LITFULo Drug Patent Profile

When do Litfulo patents expire, and when can generic versions of Litfulo launch?

Litfulo is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight patent family members in forty-eight countries.

The generic ingredient in LITFULO is ritlecitinib tosylate. Two suppliers are listed for this compound. Additional details are available on the ritlecitinib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Litfulo

Litfulo will be eligible for patent challenges on June 23, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 3, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LITFULo

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
Drug Prices:	Drug price information for LITFULo
What excipients (inactive ingredients) are in LITFULo?	LITFULo excipients list
DailyMed Link:	LITFULo at DailyMed

See drug prices for LITFULo

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

Constraining patent/regulatory exclusivity:

9,617,258

NDA:

215830

Dosage:

CAPSULE;ORAL

^*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 LITFULo

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nice	PHASE2

See all LITFULo clinical trials

Pharmacology for LITFULo

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors Janus Kinase 3 Inhibitors Tyrosine Kinase Inhibitors

US Patents and Regulatory Information for LITFULo

LITFULo is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,617,258.

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
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes	12,077,533
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes	12,116,368			Y
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes	9,617,258		Y	Y

International Patents for LITFULo

When does loss-of-exclusivity occur for LITFULo?

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

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

El Salvador

Eurasian Patent Organization

European Patent Office

Finland

Georgia, Republic of

Guatemala

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 LITFULo around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3077395	PYRROLO[2,3-D]PYRIMIDINYLE, PYRROLO[2,3-B]PYRAZINYLE ET PYROLLO[2,3-D]PYRIDINYLE ACRYLAMIDES (PYRROLO[2,3-D]PYRIMIDINYL, PYRROLO[2,3-B]PYRAZINYL AND PYRROLO[2,3-D]PYRIDINYL ACRYLAMIDES)
Spain	2654051
Morocco	39092
Croatia	P20210770

Supplementary Protection Certificates for LITFULo

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3077395	122023000064	Germany		PRODUCT NAME: RITLECITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1755 20230915
3077395	2023C/544	Belgium		PRODUCT NAME: RITLECITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1755 20230918
3077395	202440002	Slovenia		PRODUCT NAME: RITLECITINIB OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1755/001-003; DATE OF NATIONAL AUTHORISATION: 20230915; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3077395	PA2023537,C3077395	Lithuania		PRODUCT NAME: RITLECITINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1755 20230915

LITFULO (furosemide) Market Dynamics and Financial Trajectory: Uptake, Pricing, Competition, and Exclusivity-Driven Revenue Risks

Last updated: June 9, 2026

LITFULO’s market trajectory is driven by (1) label and payer access versus existing loop diuretics, (2) whether LITFULO is positioned on an oral convenience, dose, or safety differentiation that changes switching behavior, and (3) the exclusivity and patent estate that controls generic and authorized-generic entry timing. Without LITFULO’s NDC-level details, FDA approval pathway, and Orange Book patent listing, a complete, accurate financial model and date-certain exclusivity schedule cannot be produced.

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Is LITFULO a branded furosemide product, and how does it compete against generics?

Featured snippet answer: Branded loop-diuretic products typically face rapid generic substitution unless LITFULO has a protectable formulation, method-of-use, or delivery advantage that meaningfully changes clinician or payer behavior.

Core dynamics for branded loop diuretics

Loop diuretics are mature, off-patent molecules in most markets, with pricing pressure from high-volume generic erosion. Market outcomes for any new brand depend on:

• Switchability: whether LITFULO is substitutable at the same dose strength and dosing schedule without clinical downside.
• Therapeutic inertia: whether hospitals and large ambulatory systems standardize on formularies that already list low-cost generics.
• Payer design: tiering, prior authorization rules, and step-edit protocols that favor generics.
• Dispensing economics: WAC-to-AWP and rebate structures that determine net price versus list price.

Competitive baseline

For LITFULO, the competitive set is determined by the specific active ingredient and dosage form that the FDA labels. In the absence of the exact LITFULO composition (salt, strength, formulation type), and without Orange Book entries tying the brand to particular protectable features, market share and forecast cannot be anchored to a defined comparator set.

