PEMAZYRE Drug Patent Profile

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

Pemazyre is a drug marketed by Incyte Corp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch^® Generic Entry Outlook for Pemazyre

Pemazyre was eligible for patent challenges on April 17, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 3, 2040. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PEMAZYRE

International Patents:	171
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	7
Patent Applications:	3,971
Drug Prices:	Drug price information for PEMAZYRE
What excipients (inactive ingredients) are in PEMAZYRE?	PEMAZYRE excipients list
DailyMed Link:	PEMAZYRE at DailyMed

See drug prices for PEMAZYRE

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

NDA:

213736

Dosage:

TABLET;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 PEMAZYRE

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

Sponsor	Phase
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	Phase 2
Incyte Biosciences International Sàrl	Phase 2
Tianjin Medical University Cancer Institute and Hospital	Phase 2

See all PEMAZYRE clinical trials

Pharmacology for PEMAZYRE

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for PEMAZYRE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEMAZYRE	Tablets	pemigatinib	4.5 mg, 9 mg and 13.5 mg	213736	1	2024-04-17

US Patents and Regulatory Information for PEMAZYRE

PEMAZYRE is protected by ten US patents and two FDA Regulatory Exclusivities.

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
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes			Y	Y
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-002	Apr 17, 2020		RX	Yes	No
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-002	Apr 17, 2020		RX	Yes	No

EU/EMA Drug Approvals for PEMAZYRE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Incyte Biosciences Distribution B.V.	Pemazyre	pemigatinib	EMEA/H/C/005266Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.	Authorised	no	no	yes	2021-03-26

International Patents for PEMAZYRE

When does loss-of-exclusivity occur for PEMAZYRE?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Morocco

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

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 PEMAZYRE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	091424
Argentina	117823
Argentina	122006
Australia	2013287176
Australia	2019200066
Australia	2020270520
Australia	2022291504

Supplementary Protection Certificates for PEMAZYRE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861595	PA2021519	Lithuania		PRODUCT NAME: PEMIGATINIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1535 20210326
2861595	301131	Netherlands		PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1535 20210329
2861595	LUC00222	Luxembourg		PRODUCT NAME: PEMIGATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595	CA 2021 00033	Denmark		PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1535 20210329
2861595	122021000054	Germany		PREVIOUS REPRESENTATIVE: UEXKUELL & STOLBERG PARTNERSCHAFT VON PATENT- UND RECHTSANWAELTEN MBB, 22607 HAMBURG, DE; PRODUCT NAME: PEMIGATINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; AUTHORISATION NO/DATE: EU/1/21/1535 20210326
2861595	2021C/536	Belgium		PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595	C02861595/01	Switzerland		PRODUCT NAME: PEMIGATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68143 13.07.2021

PEMAZYRE (pemigatinib) market dynamics and financial trajectory: sales drivers, exclusivity timeline, competitive threats, and revenue exposure

Last updated: July 26, 2026

Executive summary: Pemazyre (pemigatinib) is a niche, oncology targeted-therapy product driven by FGFR-altered cholangiocarcinoma and other FGFR-driven indications that are constrained by biomarker screening rates, resistance biology, and competitive entry from other FGFR inhibitors and SOC sequencing. Financial trajectory is tied to (1) growth in eligible patient populations identified through FGFR testing, (2) treatment persistence and dose intensity, (3) label expansion cadence, and (4) pricing and payer coverage in the US and major ex-US markets. Key downside risk is loss of exclusivity tied to the underlying patent estate and potential generic or follow-on inhibitor competition as later-line utilization becomes contested.

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What is Pemazyre (pemigatinib) used for, and how do those indications shape revenue?

Featured answer: Pemazyre revenue is primarily a function of uptake in FGFR1/2 rearranged or FGFR2 fusion cholangiocarcinoma after prior therapy, plus any subsequent line or biomarker-window expansions. Sales mix depends on how quickly treatment-naïve and previously treated subpopulations adopt FGFR testing and adopt pemigatinib versus competing FGFR inhibitors.

Core commercial indication(s) and revenue sensitivity

Pemazyre is positioned in FGFR-driven cancers, where market size is limited by:

• the fraction of tumors with actionable FGFR alterations
• time to diagnosis and ordering of FGFR testing
• clinician preference relative to other FGFR inhibitors
• line-of-therapy behavior (first vs later line)

Revenue sensitivity is highest to:

• incremental penetration of FGFR testing (real-world adoption)
• conversion from “eligible by genotype” to “treated with pemigatinib”
• discontinuation rates driven by progression, adverse events, and subsequent therapy selection

Mechanism and sequencing dynamics

Pemigatinib is an oral, ATP-competitive FGFR inhibitor. In practice, growth depends on:

• durability in real-world treatment settings (time on treatment)
• switching patterns after progression to other targeted agents, chemo, or immunotherapy
• how the emergence of next-generation FGFR inhibitors impacts first-pick status

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How fast is the FGFR biomarker test adoption changing Pemazyre demand?

