Pemigatinib - Generic Drug Details

What are the generic drug sources for pemigatinib and what is the scope of patent protection?

Pemigatinib is the generic ingredient in one branded drug marketed by Incyte Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pemigatinib has one hundred and sixty-eight patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for pemigatinib

International Patents:	168
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	41
Patent Applications:	5,054
What excipients (inactive ingredients) are in pemigatinib?	pemigatinib excipients list
DailyMed Link:	pemigatinib at DailyMed

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

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 pemigatinib

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

Sponsor	Phase
Sameek Roychowdhury	PHASE2
University of Alabama at Birmingham	PHASE2
AstraZeneca	PHASE2

See all pemigatinib clinical trials

Pharmacology for pemigatinib

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

Anatomical Therapeutic Chemical (ATC) Classes for pemigatinib

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PEMIGATINIB

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 pemigatinib

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

EU/EMA Drug Approvals for pemigatinib

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 pemigatinib

Country	Patent Number	Title	Estimated Expiration
Slovenia	3495367
Slovenia	2861595
South Korea	20150036044
Japan	6711946

Supplementary Protection Certificates for pemigatinib

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

Market Dynamics and Financial Trajectory for Pemigatinib

Last updated: July 29, 2025

Introduction

Pemigatinib, marketed under brand names such as Pemazyre, is an oral FGFR (fibroblast growth factor receptor) inhibitor developed primarily for treating cholangiocarcinoma and other FGFR-driven cancers. Its regulatory approval and subsequent market adoption have positioned it as a cornerstone in targeted oncology therapy. This analysis explores the evolving market landscape, financial outlook, competitive positioning, and key factors influencing pemigatinib's commercial trajectory.

Regulatory Milestones and Market Entry

Pemigatinib received accelerated approval from the U.S. Food and Drug Administration (FDA) in April 2020 for treating cholangiocarcinoma with FGFR2 gene fusions or rearrangements, marking an early mover advantage in FGFR-targeted therapies. The approval was based on Phase II data demonstrating meaningful response rates in a subset of patients with advanced, unresectable cholangiocarcinoma. Subsequent approvals ensued in other regions, including the European Union.

Regulatory validation set the stage for rapid market penetration, especially considering its niche indication. The drug's initial label restriction to FGFR2 alterations has influenced prescribing practices and market scope, although ongoing clinical trials aim to expand its indications.

Market Dynamics

Demand Drivers

• Unmet Medical Need: Cholangiocarcinoma, a rare and aggressive biliary tract cancer, has limited therapeutic options, establishing pemigatinib as a crucial targeted therapy.
• Precision Oncology Paradigm: The shift toward molecular-guided treatments has increased demand for biomarker-driven drugs like pemigatinib.
• Growing Diagnostic Capabilities: Advances in genomic profiling enable precise identification of FGFR2 fusions, expanding the eligible patient population.
• Expanding Indications: Ongoing clinical trials targeting other FGFR-driven cancers (e.g., urothelial carcinoma, gastric cancers) may broaden market applicability.

Competitive Landscape

Pemigatinib faces competition from other FGFR inhibitors such as infigratinib (Incyte), futibatinib (jijiharaThera), and erdafitinib (for urothelial cancer). Strategic differentiation, including efficacy, safety profile, and regulatory approvals, influences market share.

Market Challenges

• Biomarker Testing: Reliance on precise molecular diagnostics can delay treatment initiation and limit patient identification.
• Resistance Development: Tumor adaptation may lead to resistance, necessitating combination strategies or next-generation inhibitors.
• Pricing and Reimbursement: As a targeted therapy for a rare indication, pricing strategies and payer approval impact market access and revenue.

Market Size and Revenue Potential

Based on global cholangiocarcinoma incidence (~8,000-10,000 cases annually in the U.S., with higher numbers in regions like Asia and Europe), and prevalence estimates of FGFR2 alterations (~10-15% in cholangiocarcinoma), the immediate addressable market is modest but growing.

