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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-eight 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 January 30, 2035. 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:	168
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	7
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 nine US patents and four 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
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	213736-002	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	213736-003	Apr 17, 2020		RX	Yes	Yes
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	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

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

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 PEMAZYRE around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	3495367
Slovenia	2861595
South Korea	20150036044
Japan	6711946
Denmark	3176170
Canada	2876689	COMPOSES TRICYCLIQUES SUBSTITUES UTILISES COMME INHIBITEURS DE FGFR (SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS)
Taiwan	I706953

Supplementary Protection Certificates for PEMAZYRE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861595	2021C/536	Belgium		PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595	301131	Netherlands		PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1535 20210329
2861595	C202130046	Spain		PRODUCT NAME: PEMIGATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1535; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU//1/21/1535; DATE OF FIRST AUTHORISATION IN EEA: 20210326
2861595	LUC00222	Luxembourg		PRODUCT NAME: PEMIGATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595	CR 2021 00033	Denmark		PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1535 20210329
2861595	PA2021519,C2861595	Lithuania		PRODUCT NAME: PEMIGATINIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1535 20210326
2861595	35/2021	Austria		PRODUCT NAME: PEMIGATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1535 (MITTEILUNG) 20210329

Market Dynamics and Financial Trajectory for PEMAZYRE

Last updated: July 27, 2025

Introduction

PEMAZYRE (pemigatinib) has established itself as a pivotal drug within the oncology landscape, particularly targeting rare malignancies characterized by specific genetic mutations. Originally developed by INVICTUS Therapeutics and subsequently acquired by Janssen Pharmaceuticals, this oral kinase inhibitor exemplifies precision medicine’s rise and plays a strategic role in oncology R&D and commercialization. Its market dynamics and financial trajectory offer critical insights into niche-focused targeted therapies, competitive positioning, and the broader implications in the evolving landscape of cancer treatment.

Market Landscape and Therapeutic Indications

PEMAZYRE's primary indication is for treating cholangiocarcinoma, a rare bile duct cancer, in patients with fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements. The FDA approved PEMAZYRE in April 2020 under accelerated approval, marking a significant milestone, as it became one of the first targeted therapies approved specifically for FGFR2-driven cholangiocarcinoma [1].

Beyond cholangiocarcinoma, ongoing clinical trials evaluate PEMAZYRE's efficacy in other FGFR-altered cancers, including bladder cancer, gastric cancer, and multiple myeloma, potentially broadening its therapeutic scope. This targeted approach aligns with the increasing shift towards molecularly driven oncology, emphasizing biomarker-based treatments.

Market Dynamics

1. Unmet Medical Need and Market Entry

The rarity of FGFR2-positive cholangiocarcinoma constrains the overall market size, but the high unmet needs within this narrow segment bolster the drug's value proposition. Limited effective treatments previously led to poor prognosis, creating compelling demand for targeted options.

PEMAZYRE's accelerated approval facilitated rapid access, but subsequent full approvals and label expansions are necessary for sustained market penetration. Its designation as a first-in-class FGFR inhibitor for this indication renders it a pioneering asset, giving it a competitive advantage as the specific biomarker-driven therapy.

2. Competitive Landscape

Although PEMAZYRE is currently a leader in FGFR-targeted cholangiocarcinoma therapy, competition is emerging:

• Boehringer Ingelheim's Infigratinib: An FGFR inhibitor that presented early clinical data but has faced challenges securing approval for cholangiocarcinoma.
• Fibrogen's Futibatinib: An irreversible FGFR inhibitor showing promising efficacy.
• Other pipeline agents: New FGFR inhibitors in clinical trials could threaten PEMAZYRE's market share if approved with superior efficacy or safety profile.

The competitive dynamics revolve around efficacy, safety, biomarker validation, and regulatory approvals, with the FDA’s stance and payer coverage impacting uptake.

3. Regulatory and Reimbursement Factors

Post-accelerated approval, full FDA approval and coverage decisions are vital. Reimbursement policies in key markets (U.S., Europe, Asia) influence market access and patient adoption. Payers are scrutinizing cost-effectiveness, especially given the high costs associated with targeted therapies in rare cancers.

The drug's orphan drug status and fast-track designations facilitate expedited reimbursement pathways, but market access remains complex, sculpted by the drug's performance in post-approval trials and comparative effectiveness data.

4. Market Penetration and Adoption

During the initial launch, adoption faced challenges such as limited diagnostic testing infrastructure for FGFR mutations and clinician familiarity. However, increasing awareness, improved diagnostic testing capabilities, and positive clinical data bolster adoption. The integration of companion diagnostics into clinical workflows is critical for maximizing PEMAZYRE’s market penetration.

