ERZOFRI Drug Patent Profile

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

Erzofri is a drug marketed by Luye Innomind Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has nine patent family members in eight countries.

The generic ingredient in ERZOFRI is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

DrugPatentWatch^® Generic Entry Outlook for Erzofri

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 24, 2039. This may change due to patent challenges or generic licensing.

There are five tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ERZOFRI

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	305
DailyMed Link:	ERZOFRI at DailyMed

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

NDA:

216352

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*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.

Pharmacology for ERZOFRI

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ERZOFRI

ERZOFRI is protected by four 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
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-001	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-002	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-005	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-006	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-006	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-001	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-002	Jul 26, 2024		RX	Yes	Yes

International Patents for ERZOFRI

When does loss-of-exclusivity occur for ERZOFRI?

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

Australia

Canada

European Patent Office

Japan

New Zealand

Russian Federation

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 ERZOFRI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018354431
Canada	3077224
European Patent Office	3700531
Spain	3036965
Japan	2021501200
Japan	7337080
New Zealand	763573

Supplementary Protection Certificates for ERZOFRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	07C0044	France		PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0368388	SPC/GB07/065	United Kingdom		PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0904081	SPC/GB11/044	United Kingdom		PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
0904081	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304

Last updated: July 25, 2026

ERZOFRI market dynamics and financial trajectory: pricing, demand drivers, launch timing, payer behavior, and competitive pressure

ERZOFRI is not a uniquely identifiable, FDA-approved pharmaceutical brand in publicly citable regulatory or commercial datasets through 2025-08 based on standard INN-to-brand and Orange Book/NDC crosswalks. Without an unambiguous active ingredient, sponsor/MAH, dosage form, and FDA application listing, the market size, unit trajectory, pricing, payer coverage, and financial outlook cannot be determined with the precision required for investment and litigation-grade patent/market analysis.

What drug is ERZOFRI, what is the active ingredient, and which company markets it?

No complete, verifiable mapping from “ERZOFRI” to:

• an FDA label name,
• an active ingredient (INN or USAN),
• an NDC/Gateway listing,
• an Orange Book entry, or
• a sponsor (MAH) is available from the information provided.

Is ERZOFRI a brand, a biosimilar, or a generic trade name?

The name alone does not resolve to a single product identity suitable for market modeling (single-agent vs combination, oral vs injectable, dosing schedule, and indication mix materially change revenue and payer dynamics).

What indications does ERZOFRI have in the FDA label?

Indication mix determines:

• demand elasticity,
• prior authorization and step edits,
• specialty vs hospital channel allocation,
• and competitive substitution risk.

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What are the key market drivers for ERZOFRI demand and adoption?

Because the product identity (active ingredient, indication, and formulation) is not determined, the major adoption drivers cannot be tied to ERZOFRI specifically.

Payer coverage and utilization management: what drives net price for ERZOFRI?

Net revenue depends on:

• formulary placement tier,
• rebates and discounts,
• utilization management (PA, quantity limits),
• and center-of-excellence or specialty channel carve-outs. These require payer-contract granularity for the exact molecule and labeled use.

Site-of-care and channel: hospital vs retail specialty vs specialty pharmacy

A molecule’s infusion vs oral profile shifts:

• WAC vs ASP dynamics,
• claim routing,
• and contracting structures. ERZOFRI’s dosage form and administration route are not specified.

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When did ERZOFRI launch, when did it peak, and what does the sales ramp look like?

A financial trajectory requires:

• first commercial date or FDA approval date for the US NDA/BLA,
• subsequent indication expansions,
• and quarterly sales data by product. No authoritative launch timeline or sales series for “ERZOFRI” is producible from the supplied information.

What is ERZOFRI’s FDA approval and first commercial shipment timeline?

Without the FDA application reference and label date, exclusivity and adoption modeling cannot be anchored.

Do sales reflect expansion indications or only initial label?

Indication-dependent growth cannot be inferred without knowing the label scope.

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How does ERZOFRI pricing work: WAC vs ASP, discounts, and rebate pressure?

Pricing and financial trajectory are molecule- and class-dependent (dose, regimen, comparator set, and severity of utilization management). ERZOFRI’s pricing inputs (WAC/ASP, rebate rate, payer net price) cannot be computed without product identity.

Is ERZOFRI facing biosimilar or generic substitution?

Substitution risk requires:

• whether the drug is biologic or small molecule,
• listing in the Orange Book (for generics) or BLA reference standards (for biosimilars),
• and the exclusivity/patent expiration profile tied to the specific reference product.

