ILLUCCIX Drug Patent Profile

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

Illuccix is a drug marketed by Telix and is included in one NDA. There is one patent protecting this drug.

This drug has forty-six patent family members in nineteen countries.

The generic ingredient in ILLUCCIX is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.

DrugPatentWatch^® Generic Entry Outlook for Illuccix

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 28, 2035. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ILLUCCIX

International Patents:	46
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Applications:	113
Drug Prices:	Drug price information for ILLUCCIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILLUCCIX
What excipients (inactive ingredients) are in ILLUCCIX?	ILLUCCIX excipients list
DailyMed Link:	ILLUCCIX at DailyMed

See drug prices for ILLUCCIX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ILLUCCIX

NDA:

214032

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ILLUCCIX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Grand Pharmaceutical (China) Co., Ltd.	Phase 3
Telix International Pty Ltd	Phase 3
BAMF Health	Early Phase 1

See all ILLUCCIX clinical trials

US Patents and Regulatory Information for ILLUCCIX

ILLUCCIX is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032-001	Dec 17, 2021		RX	Yes	Yes

International Patents for ILLUCCIX

When does loss-of-exclusivity occur for ILLUCCIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Belgium

Brazil

Canada

China

Denmark

European Patent Office

France

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

South Africa

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ILLUCCIX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015309187
Australia	2015309188
Australia	2020220193
Australia	2020220194
Australia	2022202346
Australia	2022202439

Last updated: June 15, 2026

Iluccix (Gat et al.) Market Dynamics and Financial Trajectory: Pricing, Uptake, Competition, and IP/Regulatory Risk

Iluccix’s market dynamics and financial trajectory depend on three drivers: (1) whether it is positioned as a fully differentiated product or as a late-cycle competitor inside an established therapeutic segment, (2) the timing and enforceability of its Orange Book and related IP estate, and (3) the probability of FDA pathway-contested entry (ANDA and, where applicable, 351(k) for biologics). On the evidence available here, a complete, decision-grade assessment cannot be produced because Illuccix’s active ingredient, labeled indication(s), route/dosage form, manufacturer(s), and FDA/Orange Book status are not provided.

If those items are not known, any attempt to quantify launch timing, forecast revenues, estimate gross-to-net pressure, map patent expiries, or model Paragraph IV and settlement outcomes would be speculative, and therefore not suitable for high-stakes R&D, licensing, litigation, or investment use.

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What is Illuccix and what therapeutic segment does it compete in?

Featured-snippet answer: A market-dynamics and financial model requires Illuccix’s active ingredient and indication; without them, competitive set definition is not possible.

Which active ingredient and formulation is Illuccix?

• Market sizing, pricing benchmarks, and gross-to-net normalization change materially with:
  • molecule class (small molecule vs biologic),
  • administration (oral, injectable, infusion, inhaled, topical),
  • dosing frequency and titration requirements,
  • administration setting (hospital vs outpatient vs self-administered).

Which indication(s) drive demand?

• Indication impacts:
  • eligibility (diagnostic criteria and line of therapy),
  • prescriber mix,
  • payer coverage hurdles,
  • seasonal or guideline-driven demand cycles.

Who manufactures Illuccix and who is the commercial owner?

• Revenue trajectory depends on:
  • territory and payer contract capability,
  • field force maturity,
  • channel strategy (buy-and-bill vs pharmacy benefit).

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How fast does Illuccix uptake typically look like, and what determines speed?

Featured-snippet answer: Uptake is determined by formulary access, reimbursement, clinician adoption, and switching friction relative to current standard of care.

Key uptake determinants

• Formulary position: preferred vs non-preferred tier placement.
• Net price trajectory: discounting, rebates, and contracting structure.
• Switching friction: whether payers require prior authorization or step therapy.
• Clinical adoption: whether guidelines or consensus pathways include it early.
• Distribution channel: specialty pharmacy vs medical benefit.

What role does evidence depth play?

• Uptake generally accelerates when:
  • comparative trials show clinically meaningful endpoints versus incumbents,
  • endpoints align to payers’ coverage criteria,
  • safety profile reduces monitoring burden.

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What pricing and gross-to-net pressures govern Illuccix revenue?

Featured-snippet answer: Gross-to-net is shaped by payer mix, contracting leverage, and the competitive intensity in the molecule’s class.

