INREBIC Drug Patent Profile

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

Inrebic is a drug marketed by Bristol-myers and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty patent family members in forty-two countries.

The generic ingredient in INREBIC is fedratinib hydrochloride. One supplier is listed for this compound. Additional details are available on the fedratinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Inrebic

Inrebic was eligible for patent challenges on August 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 INREBIC

International Patents:	120
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	4
Patent Applications:	129
Drug Prices:	Drug price information for INREBIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INREBIC
What excipients (inactive ingredients) are in INREBIC?	INREBIC excipients list
DailyMed Link:	INREBIC at DailyMed

See drug prices for INREBIC

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

NDA:

212327

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 INREBIC

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Joseph Jurcic	Phase 1
Bristol-Myers Squibb	Phase 2

See all INREBIC clinical trials

Paragraph IV (Patent) Challenges for INREBIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INREBIC	Capsules	fedratinib hydrochloride	100 mg	212327	1	2023-08-16

US Patents and Regulatory Information for INREBIC

INREBIC is protected by five US patents and one FDA Regulatory Exclusivity.

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
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes			Y
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes				Y
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes

International Patents for INREBIC

When does loss-of-exclusivity occur for INREBIC?

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

Australia

Brazil

Denmark

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Norway

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

Ukraine

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 INREBIC around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010363329
Australia	2011323108
Brazil	112013011184
Canada	2816710
Canada	2816957

Supplementary Protection Certificates for INREBIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	301104	Netherlands		PRODUCT NAME: FEDRATINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN FARMACEUTISCH AANVAARDBAAR HYDRAAT DAARVAN, IN HET BIJZONDER FEDRATINIBDIHYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/20/1514 20210209
1951684	122021000023	Germany		PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER EIN PHARMAZEUTISCH UNBEDENKLICHES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 20210208
1951684	LUC00204	Luxembourg		PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209
1951684	PA2021509	Lithuania		PRODUCT NAME: FEDRATINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA FARMACINIU POZIURIU PRIIMTINAS JO HIDRATAS, YPAC FEDRATINIBO DIHIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/20/1514 20210208
1951684	2021C/513	Belgium		PRODUCT NAME: FEDRATINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN HYDRATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE DICHLORHYDRATE DE FEDRATINIB MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209

Inrebic (fedratinib) market dynamics and financial trajectory: sales trends, uptake drivers, pricing exposure, and patent/competition risk

Last updated: July 30, 2026

Fedratinib (Inrebic) is a late-stage JAK2 inhibitor used for myelofibrosis (MF), with market performance tied to (1) hematology guideline adoption, (2) payer coverage and price tolerance in the US, (3) channel inventory discipline and specialty pharmacy throughput, and (4) competitive pressure from other MF agents. Financial trajectory has tracked launch maturity and ongoing penetration in intermediate-2 and high-risk primary and secondary MF populations, with risk now skewed toward future line-of-therapy shifts and label or evidence expansion for competing JAK inhibitors and combination strategies.

Key commercial facts to anchor the revenue story

• Product: Inrebic (fedratinib), oral JAK2 inhibitor
• Indications: Intermediate-2 or high-risk primary or secondary MF, including post–polycythemia vera (post-PV) MF and post–essential thrombocythemia (post-ET) MF (US labeling)
• Manufacturer: Celgene/Bristol Myers Squibb (commercial ownership in the US during the current fedratinib sales period)
• Economic focus: specialty distribution, high specialty per-patient cost, payer-driven prior authorization, and pull-through from MF clinics

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What drives Inrebic (fedratinib) market uptake in myelofibrosis?

Answer (drivers): Uptake depends on MF patient routing into JAK inhibitor care, guideline placement of fedratinib relative to ruxolitinib and other agents, tolerability (notably GI adverse events risk management), and payer coverage rules that determine whether patients get early access versus post-failure positioning.

Uptake drivers across the MF treatment pathway

• Line-of-therapy placement: Inrebic adoption tends to improve when it is treated as an option after ruxolitinib intolerance or inadequate response, and when clinical evidence supports use in broader risk segments.
• Safety management and persistence: The willingness of MF prescribers to keep patients on therapy affects net revenue through treatment duration and dose intensity. GI risk management and dose modifications are practical determinants of persistence.
• Specialty pharmacy and distribution economics: For oral oncology drugs, throughput through specialty pharmacies and timely fulfillment drive initial scripts and refill continuity.
• Payer access mechanics: Step edits, prior authorization, and quantity limits influence conversion of prescriptions into filled demand. In practice, payer behavior can shift demand from new starts to switch therapy.

What is the main competitive reference in MF?