5. Market Size and Revenue Potential

The estimated initial market size in cholangiocarcinoma is modest, with ~7,000 cases diagnosed annually in the U.S., of which approximately 15-20% harbor FGFR2 alterations [2]. This yields an addressable patient base of roughly 1,000-1,400 annually.

Given the pricing model (approximate list price over $15,000 per month), total potential revenue in the primary indication could approach several hundred million dollars annually, assuming near-maximal penetration. Expansion into additional indications and indications will enhance revenue opportunities.

Financial Trajectory and Growth Drivers

1. Revenue Generation Timeline

2020-2022: Rapid initial sales following FDA approval, driven by early adopters and high unmet need. However, sales volumes were constrained by diagnostic testing gaps.

2023-2025: Anticipated growth due to increased recognition, expanded clinical indications, and improved diagnostic infrastructure. Regulatory approvals for broader indications, such as other FGFR-driven tumors, are expected to catalyze revenue growth.

Post-2025: Long-term revenue depends on competitive landscape evolution, reimbursement policies, and whether PEMAZYRE can secure additional label expansions or develop combination therapies.

2. Impact of Clinical Pipeline and Trials

Ongoing trials assessing PEMAZYRE’s efficacy in other FGFR-altered cancers could impact valuation positively if successful. Also, combination therapy trials with immunotherapies could unlock higher value, capitalize on synergistic effects, and expand indications.

3. Cost and Pricing Strategy

Pricing strategies, including potential discounts, rebates, and value-based negotiations, influence net revenue. The high cost of targeted therapies necessitates demonstrable clinical benefit, thus emphasizing positive trial outcomes.

4. External Challenges and Risks

• Regulatory delays: Any setbacks in approvals or label expansions.
• Biomarker testing limitations: Access and reimbursement for diagnostic tests.
• Emerging competition: Superior emerging therapies could diminish PEMAZYRE's market share.
• Pricing pressures: Payer pushback on high-cost targeted therapies.

Strategic Outlook and Future Trajectory

PEMAZYRE's future hinges on demonstrating sustained clinical benefit across various FGFR-altered tumor types and securing broader regulatory and reimbursement approvals. An emphasis on companion diagnostics will be vital for maximizing patient identification and treatment efficacy.

The strategic push into combination regimens and leveraging disease-awareness campaigns will underpin its growth. Strategic partnerships for diagnostics and expanding clinical trial programs are likely to sustain its market position.

Key Takeaways

• Niche Market Leadership: PEMAZYRE is a first-in-class FGFR inhibitor with a targeted approach in cholangiocarcinoma, driven by strong unmet medical needs.
• Growth Opportunities: Expanded indications, ongoing clinical trials, and combination therapies offer significant upside potential.
• Market Challenges: Competition, diagnostic test access, and pricing negotiations could temper growth.
• Revenue Potential: Estimated peak revenues in the hundreds of millions annually, contingent on broader approval and market access.
• Strategic Importance: PEMAZYRE exemplifies the shift towards precision medicine, emphasizing biomarker-driven therapy development and commercialization.

FAQs

1. What is the current market size for PEMAZYRE in its primary indication?
The U.S. cholangiocarcinoma market with FGFR2 alterations involves approximately 1,000–1,400 patients annually, representing a niche but strategically valuable segment.

2. How does PEMAZYRE compare to its competitors?
PEMAZYRE benefits from being first-in-class with accelerated FDA approval. However, competitors like futibatinib and infigratinib are progressing in clinical development, potentially challenging PEMAZYRE's market dominance with superior efficacy or safety profiles.

3. What factors will influence PEMAZYRE's long-term financial success?
Progress in label expansions, regulatory approvals, clinical trial outcomes, diagnostic testing infrastructure, payer coverage, and competition will shape its long-term financial trajectory.

4. How significant is the role of diagnostic testing in PEMAZYRE’s market adoption?
Crucial; precise molecular diagnostics identify eligible patients. Enhanced testing infrastructure will directly impact the drug’s utilization rates.

5. What strategic moves should stakeholders prioritize for maximizing PEMAZYRE’s value?
Focus on expanding clinical indications, securing regulatory approvals, investing in diagnostic partnerships, and advancing combination therapies to broaden its therapeutic footprint.

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References

[1] U.S. Food and Drug Administration. (2020). FDA grants accelerated approval to pemigatinib for cholangiocarcinoma.
[2] American Cancer Society. (2021). Cholangiocarcinoma statistics and epidemiology.