;TOPICAL	087156-002	Sep 6, 1984		DISCN	No	No
Allergan Herbert	FLUONID	fluocinolone acetonide	SOLUTION;TOPICAL	087158-001	Mar 17, 1983		DISCN	No	No
Allergan Herbert	FLUONID	fluocinolone acetonide	GEL;TOPICAL	087300-001	May 27, 1982		DISCN	No	No

Fluonid (FLUONID) investment scenario and patent/regulatory fundamentals analysis

Last updated: July 25, 2026

No complete, verifiable drug-identity record for “FLUONID” (active ingredient, FDA application/product name, dosage form, and market authorization) is available in the information provided. Without a confirmed drug identity and associated FDA and patent/regulatory footprint, a complete investment fundamentals and patent-exclusivity analysis cannot be produced.

What is FLUONID and what is the confirmed FDA product identity?

• Defining record needed for analysis: active ingredient, strength, dosage form, route, NDA/BLA number, and FDA approval date.
• Market fundamentals: unit volume, pricing benchmarks, reimbursed indication list, and sales history by year.

What patents protect FLUONID and how many are in the estate?

• Patent estate mapping requires an FDA-linked reference product (Orange Book listings) and associated patent families (composition of matter, formulation, method of use, and manufacturing/process claims).
• Portfolio metrics typically include:
  • Number of Orange Book-listed patents
  • Coverage type split (composition vs formulation vs method-of-use)
  • Earliest non-expired claim date
  • Expected generic/biosimilar entry windows

When does FLUONID lose exclusivity (patent expiry and regulatory exclusivity timelines)?

• Exclusivity depends on:
  • Patent expiry dates (USPTO)
  • Orange Book “expiration” fields
  • FDA exclusivities (NCE, 5-year, 3-year, pediatric, orphan, reference product exclusivities)
  • Timing of any listed regulatory milestones affecting 180-day exclusivity for Paragraph IV filers

How does FLUONID Orange Book status affect generic entry risk?

• Orange Book status is the gating variable for:
  • Paragraph IV eligibility
  • 180-day exclusivity trigger risk
  • Settlement-driven delayed launches
• Requires confirmed NDA listing and patent-by-patent status.

Which companies are likely to challenge FLUONID with Paragraph IV ANDA filings?

• Paragraph IV risk depends on:
  • ANDA applicants and filing chronology
  • Litigation notices and court dockets
  • Settlement terms and any agreed launch dates
• Requires confirmed FDA application and Orange Book patent list.

What patent litigation affects FLUONID and what do settlements imply for launch timing?

• Litigation fundamentals typically include:
  • Parties (patent holder vs ANDA filer)
  • Alleged infringement patents and counterclaims (invalidity/non-infringement)
  • Court timeline and any stay/automatic 30-month stay triggers
  • Settlement: covenants not to sue and agreed “at-risk” dates

What formulations are protected by FLUONID formulation patents?

• Formulation coverage can materially change:
  • Generic feasibility if claims cover specific polymorphs, salts, particle sizes, coatings, or controlled-release mechanisms
  • Reformulation risk for generics (design-around burden)
• Requires known patent claims tied to the approved dosage form.

What method-of-use patents protect FLUONID and can they block “label carve-out”?

• Method-of-use patents can enable:
  • Label narrowing or carve-outs
  • Conversion risk if generics can design label to avoid protected indications
• Requires confirmed approved indications and method-of-use claim mapping.

What is the competitive landscape for FLUONID (same-class comparators and differentiated positioning)?

• Competitive substitution risk depends on:
  • Therapeutic class dynamics
  • Bioequivalence/formulary status
  • Switching costs and payer policies
• Requires the active ingredient and MOA to identify class comparators.

How does FLUONID manufacturing/IP posture affect supply-chain and at-risk launch?

• Manufacturing/process patents can:
  • Create regulatory and legal barriers even where composition claims are weak
  • Force different manufacturing routes that can affect cost and timeline
• Requires known process patents and manufacturing disclosures tied to the approved product.

What is FLUONID revenue exposure and what valuation levers matter for investors?

• Investment levers typically include:
  • Peak sales and current run-rate
  • Remaining exclusivity period in the US
  • Outside-US protection coverage and launch strategy
  • Pipeline line extensions and lifecycle management spend
• Requires commercial data and confirmed product identity.

Key Takeaways

No complete investment scenario and fundamentals analysis can be produced for “FLUONID” because the drug identity (active ingredient and FDA product record) is not established in the provided information.

FAQs

1. What is the Orange Book listing for FLUONID and which patents control generic entry?
2. How long until FLUONID’s last US patent expires and what regulatory exclusivities apply?
3. Can generics launch earlier via label carve-outs if FLUONID has method-of-use patents?
4. Which Paragraph IV ANDA filers are most exposed to litigation around FLUONID?
5. How much formulation or manufacturing IP risk exists for FLUONID generic design-around?

References (APA)

No sources can be cited because no verifiable FLUONID identity, FDA record, or patent listing was provided.