In the US, market perception for fedratinib is dominated by comparison to:

• Ruxolitinib (Jakafi, JAK1/2) as the established anchor
• Other MF JAK inhibitors and next-line options where available, including agents with different tolerability and response profiles

Competitors’ formulary status directly shapes Inrebic’s share of MF managed-care demand.

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How has Inrebic’s financial trajectory evolved since launch?

Answer (trajectory): Inrebic’s revenue curve is typical of an oncology oral launch: initial uptake, then plateau or slower growth as payer penetration saturates and competitive switching sets in, followed by reacceleration only if label expansion, stronger comparative positioning, or reduced payer friction occurs.

Launch-to-maturity pattern for oral oncology

• Early period: demand concentrated in high-need MF specialty centers; growth influenced by initial payer coverage and prescriber learning curves.
• Mid period: revenue increasingly depends on switch patients and persistence in treated cohorts; marginal growth requires formulary expansion or improvements in access criteria.
• Late period: risk shifts toward displacement by competitors in later lines, plus lifecycle pressure from new MF mechanisms and combination regimens.

What metrics best track the commercial trajectory

Even when total revenue is not directly disclosed at line item level, the trajectory is observable through:

• Net sales direction vs. specialty pharmacy fill volumes
• Number of treated patients and switch rates from first-line JAK therapy
• Dose continuity (adherence and dose modification patterns)
• Average net price and contract rate changes (rebates, discounts, and payer-specific dynamics)

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When does Inrebic face pricing and payer pressure, and how does it affect net sales?

Answer (timing and impact): Price pressure typically accelerates around (1) stronger competitor formulary adoption, (2) large payer renegotiations, (3) patent-cost or exclusivity transitions that trigger earlier payer planning, and (4) contracting changes tied to real-world utilization.

Net price sensitivity in specialty oncology

• Contracting and rebates: US net revenue is highly sensitive to rebate structures tied to managed care growth and outcomes benchmarks.
• Prior authorization hurdles: payer rules can slow new starts even when clinical demand is stable, shifting activity to switch populations.
• Formulary tiering: moving from preferred to non-preferred tiers can reduce script conversion and refill stability, leading to revenue deceleration.

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What competitive landscape risks exist for Inrebic (fedratinib) in myelofibrosis?

Answer (risk): The largest risks are formulary displacement by other MF agents, line-of-therapy reclassification due to emerging efficacy data, and payer preference shifts driven by comparative safety and total-cost considerations.

Displacement mechanisms that hit revenue

• Switch dynamics: competitors can capture switch patients if they are preferred on formulary or have better persistence outcomes in real-world practice.
• Step therapy: requiring failure of a comparator can reduce Inrebic first access and concentrate it to later switch.
• Perceived tolerability tradeoffs: adverse event management affects persistence, and persistence drives net sales.

Growth opportunities that can offset displacement

• Broader evidence in risk subgroups can expand eligible patient routing
• Improved patient management protocols can increase persistence and reduce treatment interruption rates
• Contracting gains (preferred tier placement) can reverse deceleration

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What patents and exclusivity issues affect Inrebic’s commercial runway?

Answer (core exclusivity logic): Inrebic’s near-to-mid term revenue protection is anchored by composition, formulation, and method-of-use patent coverage plus any pediatric or regulatory exclusivity. The practical commercial risk arises when generic or branded “authorized” competitors pressure pricing through formulary and reimbursement changes.

How to think about “runway” for Inrebic

• Regulatory exclusivity: governs branded competition timing until exclusivity expires for new chemical entities or new indications (depending on labeling history).
• Orange Book patent listings: govern Paragraph IV and non-infringing generic entry strategies.
• Litigation posture: settlement terms can create “effective” launch dates even if some patents remain listed.

Patent estate relevance to market dynamics

As exclusivity nears, payers often pre-plan:

• earlier formulary inclusion of competitors
• expanded coverage for anticipated generics or authorized alternatives
• intensified rebate negotiations for incumbents These behaviors can compress net price before actual loss of exclusivity, pulling forward revenue pressure.

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What generic entry risks exist for Inrebic (fedratinib)?

Answer (risk profile): Generic risk is typically concentrated around the expiration of key Orange Book-listed patents for the branded drug substance or key formulation attributes, combined with litigation outcomes that can delay or accelerate entry.

Generic entry pathway

• ANDA filing timing: Paragraph IV filings can indicate the expected carve-outs and the patents likely to be attacked.
• 30-month stay: can delay approval, but settlement agreements can shorten or restructure timelines.
• Design-around attempts: formulation and method-of-use differences can prolong practical barriers.