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What are the key drivers of LITFULO uptake (prescribing, formularies, and switching)?

Featured snippet answer: Uptake is constrained by formulary placement, PBM rebate economics, and the degree to which LITFULO reduces cost of care versus generic loop diuretics.

Payer and formulary mechanics

Branded uptake in cardiovascular and nephrology diuretic use is usually constrained by:

• Preferred drug lists that already include generic furosemide.
• Net pricing pressure that compresses brand margins as rebates rise to win access.
• Patient category segmentation (for example, heart failure or renal disease subpopulations) where prescribers may consider branded options if there is meaningful tolerability or adherence benefit.

Clinician adoption thresholds

Clinicians adopt a new diuretic brand if it changes one of the following:

• Adherence (dosing frequency or ease)
• Safety profile (electrolyte management, tolerability in a defined setting)
• Onset/PK predictability (if formulation changes matter clinically)
• Administration (if there is an advantage in inpatient or outpatient workflows)

Without LITFULO’s label claims and formulation attributes, adoption drivers cannot be mapped to measurable uptake levers.

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What is LITFULO’s pricing trajectory and net sales risk under generic competition?

Featured snippet answer: Branded diuretic net sales typically decline rapidly after generic entry unless the brand’s net price remains protected by exclusivity, patient-specific differentiation, or manufacturer-funded access strategies.

How generic entry affects net sales

For loop diuretics, once generics are established:

• Volume shifts quickly toward lowest net cost alternatives.
• Rebates rise to defend contracting, driving down margins.
• Gross-to-net spreads widen if the brand keeps list price but must compete on net.

Key financial sensitivities

A credible financial trajectory needs:

• Net sales by quarter (or at least trailing annual totals)
• Market share vs. generic penetration
• Gross margin and rebate rates
• Channel mix (retail vs mail vs institutional)
• Impact of tendering and group purchasing

None of these metrics are supplied for LITFULO in the prompt, so a date-bound financial forecast cannot be constructed.

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When does LITFULO lose exclusivity, and what drives the timing of generic entry?

Featured snippet answer: Exclusivity loss is driven by the latest of patent expiration, regulatory exclusivity (if any), and any Orange Book-listed formulation or method patents that block specific generic formulations.

Exclusivity and patent estate architecture

For revenue durability, the relevant items are:

• Composition-of-matter expiration
• Formulation patents (if LITFULO has a distinct release profile, excipient system, or device-related attributes)
• Method-of-use patents (if label claims create a specific use that generics cannot practice without an FDA approval carve-out)
• Pediatric exclusivity and data exclusivity (only applicable if tied to FDA regulatory exclusivity frameworks and the actual approval history)

Without LITFULO’s FDA approval identifiers (application number, reference product, approval date, submission pathway) and Orange Book patent listings, a date-certain exclusivity timeline is not possible.

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How many patents protect LITFULO, and what is the likely generic design-around risk?

Featured snippet answer: Generic risk scales with (1) number of relevant Orange Book patents, (2) whether patents cover a generic-avoidable feature, and (3) whether litigation has already narrowed protectable scope.

Patent categories that matter for market blocking

LITFULO revenue risk is highest when multiple patents cover:

• Core formulation (release, particle engineering, permeability modifiers)
• Manufacturing methods with narrow generic workarounds
• Method of use that aligns with the label’s most prescribable indications

If LITFULO is simply a branded version of an off-patent molecule without unique protectable attributes, the estate likely has limited ability to delay generic competition.

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What is the Orange Book status of LITFULO (patent listings, expirations, and exclusivity)?

Featured snippet answer: Orange Book status determines what generic filers must address via paragraph IV certifications.

A complete Orange Book status requires:

• FDA sponsor name and active ingredient details
• NDCs tied to the NDA
• Listed patents with expiration dates and “drug substance,” “drug product,” and “method of use” classifications

No Orange Book listing details are provided in the prompt, so LITFULO’s exact Orange Book profile cannot be reported.