Projections suggest that pemigatinib could generate annual revenues in the hundreds of millions, with potential for expansion as indications broaden and diagnostic testing becomes more widespread.

Financial Trajectory

Revenue Trends

Initial sales post-approval have shown promising growth, driven by early adoption in major markets. Licensing deals, such as the collaboration between INVICTUS and distributors, continue to expand commercial reach.

Pricing Strategy

Pricing in the U.S. reportedly ranges between $14,000-$15,000 per month, aligning with other targeted oncology therapies. Cost considerations, especially amidst value-based healthcare models, influence payer negotiations and patient access.

Research & Development Investment

Continued investment in clinical trials, including Phase III studies for alternative indications, shapes future revenue streams. These R&D activities aim to solidify pemigatinib's position and foster lifecycle management through label expansions.

Regulatory and Market Risks

Potential label restrictions, emerging competition, and the development of resistance mechanisms pose risks to revenue stability. Additionally, reimbursement hurdles in certain payers and regions could impact sales.

Long-term Outlook

With a projected pipeline expansion and possible indication broadening, pemigatinib's financial trajectory appears secure for the medium term. Strategic partnerships and licensing agreements are likely to enhance revenue streams further.

Market Expansion Opportunities

• New Indications: Trials targeting bladder, gastric, and urothelial carcinomas may extend market scope.
• Biomarker Programs: Development of more comprehensive diagnostics will facilitate broader patient identification.
• Combination Therapies: Synergistic regimens with immunotherapies could improve outcomes, potentially elevating pemigatinib’s utilization.

Conclusion

Pemigatinib’s market dynamics are characterized by its position as a pioneer in FGFR-targeted cholangiocarcinoma therapy, with a promising yet evolving landscape. Its financial trajectory hinges on successful indication expansion, competitive positioning, and the integration of molecular diagnostics into clinical practice. Continuous innovation, strategic collaborations, and adaptive regulatory strategies will be pivotal to unlocking its full market potential.

---

Key Takeaways

• Pemigatinib’s early approval and targeted mechanism have established it as a key player in niche oncology markets.
• Growth is driven by increasing molecular diagnostics, expanding indications, and unmet medical needs.
• Competition from other FGFR inhibitors necessitates ongoing differentiation through efficacy and safety.
• Revenue forecasts anticipate steady growth, contingent on pipeline development, regulatory support, and market access.
• Strategic investments in clinical trials and diagnostics will be critical in maximizing pemigatinib’s financial impact.

---

FAQs

1. What are the primary approved indications for pemigatinib?
Pemigatinib is approved for cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements, primarily in adults with unresectable or metastatic disease.

2. How does pemigatinib compare to other FGFR inhibitors?
While all FGFR inhibitors target similar pathways, variations in efficacy, safety profiles, resistance mechanisms, and regulatory approvals influence their competitive positioning. Pemigatinib’s early approval and specific indication set it apart initially.

3. What are the barriers to pemigatinib’s broader market adoption?
Key barriers include reliance on precise biomarker testing, resistance development, competitive drugs, and regulatory restrictions that limit its use to FGFR2-positive cholangiocarcinoma.

4. Is pemigatinib being tested for other cancers?
Yes, ongoing clinical trials are exploring pemigatinib’s efficacy in other FGFR-driven malignancies such as urothelial carcinoma, gastric cancer, and bladder cancer.

5. What is the projected revenue outlook for pemigatinib?
Initial revenues are expected in the hundreds of millions annually, with potential for growth as indication expansions and diagnostics improve. Long-term success relies on ongoing clinical development and market penetration strategies.

---

Sources

1. FDA approval documents and label information.
2. Company press releases and financial disclosures.
3. Market research reports on FGFR inhibitors and cholangiocarcinoma treatments.
4. Clinical trial registries (ClinicalTrials.gov).
5. Industry analysis articles from Bloomberg and similar outlets.