Pricing framework used for revenue trajectory modeling

• Launch-to-stabilization: list price may hold while net price declines via rebates and increased contracting pressure.
• Payer mix drift: commercial vs Medicare vs Medicaid mix changes with adoption.
• Indication expansion or limitation: additional label breadth can increase demand but also invite price competition.

Competitive pricing benchmarks needed

• A credible model requires at least:
  • average selling price (ASP) or WAC,
  • PBM benchmarks in the same class,
  • acquisition cost/benefit dynamics (if buy-and-bill).

Without the product’s class and indication, benchmark selection is not defensible.

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What does Illuccix’s financial trajectory depend on: launch year, channel, and cost structure?

Featured-snippet answer: Revenue trajectory depends on launch timing into formulary cycles, channel economics, and manufacturing scale readiness.

Revenue curve shape

Common shapes by market reality:

• Rapid early uptake when payer coverage is immediate and clinical switching is easy.
• Two-step uptake when hospital/clinic adoption leads first, with pharmacy benefit ramping later.
• Slow ramp when step edits and prior auth delay access.

Cost and margin trajectory

• COGS: depends on manufacturing yield, scale, and supply chain stability.
• Commercial spend: field force buildout, contracting headcount, and pharmacovigilance costs.
• Rebate and patient assistance: changes in response to competitive entries and payer pushback.

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

Featured-snippet answer: Patent strength and exclusivity duration are assessed through the Orange Book and related patent families tied to the approved NDA/BLA.

Orange Book and patent coverage map

A decision-grade estate map requires:

• Orange Book listing record (NDA/BLA holder),
• patent numbers (composition, method-of-use, formulation, and manufacturing),
• listed expiration dates,
• any pediatric exclusivity or other statutory extensions,
• exclusivity start/end dates (data and marketing exclusivity).

With no FDA identifier or Orange Book listing provided, a complete mapping is not possible.

How to interpret strength for business risk

• Composition of matter patents are typically higher impact.
• Method-of-use patents can shape switching even after some composition protection fades.
• Formulation/manufacturing patents can raise generic production or carve-out risk.

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When does Illuccix lose exclusivity: patent expiry vs data/marketing exclusivity?

Featured-snippet answer: The effective exclusivity window is the later of patent expiration and any statutory exclusivity protections.

Exclusivity timeline components to compute

• Patent expirations (composition/method/formulation).
• NDA/BLA data exclusivity (where applicable).
• Statutory marketing exclusivity for new products.
• Pediatric exclusivity extensions, if triggered.

No exclusivity dates can be stated without the specific FDA application and Orange Book record.

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What Paragraph IV ANDA risks exist for Illuccix generics?

Featured-snippet answer: ANDA litigation risk depends on whether ANDAs have been filed against the listed patents and whether the applicant seeks “carve-out” designs.

What Paragraph IV indicators to track

• Any ANDA filings referencing Illuccix’s NDA.
• Listed patents challenged (key vs peripheral patents).
• Trial timing and court rulings.
• Settlement and consent decree terms (where public).

Without the NDA number and Orange Book patent list, Paragraph IV risk cannot be quantified.

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Is there biosimilar risk for Illuccix under 351(k), and how does that change the financial forecast?

Featured-snippet answer: Biosimilar threat changes revenue dynamics through uptake curves and tendering in biologic-heavy indications.

Biologics-only mechanics

• Biosimilar interchangeability status can accelerate adoption.
• Tendering or contract re-bidding can cause abrupt revenue shifts.
• Switching policies can extend or shorten competitive ramp.

Whether Illuccix is a biologic is not established here, so biosimilar risk cannot be assessed.

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What formulations and delivery systems are protected for Illuccix?

Featured-snippet answer: Formulation and delivery patent coverage determines whether generics can enter “at-risk” with a non-infringing design.

Formulation patent categories to identify

• controlled release and dosing frequency claims,
• stabilization and excipient systems,
• device-integrated delivery systems,
• manufacturing process controls tied to product quality attributes.

A formulation IP map cannot be created without the product’s patent list and claims.

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What method-of-use or regimen patents restrict switching for Illuccix?

Featured-snippet answer: Method-of-use patents can block label-based substitution even when composition protection weakens.

Regimen restriction risk

• endpoint-defined dosing,
• patient subtype criteria,
• line-of-therapy combinations,
• monitoring requirements tied to claims.

Without knowing the indication(s) and claim landscape, this cannot be analyzed.

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Which companies are challenging Illuccix, and what does litigation history indicate?

Featured-snippet answer: Competitive pressure is shaped by challenger identity, challenge targets, and outcomes of prior settlements.

