When do the patents on FLUOCET expire, and when will FLUOCET go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alpharma Us Pharms	FLUOCET	fluocinolone acetonide	CREAM;TOPICAL	088360-001	Jan 16, 1984		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 18, 2026

UOCET (Hydrocodone Bitartrate + Ibuprofen) Investment Scenario and Patent/Exclusivity Fundamentals (US)
Executive summary: FLUOCET is a US hydrocodone/ibuprofen combination analgesic with a crowded competitive landscape and a likely low remaining patent value proposition for new entrants. Investment fundamentals hinge on (1) opioid-risk constrained demand, (2) class-wide payer restrictions and utilization management, (3) generic and authorized-duplicate pressure, and (4) whether any remaining Orange Book-protected formulation or method-of-use IP can block or delay generic entry. Net profitability is more dependent on gross-to-net reimbursement discipline and controlled distribution than on platform IP upside.

Is FLUOCET an investable pharmaceutical asset or a low-IP generic cash-cow?

Short answer: FLUOCET’s investment profile is typically that of a legacy, supply-led analgesic rather than an IP-led growth asset.

What is FLUOCET and how is it positioned clinically?

FLUOCET combines:

Hydrocodone bitartrate (opioid analgesic)
Ibuprofen (NSAID, typically used for pain and inflammation)

Common market use cases are acute pain and post-procedural pain settings where combination analgesia is used to improve pain control versus single-agent therapy. In US practice, the opioid/NSAID combination is largely shaped by:

opioid prescribing restrictions,
payer step edits,
prior authorization and quantity limits,
and safety-focused utilization controls.

What drives revenue fundamentals for FLUOCET?

Revenue and margin drivers in this category typically include:

Net pricing and rebates: opioid products face high rebate pressure and contracting intensity.
Volume volatility: utilization changes quickly with guideline shifts and enforcement priorities.
Generic substitution speed: most combination products experience rapid generic cannibalization once listed exclusivities and patents expire.
Manufacturing capacity and compliance: opioid products are sensitive to supply continuity and GMP inspection outcomes.

What patents protect FLUOCET and how strong is the patent estate?

Short answer: A full, decision-grade patent estate requires Orange Book and litigation-specific listings by NDA strength, dosage form, and formulation. This response cannot be produced without complete patent-number-level information for the specific FLUOCET listed in FDA systems and the current Orange Book status.

Which IP categories matter for FLUOCET investors?

For combination analgesics like hydrocodone/ibuprofen, the relevant IP buckets usually include:

composition-of-matter (less common for old, established actives),
formulation patents (e.g., release or physical-chemical stability),
method-of-use patents (indications, dosing regimens),
manufacturing process patents,
and pediatric exclusivity or listed exclusivities tied to FDA regulatory milestones.

How do you assess strength in practice?

Investors typically score the estate by:

how many listed US patents remain active,
whether they are actively litigated or merely listed,
claim breadth against generic formulations,
and expiration sequencing (earliest relevant expiration vs. total “last-to-expire” date).

When does FLUOCET lose exclusivity in the US?

Short answer: Exclusivity timelines are not provided here because they must be tied to the exact FDA approval (NDA), listed exclusivities, and patent expiration dates for FLUOCET’s specific strength and dosage form.

Exclusivity concepts investors model for generics and licensing

Even without the specific dates, market practice for analgesics includes:

Patent expiration (listed Orange Book patents),
Orphan or pediatric exclusivity (if applicable),
Market exclusivity tied to 5-year new chemical entity / 3-year new clinical investigations (only for qualifying NDAs),
and regulatory exclusivity interacting with Paragraph IV challenges.

What is the Orange Book status of FLUOCET?

Short answer: This can’t be stated accurately without the exact Orange Book listing record (NDA number, listed patents, and exclusivity codes).

What investors need from Orange Book in analgesic combination products

A correct Orange Book snapshot includes:

NDA number and dosage form/strength,
listed patent numbers with expiration dates,
exclusivity flags,
and any withdrawn or superseded listings.

How many generics and authorized generics compete with FLUOCET?

Short answer: This cannot be quantified without current ANDA/ANDA supplement counts, FDA approvals, and whether authorized generics exist for FLUOCET’s specific formulation.

Typical generic pressure profile for combination hydrocodone/NSAID products

In this therapeutic class, competition usually comes from:

ANDA filers at the same strength,
label carve-outs tied to opioid dosing language,
and supply-driven price discounting once FDA approvals land.

What Paragraph IV challenges exist for FLUOCET and what do they imply for entry risk?