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Has LITFULO faced paragraph IV challenges or patent litigation, and what were outcomes?

Featured snippet answer: Paragraph IV certifications and litigation outcomes determine whether generic entry is delayed, design-arounded, or launched at risk.

Litigation factors that affect financial trajectory

• Settlement terms (license scope, payment size, time-to-launch)
• Court rulings (claim construction and invalidity)
• Design-around success (whether the generic avoids the protectable feature)
• Launch timing (automatic stay duration and any lift triggers)

No litigation or settlement facts are included in the prompt, so LITFULO-specific legal dynamics cannot be quantified.

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What generic entry risks exist for LITFULO across different strengths and dosage forms?

Featured snippet answer: Entry risk varies by strength and dosage form because different strengths can have separate NDCs and separate patent coverage.

Strength-by-strength exposure

Key determinants:

• Orange Book patent coverage by NDC
• Whether a generic can file bioequivalence across strengths
• Whether formulation patents protect only certain strengths

Without NDC-level and patent-by-NDC information, a strength-specific risk map cannot be built.

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How does LITFULO compare with other diuretic brands on efficacy, convenience, and payer access?

Featured snippet answer: Brand differentiation only sustains premium pricing if it changes measurable outcomes or reduces administration friction that payers can price into contracts.

Comparison dimensions

• dosing schedule convenience
• formulation differentiators (if any)
• tolerability and electrolyte profiles, if supported by the label
• inclusion in preferred formularies

No label and clinical differentiation details are provided for LITFULO.

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What does the FDA regulatory pathway imply for LITFULO market timing and exclusivity?

Featured snippet answer: The FDA approval pathway and regulatory history determine data exclusivity, patents that can be listed, and the likelihood of early generic substitution.

Data exclusivity and regulatory references

A correct market-timing analysis needs:

• NDA approval date and reference product relationships
• Whether the product obtained 5 years new clinical investigations exclusivity (if applicable)
• Whether method-of-use claims affect exclusivity

The prompt contains no FDA pathway history for LITFULO.

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Which companies are likely to commercialize generic or authorized-generic versions of LITFULO?

Featured snippet answer: Generic competitors are typically those that already manufacture and file on loop-diuretic products, but exact identification requires Orange Book “pending” and “certification” data and any known ANDA filers.

No ANDA filer list, court docket, or certification data is provided in the prompt.

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Market sizing and financial trajectory: what can be stated from the information provided?

Featured snippet answer: A data-backed financial trajectory cannot be produced without LITFULO-specific sales, pricing, and exclusivity/patent date inputs.

What a professional trajectory model would require (but is not provided here)

• Net sales history (monthly or quarterly)
• Prescriber and script share (TRx, scripts)
• Wholesale acquisition cost and net price evolution
• Channel mix and rebate structure
• Patent expiration calendar and Orange Book linkage
• Litigation and settlement timeline
• Generic launch calendar for the relevant active ingredient, dose, and formulation

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Key Takeaways

• LITFULO’s financial trajectory in a mature loop-diuretic category hinges on whether it has enforceable exclusivity tied to product/formulation or label-protected use, and on the timing of generic entry.
• Branded diuretic brands face rapid net price compression under generic substitution unless payer access and clinically meaningful differentiation sustain demand.
• A date-certain exclusivity and patent-driven revenue forecast for LITFULO requires FDA Orange Book listings and regulatory/patent timelines; these are not included in the prompt, so market and financial specifics cannot be stated accurately.

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FAQs

1. How does Orange Book patent coverage by NDC change generic launch timing for branded diuretics?
2. What settlement structures most often determine when a generic can launch “at risk” versus after a stay?
3. How do PBM rebate strategies affect a branded loop diuretic’s net sales after generic availability?
4. Which formulation patent types (release, particle engineering, excipient systems) are hardest for generics to design around?
5. How does the FDA approval pathway (505(b)(2) vs NDA) affect the exclusivity stack for a diuretic brand?

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References

(No sources were cited because the prompt did not include LITFULO identifiers or any FDA/Orange Book/patent/litigation facts to cite.)