Featured answer: Pemazyre demand follows the adoption curve of FGFR testing workflows in oncology centers. Sales typically track:

• ordering rates of FGFR assays
• payer coverage and turnaround times
• pathologist and oncologist familiarity with FGFR-driven therapeutic pathways

Real-world adoption constraints

Key operational factors that move the revenue needle:

• prevalence of comprehensive genomic profiling vs single-gene panels
• specimen type and adequacy rates (biopsy vs resection)
• reporting lags and treatment start delays
• payer prior authorization requirements for targeted therapy

Market segmentation where sales concentrate

Because FGFR-altered cholangiocarcinoma is relatively uncommon, commercial performance is concentrated in:

• high-volume hepatobiliary oncology centers
• tertiary referral networks
• regions with established molecular tumor board operations

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What market share does pemigatinib have versus other FGFR inhibitors?

Featured answer: Pemigatinib’s share is determined less by classwide category growth and more by its position in treatment sequencing versus other FGFR inhibitors and the speed at which clinicians shift among agents after resistance or adverse events.

Competitive set and substitution risk

Pemazyre faces competition from other FGFR-pathway inhibitors that target overlapping patient populations. Substitution drivers include:

• perceived efficacy in specific FGFR alterations
• tolerability profile and management of class toxicities (eg, ocular events, hyperphosphatemia)
• payer formulary placement by line of therapy
• contracting and rebate structures that influence net price

How competition typically affects financial trajectory

In niche targeted oncology:

• initial uptake can be rapid if testing is present and label is aligned
• growth can flatten as treatment becomes crowded and sequencing becomes protocolized
• incremental sales can shift toward competitors when they secure preferred positioning through trials, real-world evidence, or payer contracting

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What patents protect Pemazyre (pemigatinib), and when do they expire?

Featured answer: Patent protection for pemigatinib determines the timetable for generic or follow-on competition risk. The practical “exclusivity clock” is driven by the earliest composition-of-matter, formulation, and method-of-use patents, plus any FDA exclusivities that may delay generic substitution.

Patent estate structure that matters for revenue

For a branded targeted oncology drug, revenue risk usually emerges from:

• earliest composition-of-matter expiration (core active)
• downstream claims for formulations, dosing regimens, or patient selection
• method-of-use claims tied to biomarker-defined populations
• enforcement strength based on claim scope and litigation history

Exclusivity and revenue impact framing

When core active protection ends:

• generics may enter if they can avoid method-of-use and formulation blocks
• payers can push substitution depending on bioequivalence and labeling carve-outs
• branded sales compress via price erosion and switching

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When does Pemazyre face generic entry risk under Paragraph IV?

Featured answer: Generic entry risk typically accelerates in the window after earliest unexpired claims expire or are rendered non-infringing/non-valid. For US strategy, the critical catalyst is any Paragraph IV filing aligned to the Orange Book listed patents.

What to watch in the Orange Book

The risk map for pemigatinib is determined by:

• which patents are listed for the approved drug (active ingredient, formulation, method)
• the expiry dates of each listed patent
• any regulatory exclusivities listed alongside
• settlement outcomes that can lock in launch timing

Settlement dynamics

If Paragraph IV challenges lead to settlements:

• launch can be delayed by delayed-entry provisions
• at-risk launch windows can shift based on claim construction and court outcomes
• generic pricing pressure can come in waves depending on settlement terms and design-arounds

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What is the biosimilar or biologics risk for Pemazyre?

Featured answer: Biosimilar risk is not applicable in the traditional sense because pemigatinib is a small-molecule drug rather than a biologic.

Follow-on small-molecule competition

Instead, the realistic competitive threat is:

• generics of pemigatinib after patent and exclusivity barriers lapse
• follow-on branded small molecules targeting FGFR alterations
• combination regimens that reduce pemigatinib monotherapy share

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What formulations and dosing regimens are protected for Pemazyre?

Featured answer: Revenue-preserving IP barriers can include formulation or dosing-related patents that extend exclusivity beyond the earliest composition-of-matter.

Formulation patent categories

Formulation claims typically protect:

• specific tablet or capsule compositions
• film coating or excipient systems
• stability and dissolution characteristics
• manufacturing processes and impurity limits

Dosing and regimen patent categories

Method-of-use claims can cover:

• specific line-of-therapy usage
• biomarker-defined patient selection criteria
• dose-modification strategies for toxicity management

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What FDA regulatory status underpins Pemazyre’s sales trajectory?

Featured answer: Pemazyre’s commercialization is tied to its FDA approvals, labeling breadth, and any postmarketing label changes. Sales expand when indications broaden or when combination and sequencing acceptance grows with guideline uptake.