Litigation outcomes that influence financial trajectory

• court injunctions or narrow settlements,
• “early working” or launch-at-risk outcomes,
• licensing deal terms.

No litigation docket references are available here to map challengers or outcomes.

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How do settlement agreements affect generic or biosimilar launch timing for Illuccix?

Featured-snippet answer: Settlements can accelerate or delay entry through agreed design-arounds, dates, and royalty/licensing terms.

Settlement terms that matter financially

• agreed launch date,
• scope of product design (carve-outs),
• royalty base and rate,
• exclusivity covenants and ongoing supply restrictions.

No settlement information is available here.

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What is the FDA status of Illuccix (approval pathway, label scope, and exclusivity)?

Featured-snippet answer: FDA pathway and label scope determine the enforceable exclusivity set and the realistic market ceiling.

Information required for an FDA-driven model

• NDA/BLA submission type (505(b)(1), 505(b)(2), 351(a), etc.).
• Approval date.
• Label indication set and any subsequent label expansions.
• Pediatric and other exclusivity triggers.

Without FDA identifiers and dates, no timeline can be stated.

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What is the Orange Book status of Illuccix and what does it imply for generic entry?

Featured-snippet answer: The Orange Book status is the practical map of patent barriers.

How Orange Book status translates into entry risk

• More patents with broad claims generally increase injunction risk.
• A mix of composition and method patents can force generic design work or carve-outs.
• Patent expiries clustered together can create “patent cliff” entry timing.

Orange Book status is not provided here, so implications cannot be stated.

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How does Illuccix compare with competing drugs, and where does it win or lose on adoption economics?

Featured-snippet answer: Competitive position is determined by comparative efficacy, safety monitoring burden, dosing convenience, and payer coverage alignment.

Competitive set elements needed

• Similar indication and line-of-therapy comparators.
• Dosing frequency and route.
• Administration setting and reimbursement channel.
• Pricing relationship to incumbents.

Without Illuccix’s active ingredient and indication, comparison is not possible.

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What generic launch scenarios exist for Illuccix, and what are the revenue impact ranges?

Featured-snippet answer: Revenue impact depends on whether entry occurs:

• via full label substitution at first-to-file,
• via design-arounds and carve-outs,
• via “at-risk” launch before final patent resolution,
• or via delayed entry after settlement.

No patent timeline, Orange Book listing, or FDA application data is available here to model scenarios.

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Geographic coverage: which markets drive the largest portion of Illuccix profits and why?

Featured-snippet answer: Profits concentrate where formulary coverage and reimbursement maturity are highest, typically US first if an FDA approval drives demand.

Regional dynamics that change financial trajectory

• US: PBM contracting and litigation environment.
• EU: EMA status, national pricing and tendering.
• UK: NICE impact (if applicable).
• Japan: reimbursement schedule and biologic tender dynamics.

No geography-specific commercialization data is provided.

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Manufacturing and IP barriers: can competitors produce a non-infringing version quickly?

Featured-snippet answer: IP barriers are practical only if they are tied to scalable manufacturing, formulation know-how, or device integration.

Manufacturing/IP interface to evaluate

• process patents that constrain manufacturing steps,
• stability and shelf-life claims linked to process inputs,
• device or delivery system claims that require proprietary components.

No product-specific manufacturing IP is included here.

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Key Takeaways

• A complete market-dynamics and financial trajectory for Illuccix cannot be produced without the product’s active ingredient, indication, manufacturer, FDA application details (NDA/BLA and approval date), and Orange Book listing.
• Once those inputs are established, a decision-grade analysis would map: exclusivity timelines, patent estate strength, ANDA/biosimilar risk, likely challenger set, settlement-driven launch timing, and revenue curve sensitivity to gross-to-net and market share.
• No quantified revenue forecast, patent expiry schedule, or litigation risk assessment can be stated from the information available.

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FAQs

1. What information determines whether Illuccix is most exposed to Paragraph IV generic entry versus design-around delays?
2. How does a method-of-use patent set change the likelihood of rapid substitution after patent expiration for a branded therapy?
3. What metrics best predict gross-to-net erosion for a new branded drug in its first 24 months?
4. How do buy-and-bill versus pharmacy benefit channels typically affect the speed of uptake for specialty therapies?
5. What factors most strongly shift biosimilar uptake curves when interchangeability is granted or contested?

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References

No sources were cited because Illuccix-specific FDA, Orange Book, patent, litigation, and commercial data are not provided in the prompt.