Why this matters for revenue now

Even before launch, the market prices in expected competition. Brand companies often respond with:

• increased contracting intensity
• patient support programs
• lifecycle extension efforts (new dose forms or line extensions, if available)

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What formulations are protected for Inrebic, and how does that affect manufacturing IP barriers?

Answer (manufacturing barrier): IP barriers are stronger when formulation or process patents cover critical attributes, such as solid-state forms, stability, or manufacturing processes tied to bioavailability.

Formulation patent categories that can block generic equivalence

• Solid-state form patents (polymorphs, hydrates/solvates)
• Controlled-release or stability-linked excipient compositions (if applicable to the commercial product form)
• Manufacturing process patents that affect purity, particle size distribution, or impurity profiles

Even with ANDA bioequivalence, these barriers can drive litigation and delay market entry.

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What patent litigation affects Inrebic’s competitive timeline?

Answer (timeline driver): Litigation affects when a generic can launch without infringement exposure, often through:

• court findings on patent validity or infringement
• settlement agreements with agreed entry dates
• licensing arrangements where a generic product can launch under terms

Litigation impact on market behavior

• Settlement = predictable entry: increases payer switching behavior and competitor negotiation intensity.
• Ongoing litigation: prolongs uncertainty and can delay payer change until risk clarity emerges.

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What is the FDA and Orange Book status of Inrebic?

Answer (status use-case): Orange Book listings determine which patents can be used for Paragraph IV challenges and thus underpin the generic entry calendar that drives payer and brand contracting behavior.

How buyers use Orange Book for commercial modeling

• Identify key listed patents with earliest expiration
• Map ANDA-related stays or injunction risks
• Model effective launch date based on litigation and settlement patterns

(For an exact patent-by-patent status, a live Orange Book pull is required; this response does not include patent identifiers or expiration dates.)

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How does Inrebic compare with Jakafi (ruxolitinib) in market positioning and revenue exposure?

Answer (comparative dynamic): Ruxolitinib’s market power is shaped by formulary entrenchment and broader payer comfort, while fedratinib’s market share depends on being a preferred switch or an appropriate alternative based on tolerability, clinical response, and payer policy.

Competitive positioning that affects revenue

• Formulary preference: if ruxolitinib is preferred, fedratinib growth depends on non-covered ruxolitinib scenarios or clinical reasons to switch.
• Persistence: higher persistence with one agent can shift share over time even when initial script conversion is similar.
• Safety protocols: practical management of adverse events can determine whether patients remain on therapy and sustain revenue per treated patient.

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Revenue exposure scenarios for Inrebic: what happens if competition accelerates?

Answer (scenario framing): Revenue is most exposed to (1) earlier loss of preferred formulary status, (2) switch displacement into competitors, and (3) net price compression from intensifying rebate pressure once the market prices in exclusivity risk.

Scenario logic used by commercial teams

• Base case: stable MF patient routing to JAK inhibitors with gradual share shifts
• Downside: faster displacement from payer formulary changes, combined with increased switching to competitors and lower persistence
• Upside: improved payer access, stronger persistence outcomes, and evidence-driven expanded patient eligibility

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Key Takeaways

• Inrebic’s market dynamics track MF treatment routing, payer access friction, and persistence, not just clinical efficacy headlines.
• Financial trajectory follows a launch-to-maturity pattern: initial uptake, then slower growth as switching and formulary penetration dominate.
• Commercial risk is concentrated in competitor displacement, rebate and net price compression, and future exclusivity/patent-driven entry expectations.
• Effective revenue runway depends on Orange Book-linked patent timelines and litigation outcomes that influence payer planning and brand contracting behavior.
• Real-world adoption is sensitive to adverse event management and specialty channel performance, which directly affect duration-on-therapy and net sales.

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FAQs

1. How do specialty pharmacy fill rates translate into Inrebic net sales momentum in the US?
2. What payer coverage criteria most often determines whether Inrebic is chosen as first switch after ruxolitinib?
3. How do adverse event management protocols for fedratinib influence real-world persistence and revenue per patient?
4. What indicators show early formulary displacement risk for Inrebic before competitors capture managed-care share?
5. How do Paragraph IV filings and settlement agreements typically change branded pricing strategy for fedratinib?

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References

1. Bristol Myers Squibb. Inrebic (fedratinib) prescribing information. FDA.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. FDA. Drug trial snapshots and related labeling information for fedratinib.

DrugChatter Q&A for INREBIC

Inrebic approval south korea?
Inrebic synthesis patent targegen?
Inrebic fedratinib synthesis patent?
Inrebic prescribing information?
Is inrebic used for myelofibrosis?