Regulatory milestones that affect adoption

Commercial impact typically aligns with:

• initial approval label that sets the first eligible cohort
• subsequent supplemental approvals that expand eligible patients
• safety label revisions that affect willingness to treat
• FDA guidance or clinical practice alignment that speeds protocolization

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How do payer coverage, pricing, and specialty pharmacy dynamics affect Pemazyre net sales?

Featured answer: Net sales depend on net price after rebates and patient assistance, with specialty channel execution controlling access.

Where net price is won or lost

Pemazyre sales can be pressured by:

• formulary placement by specialty pharmacy benefit managers
• step therapy and prior authorization rules
• contracting that favors competing FGFR inhibitors
• discounting tied to utilization benchmarks

Specialty pharmacy execution

Key performance drivers include:

• time to therapy start after diagnosis
• adherence and persistence tracking
• dose management programs that reduce discontinuations

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What does the financial trajectory look like by market stage: launch, plateau, and maturity?

Featured answer: Targeted oncology drugs with biomarker constraints typically show a launch-to-plateau pattern: early growth driven by physician adoption and testing ramp, followed by stabilization as the treatable pool saturates and competition narrows.

Launch phase dynamics

Sales are typically driven by:

• strong initial prescribing where label alignment matches clinical needs
• rapid initial uptake in referral centers
• payer adoption if prior authorization is manageable and net pricing is competitive

Maturity phase dynamics

Sales stabilize or decline when:

• treatment shifts to newer FGFR inhibitors or combination regimens
• class toxicities lead to discontinuation or lower dose intensity
• biomarker testing saturates in the most accessible centers
• generics or follow-on branded competitors approach exclusivity boundaries

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How does Pemazyre compare commercially with other FGFR therapies?

Featured answer: Pemazyre’s comparative performance depends on each drug’s label breadth, line-of-therapy positioning, and competitive differentiation by tolerability and perceived efficacy for specific FGFR alterations.

Comparison dimensions that drive market outcomes

• label population size (inclusion criteria and number of eligible biomarker groups)
• time-to-response and durability profiles in relevant settings
• adverse event burden and management protocols
• payer preference based on net cost and outcomes evidence
• combination trial read-through affecting sequencing

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What generic launch scenarios exist for pemigatinib, and what could they do to revenue?

Featured answer: Generic entry would likely trigger revenue compression via switching and net price erosion, with magnitude depending on which Orange Book patents remain enforceable and whether method-of-use claims block substitution.

Switching and substitution levers

• pharmacy switching policies within specialty networks
• prescriber substitution behavior
• patient support program influence
• payer incentives for generic uptake

Design-around risk

If a generic attempts design-arounds:

• they may avoid certain formulation claims but not necessarily method-of-use claims
• litigation could lead to partial settlement outcomes that limit launch or narrow labeling

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What patent litigation and settlements have historically affected branded oncology revenues like Pemazyre?

Featured answer: Branded oncology revenues are most exposed to litigation that either blocks generic launches through injunction or, conversely, leads to earlier-than-expected entry if courts narrow enforceability.

Litigation patterns that matter

Common litigation leverage points include:

• validity challenges to key claims
• non-infringement positions via design-around or labeling carve-outs
• claim construction outcomes that change launch timelines

Settlement-driven revenue timing

When settlements occur:

• launch is often delayed through controlled entry dates
• branded sales can extend into additional quarters or years depending on settlement terms

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Key Takeaways

• Pemazyre’s financial trajectory is primarily driven by biomarker-driven patient identification, treatment sequencing, and payer access dynamics in FGFR-altered oncology.
• Sales growth depends on real-world adoption of FGFR testing and clinician conversion from eligible genotype to treated patient.
• Competitive pressure from other FGFR inhibitors can shift preferred sequencing, reducing pemigatinib’s share even if the overall FGFR category grows.
• Generic and follow-on small-molecule competition risk is determined by the pemigatinib patent estate and the Orange Book listed patents, with Paragraph IV challenges as the US-specific launch catalyst.
• Revenue downside is most acute when exclusivity barriers lapse and when payer contracting favors lower-cost alternatives.

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FAQs

1. How do FGFR testing turnaround times affect pemigatinib treatment starts and sales?
2. What factors determine whether pemigatinib is prioritized over other FGFR inhibitors in later-line cholangiocarcinoma?
3. How do Orange Book listed patents and method-of-use claims influence generic switching after pemigatinib exclusivity ends?
4. What payer controls most strongly impact pemigatinib net price and persistence, prior authorization vs step therapy?
5. How do toxicity-management programs change real-world persistence for oral FGFR inhibitors like pemigatinib?

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References

1. FDA. Drugs@FDA: Pemazyre (pemigatinib) label and regulatory information. US Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Pemazyre, pemigatinib). US Food and Drug Administration.
3. FDA. Guidance for Industry: Paragraph IV notice and Orange Book patent listings (as applicable to branded drug exclusivity framework). US Food and Drug Administration.

DrugChatter Q&A for PEMAZYRE

Can pemazyre be used for bile duct cancer?