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 thirty-six patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for PEMIGATINIB

International Patents:	136
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	32
Patent Applications:	184
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
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	Phase 2
Tianjin Medical University Cancer Institute and Hospital	Phase 2
Zhejiang Cancer Hospital	Phase 2

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	213736-002	Apr 17, 2020		RX	Yes	No
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

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/005266 Pemazyre 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
Lithuania	C2861595
Spain	2832497
Croatia	P20170430
Ecuador	SP15001225	COMPUESTOS TRICÍCLICOS SUSTITUIDOS COMO INHIBIDORES DEL RECEPTOR DEL FACTOR DE CRECIMIENTO DE FIBROBLASTOS
Israel	236078	המרת תרכובות טריסייקליות כמעכבות fgfr (Substituted tricyclic compounds as fgfr inhibitors)
World Intellectual Property Organization (WIPO)	2020185532

Supplementary Protection Certificates for PEMIGATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C20210023 00404	Estonia		PRODUCT NAME: PEMIGATINIIB;REG NO/DATE: EU/1/21/1535 29.03.2021
2861595	CR 2021 00033	Denmark		PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. 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	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

PEMIGATINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pemigatinib

Introduction to Pemigatinib

Pemigatinib, marketed as Pemazyre, is a selective inhibitor of fibroblast growth factor receptors (FGFRs), particularly FGFR1, 2, and 3. It has been approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and more recently for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement[2][3].

Market Size and Growth

The global pemigatinib market is experiencing significant growth, driven by advancements in precision medicine and targeted therapies for cancer treatment. As of 2024, the market size was valued at USD 95.11 million and is projected to reach USD 258.76 million by 2032, with a Compound Annual Growth Rate (CAGR) of 9.83% during the forecast period of 2025 to 2032[1].

Key Drivers of Market Growth

Growing Focus on Precision Medicine

The increasing incidence of cancer, particularly cholangiocarcinoma, is a major driver of the pemigatinib market. According to the World Health Organization (WHO), the number of new cancer cases is expected to rise from 18.1 million in 2018 to 29.4 million by 2040, which will boost the demand for targeted cancer therapies like pemigatinib[1].

Advancements in Companion Diagnostics

Technological advancements such as next-generation sequencing (NGS) have facilitated patient selection for pemigatinib therapy by identifying FGFR genetic alterations. This personalized approach enhances treatment outcomes and fosters research into combination therapies, improving efficacy and addressing resistance mechanisms[1].

Expanding Indications

Pemigatinib has received FDA approval for two indications: cholangiocarcinoma with FGFR2 fusion or rearrangement and MLNs with FGFR1 rearrangement. Ongoing clinical trials are exploring its effectiveness in various solid tumors, which is expected to further expand its market[2].

Regulatory Approvals and Market Access

Regulatory approvals in multiple regions have widened market access for pemigatinib. For instance, it has conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA)[3].

Geographical Market Dynamics

North America

North America is expected to dominate the pemigatinib market due to the presence of major key players, a well-developed healthcare sector, and advancements in treatment options. The robust infrastructure and increasing investment in cancer therapies in this region contribute to its leading position[1].

Asia-Pacific

The Asia-Pacific region is anticipated to show significant growth in the pemigatinib market. This is driven by increasing research and development activities, rising investments in the healthcare sector, and growing government support aimed at enhancing cancer treatment options and improving patient outcomes[1].

Financial Trajectory

Cost-Effectiveness and Pricing

The cost-effectiveness of pemigatinib is a critical factor in its financial trajectory. According to the Canadian Agency for Drugs and Technologies in Health (CADTH), the incremental cost-effectiveness ratio (ICER) for pemigatinib compared to active symptom control (ASC) and mFOLFOX plus ASC is high, requiring significant price reductions to be considered cost-effective. For instance, a price reduction of 95% to 100% would be needed for pemigatinib to achieve an ICER of $50,000 per quality-adjusted life-year (QALY) gained compared to mFOLFOX and ASC[4].

Market Segmentation and Distribution

The pemigatinib market is segmented by type (4.5 mg, 9 mg, and 13.5 mg), application (cholangiocarcinoma and others), dosage (tablet and others), route of administration (oral and other), end-users (clinic, hospital, and others), and distribution channel (hospital pharmacy, retail pharmacy, and online pharmacy). This segmentation helps in targeting specific patient populations and healthcare settings, optimizing market reach and revenue[1].

Revenue Projections

The annual revenue from pemigatinib is substantial, with the 28-day cycle cost estimated at $15,499, or $202,039 annually if patients remain on therapy for a full year. This revenue is expected to grow as the market expands and more patients are treated with pemigatinib[4].

Challenges and Opportunities

High Testing Costs

The high cost of testing to identify patients eligible for pemigatinib therapy is a significant challenge. It is estimated that testing costs around $38,000 to identify a single patient, which affects the overall cost-effectiveness of the treatment[4].

Emerging Markets

Countries such as India and Brazil are investing heavily in healthcare infrastructure and oncology treatments, presenting significant opportunities for pemigatinib. These emerging markets can provide a substantial growth avenue for the drug as healthcare systems prioritize advanced therapies[1].

Adverse Events and Safety Profile

Pemigatinib is associated with various adverse events, including hyperphosphatemia, increased AST and ALT, mucositis, and stomatitis. Managing these side effects is crucial for maintaining patient compliance and overall treatment outcomes[5].

Key Takeaways

• Growing Market: The global pemigatinib market is projected to grow from USD 95.11 million in 2024 to USD 258.76 million by 2032.
• Precision Medicine: The drug's efficacy in treating FGFR-related cancers is driven by advancements in precision medicine.
• Expanding Indications: Pemigatinib has multiple approved indications and is being explored for various solid tumors.
• Geographical Dynamics: North America and Asia-Pacific are key regions driving market growth.
• Cost-Effectiveness: High testing and treatment costs pose challenges to its cost-effectiveness.
• Emerging Markets: Investments in healthcare infrastructure in emerging economies offer significant growth opportunities.

Frequently Asked Questions (FAQs)

What is pemigatinib used for?

Pemigatinib is used for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement[2].

What are the common side effects of pemigatinib?

Common side effects include hyperphosphatemia, increased AST and ALT, mucositis, stomatitis, and other gastrointestinal and hematological adverse events[5].

How does pemigatinib work?

Pemigatinib works by inhibiting fibroblast growth factor receptors (FGFRs), specifically FGFR1, 2, and 3, which are involved in the growth and proliferation of cancer cells[3].

What is the projected market size of pemigatinib by 2032?

The global pemigatinib market is projected to reach USD 258.76 million by 2032, with a CAGR of 9.83% during the forecast period of 2025 to 2032[1].

Which regions are expected to dominate the pemigatinib market?

North America is expected to dominate the market due to its well-developed healthcare sector and advancements in treatment options, while the Asia-Pacific region is anticipated to show significant growth driven by increasing research and development activities[1].

Cited Sources:

1. Data Bridge Market Research: Global Pemigatinib Market – Global Size, Share, and Trends Analysis Report.
2. NCODA: Incyte Announces FDA Approval of Pemazyre® (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement.
3. Scottish Medicines Consortium: Pemigatinib 4.5mg, 9mg, and 13.5mg tablets (Pemazyre®).
4. NCBI: Pharmacoeconomic Review - Pemigatinib (Pemazyre).
5. e-CRT: Global Expanded Access Program for Pemigatinib in Patients with Cholangiocarcinoma.