PEMIGATINIB - Generic Drug Details

What are the generic 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-nine patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for PEMIGATINIB

International Patents:	169
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	213736-003	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	213736-003	Apr 17, 2020		RX	Yes	Yes
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			Y	Y
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No

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
Netherlands	301131
Montenegro	02651	SUBSTITUISANA TRICIKLIČNA JEDINJENJA KAO INHIBITORI FGFR (SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS)
South Korea	20220080213	FGFR 억제제로서 치환된 트리사이클릭 화합물 (FGFR SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS)
Ukraine	117347
Croatia	P20201966
China	104507943
Lithuania	3495367

Supplementary Protection Certificates for PEMIGATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861595	202140025	Slovenia		PRODUCT NAME: PEMIGATINIB OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: EU/1/21/1535; DATE OF NATIONAL AUTHORISATION: 20210326; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2861595	132021000000140	Italy		PRODUCT NAME: PEMIGATINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(PEMAZYRE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1535, 20210329
2861595	PA2021519	Lithuania		PRODUCT NAME: PEMIGATINIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1535 20210326
2861595	CR 2021 00033	Denmark		PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. 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	21C1041	France		PRODUCT NAME: PEMIGATINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/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

Market Dynamics and Financial Trajectory for Pemigatinib

Last updated: February 23, 2026

What is Pemigatinib?

Pemigatinib is an oral selective inhibitor of fibroblast growth factor receptor (FGFR) 1, 2, and 3. It received FDA approval in April 2020 for adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. Its clinical development extends into other FGFR-driven malignancies.

Competitive Landscape and Market Drivers

Regulatory Milestones

• FDA Approval: April 2020 for cholangiocarcinoma [1].
• EMA Approval: February 2021 for similar indications.
• Other Approvals: Several countries including Japan, South Korea, and Canada have granted or are reviewing approvals.

Existing Therapies and Differentiators

• Comparable Drugs: Erdafitinib (FDA approved for FGFR-mutated bladder cancer) and infigratinib (phase 3 trials for cholangiocarcinoma).
• Unique Features: Selectivity for FGFR 1-3 reduces off-target effects, potentially increasing tolerability.

Market Size and Patient Population

• Cholangiocarcinoma: Incidence ranges from 1-2 cases per 100,000 annually in the US, with an estimated 4,800 cases in 2022 [2].
• FGFR2 Fusions: Present in 10-15% of intrahepatic cholangiocarcinoma patients.
• Other Indications: Potential for expansion into urothelial carcinoma, hepatocellular carcinoma, and other FGFR-driven cancers.

Market Penetration Factors

• Biomarker Testing: FGFR2 fusion testing is critical. Only a subset of patients qualify, limiting immediate market size.
• Pricing and Reimbursement: Initial treatment costs range from $10,000 to $15,000 per month. Reimbursement strategies vary across regions.
• Clinical Evidence: Demonstration of response rates (e.g., 35-41%) and durability influences prescribing practices.

Financial Trajectory

Revenue Projections

• 2022: Estimated global sales of Pemigatinib range between $50 million and $75 million.
• 2025: Forecasted to grow to approximately $300 million, driven by increased adoption and expanded indications [3].

Growth Drivers

• Expanded Indications: Clinical trials are exploring efficacy in additional FGFR-driven tumors.
• Geographic Expansion: Approvals in Asia, Europe, and Latin America will broaden patient access.
• Pipeline Developments: Amgen's ongoing phase 2 studies may support label extensions.

Barriers to Growth

• Competitive Landscape: Erdafitinib and Infigratinib pose direct competition; efficacy and safety profiles determine market share.
• Biomarker Testing Limitations: Not all patients are tested or have FGF pathway alterations.
• Pricing Pressures: Payers may push for discounts, impacting profit margins.

Strategic Considerations

• Partnerships and Licensing: Collaborations with regional companies to accelerate market entry.
• Real-World Evidence: Collection of safety and efficacy data to support expanded use.
• Pricing Strategies: Adoption of value-based pricing models to optimize reimbursement.

Summary of Market Outlook

Pemigatinib's utilization remains heavily dependent on biomarker-driven patient selection. The current global market is modest but expected to compound rapidly as approvals expand, indications grow, and clinical evidence accrues. Although competition is intense, Pemigatinib’s specificity and early market entry offer significant growth opportunities. The financial trajectory suggests a compound annual growth rate of nearly 70% from 2022 to 2025, reaching over $300 million in sales.

Key Takeaways

• Pemigatinib has FDA approval for FGFR2 fusion-positive cholangiocarcinoma.
• Market size is limited initially to eligible patients, approximately 5,000 in the US annually.
• Growth depends on expanded indications, geographic scale-up, and improved biomarker testing.
• Competition from other FGFR inhibitors influences pricing and market share.
• Future revenue streams hinge on clinical trial results, regulatory decisions, and payer acceptance.

FAQs

1. What are the primary indications for Pemigatinib?
Currently, it is approved for locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

2. When is Pemigatinib expected to reach peak sales?
Estimates suggest peak sales could surpass $500 million globally by 2027, contingent on approval of additional indications and market expansion.

3. How significant is biomarker testing for Pemigatinib’s market?
Critical; only patients with FGFR2 fusions qualify, and widespread testing is necessary for optimal patient selection.

4. How does Pemigatinib compare to competitors?
It offers higher selectivity and a favorable safety profile compared to less selective FGFR inhibitors, but faces competition mainly from erdafitinib and infigratinib.

5. What are the main risks affecting Pemigatinib’s financial outlook?
Potential delays in regulatory approvals, safety concerns, payer coverage limitations, and emerging competition.

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References

[1] U.S. Food and Drug Administration. (2020). FDA approves Pemigatinib for cholangiocarcinoma. https://www.fda.gov

[2] Siegel, R. L., Miller, K. D., & Jemal, A. (2022). Cancer statistics, 2022. CA: A Cancer Journal for Clinicians, 72(1), 7-33.

[3] MarketWatch. (2022). Pemigatinib market forecast 2022-2027. https://www.marketwatch.com