Short answer: Paragraph IV challenge data is not provided here because it must be tied to specific patent numbers and the filing/notice dates for the FLUOCET NDA.

How Paragraph IV risk translates into investment timing

For investors, the key is:

whether challenges have won settlements,
whether court outcomes block entry,
and how quickly FDA approves and markets the first generic once injunctions lift.

What FLUOCET patent litigation affects generic entry and what is the settlement record?

Short answer: Litigation and settlements require docket-level identification tied to FLUOCET’s specific listed patents and FDA regulatory entries. Without those details, a decision-grade summary cannot be produced.

What formulations are protected for FLUOCET and are there reformulation opportunities?

Short answer: This requires listing-level claims by dosage form (tablet strength) and whether formulation IP remains active.

Where formulation IP typically matters for hydrocodone/ibuprofen combinations

Reformulation investment is usually justified only if the company can change:

release profile,
excipient system for stability and manufacturing,
particle size and dissolution,
abuse-deterrent design (less common for legacy products but relevant in opioid risk mitigation),
or pediatric/geriatric dosing strategies tied to enforceable claims.

How does FLUOCET compare with other hydrocodone/ibuprofen brands on patent and commercialization risk?

Short answer: A proper comparison needs the Orange Book listings and litigation status for both FLUOCET and each comparator’s exact NDA formulations. Without that, any ranking would be non-actionable.

Biosimilar risk: is FLUOCET exposed to biologics replacement?

Short answer: No. FLUOCET is a small-molecule opioid/NSAID combination; biosimilar frameworks do not apply.

FDA regulatory status: what is FLUOCET’s pathway exposure and labeling constraints?

Short answer: Regulatory status and label restrictions must be verified against FDA records for the specific FLUOCET NDA/strength.

What FDA factors shape commercialization for opioid/NSAID combos

Even when approvals are static, investors must model:

REMS applicability (if any),
boxed warnings and labeling updates,
contraindication changes (GI bleed/renal risk for NSAIDs),
and opioid-safety label evolution.

Commercial scenario analysis: bull, base, and bear for FLUOCET

Because this request is investment-focused, the scenario model should be anchored to verifiable exclusivity and competitor counts. Those inputs are not available in this environment.

Base-case economics in the class (structural, not asset-specific)

For older opioid-combination products, the practical base case often looks like:

continued decline or plateau in branded volume under generic penetration,
margin compression from wholesaler discounts and rebate pressure,
offsetting gains from contracted access and stable formulary placement.

Key investment risks for FLUOCET

1) Generic launch and substitution risk

High if patents/exclusivities are near term or weakly enforceable.
Immediate if Paragraph IV outcomes remove barriers.

2) Opioid regulatory and payer controls

Utilization management and enforcement can reduce addressable volume.
Label changes can restrict use, affecting physician prescribing.

3) Supply continuity and compliance risk

Opioid manufacturing is compliance-sensitive.
Supply disruptions can cause lost market access that is hard to regain.

4) Litigation and product-liability risk

Class-wide opioid litigation increases cost and settlement probability.
Any product-specific vulnerabilities can accelerate margin erosion.

Key upside levers for FLUOCET holders

1) Remaining listed IP that blocks or delays generics

Formulation or method-of-use claims can matter if they are enforceable against generic product designs.

2) Contracting and formulary positioning

Sustained coverage can stabilize volumes even under generic pressure.

3) Manufacturing cost-down

Scale and process improvements can protect contribution margin.

Key Takeaways

FLUOCET’s investment case is primarily a reimbursement, competition, and timing model rather than an IP-led growth story.
The decisive factor is the remaining enforceable US patent and Orange Book exclusivity status tied to FLUOCET’s exact NDA/strength and current generic entry history.
Without Orange Book listing details (patent numbers, expiration dates, exclusivity codes) and current litigation/Paragraph IV events, a decision-grade exclusivity and entry-risk forecast cannot be produced.

FAQs

Does FLUOCET face REMS or heightened FDA labeling restrictions for opioids?
What drives gross-to-net erosion for hydrocodone/ibuprofen combination products once generics launch?
How do prior authorization and quantity limits typically affect opioid analgesic demand in commercial formularies?
What manufacturing risks most commonly disrupt supply of opioid-containing solid oral products?
How quickly do payers move to formulary substitution after first-ANDA approvals for opioid combination analgesics?

References

(No sources cited because FLUOCET-specific Orange Book status, patent numbers, exclusivity dates, FDA approval identifiers, and litigation records are not provided in the prompt.)

US Patents:	0
Applicants:	1
NDAs:	1

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