Which competitors anchor the formulary for ERZOFRI patients?

Comparator selection depends on indication and line of therapy. Without that mapping, competitive dynamics cannot be stated.

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What patent and exclusivity timeline governs ERZOFRI’s revenue durability?

Revenue durability is constrained by:

• regulatory exclusivity (NCE/NBEs, 5-year, 3-year, orphan if applicable),
• pediatric exclusivity,
• and Orange Book patent expiry plus any injunction/reformulation barriers. No product identity means no patent estate can be enumerated.

When does ERZOFRI lose exclusivity, and what do Paragraph IV filings signal?

This requires an Orange Book table with listed patents and their expiration dates, plus any ANDA Paragraph IV litigation filings.

How strong is the patent estate for ERZOFRI and what barriers exist for generics?

Barrier analysis needs:

• claims scope (composition, method of use, formulation, manufacturing),
• prosecution history events,
• and any adverse court rulings.

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What litigation and settlement risks affect ERZOFRI’s commercial future?

Paragraph IV and biosimilar litigation drives:

• entry timing,
• damages exposure,
• and settlement-triggered “at-risk” windows. No ERZOFRI-specific case docket can be tied to a defined reference product from the provided information.

Which companies are challenging ERZOFRI and what are the entry dates?

Requires ANDA/BLA challenge identifiers and the FDA and court case timeline.

What settlement terms would be material for ERZOFRI revenue protection?

Settlement terms are fact-specific (launch dates, design-arounds, non-marketing covenants, royalties).

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What is ERZOFRI’s FDA status and Orange Book listing status?

This section cannot be completed without the product’s FDA application identifier and Orange Book reference name.

Is ERZOFRI listed in the Orange Book for generic substitution eligibility?

Orange Book listing determines the legal substitution environment for ANDAs.

Does ERZOFRI have exclusivity tied to a reference NDA/BLA?

Exclusivity is calculated from regulatory milestones. Product identity is required.

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How does ERZOFRI compare commercially with closest-in-class drugs?

A defensible competitive comparison requires:

• the therapeutic class,
• indication,
• dosing regimen,
• clinical differentiation metrics,
• and net-price position. No defined ERZOFRI reference product is available.

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What generic entry risks exist for ERZOFRI and how would they impact revenue?

Generic and biosimilar impacts depend on:

• patent expiry and injunction status,
• reformulation hurdles (line extension vs true composition),
• and market access switching friction. These inputs require the exact drug identity.

What is the expected price erosion curve after generic entry?

Price erosion is class- and contracting-dependent. Without ERZOFRI’s molecule and payer profile, the curve cannot be specified.

What market segments would be most at risk (commercial vs Medicare vs Medicaid)?

Segment risk depends on:

• formulary uptake,
• member mix,
• and MAC/plan contracting rules.

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Geographic rollout dynamics: does ERZOFRI drive revenue internationally or only US?

International revenue requires:

• EMA/UK assessment,
• registration dates,
• and pricing/HTA decisions. No product identity means no international regulatory track can be mapped.

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Market strategy and licensing: what deal structures apply to ERZOFRI?

Licensing and partnering logic hinges on whether ERZOFRI is:

• owned in-house,
• partnered with a specialty distributor,
• or subject to co-promotion/revenue share. No company identity is provided.

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Key Takeaways

• “ERZOFRI” cannot be mapped to a single FDA-approved reference product with an identifiable active ingredient, sponsor, dosage form, or label from the information supplied, so market sizing, pricing trajectory, competitive landscape, patent/exclusivity constraints, and revenue outlook cannot be produced to a litigation- and investment-grade standard.
• A complete market dynamics and financial trajectory assessment requires an unambiguous product identity (active ingredient and FDA reference name) to pull Orange Book status, exclusivity timelines, and commercial/regulatory milestones.

FAQs

1. What is the FDA reference name for ERZOFRI and how does it map to Orange Book listings?
2. What is ERZOFRI’s labeled indication mix and how does that drive payer coverage and utilization management?
3. Is ERZOFRI a biologic or small molecule, and what biosimilar or generic substitution risks exist?
4. What is the expected revenue impact if an ANDA challenges ERZOFRI and triggers early entry?
5. How do net price and rebate dynamics for ERZOFRI compare with closest-in-class drugs in the same therapeutic segment?

References (APA)

No citable sources can be listed because no verified ERZOFRI product identity (active ingredient/FDA reference name) is available from the provided information.