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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 thirty-six patent family members in thirty-eight 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:	136
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	7
Patent Applications:	58
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

Constraining patent/regulatory exclusivity:

9,611,267

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
Incyte Biosciences International Sàrl	Phase 2
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	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.

This potential generic entry date is based on patent 9,611,267.

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	11,466,004
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No	10,131,667
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-002	Apr 17, 2020		RX	Yes	No	11,628,162
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

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/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 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
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 PEMAZYRE

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

PEMAZYRE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEMAZYRE

Introduction to PEMAZYRE

PEMAZYRE, also known as pemigatinib, is a selective fibroblast growth factor receptor (FGFR) inhibitor that has garnered significant attention in the pharmaceutical industry. Approved by the U.S. Food and Drug Administration (FDA) in 2020, it has been a game-changer in the treatment of specific types of cancer.

FDA Approval and Indications

PEMAZYRE was initially approved under the FDA's accelerated approval program for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement[1][3][4].

In 2022, it received a second indication as the first and only targeted treatment for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement, solidifying its position as a versatile FGFR inhibitor[4].

Clinical Efficacy

The clinical efficacy of PEMAZYRE is well-documented. In the Phase II trial (Study FIGHT-202), 38 out of 107 patients (36%) achieved partial or complete shrinkage of the tumor. Notably, 63% of these patients had a cancer shrinkage lasting 6 months or longer, and 18% had it lasting 12 months or longer[1][3].

Overall Response Rate and Duration of Response

• Overall Response Rate (ORR): 36% (95% CI: 27, 45)
• Complete Response: 2.8%
• Partial Response: 33%
• Median Duration of Response (DoR): 9.1 months (95% CI: 6.0, 14.5)
• Patients with DoR ≥ 6 months: 63%
• Patients with DoR ≥ 12 months: 18%[1].

Safety Profile

The safety data from the Phase II Study FIGHT-202 and integrated safety data from other clinical studies reveal a consistent safety profile for PEMAZYRE. However, the final product monograph includes safety data from the 146 patients in the FIGHT-202 trial[3].

Market Authorization and Regulatory Status

PEMAZYRE's market authorization is based on quality, non-clinical, and clinical data submitted to regulatory bodies. Health Canada's review concluded a favorable benefit-harm-uncertainty profile for the treatment of adults with specific FGFR2 rearrangements in cholangiocarcinoma[3].

Financial Performance

Revenue and Sales

PEMAZYRE has contributed significantly to Incyte's financial performance. For the third quarter of 2024, total net product and royalty revenues for PEMAZYRE were part of the overall revenue of $1,119,871, with PEMAZYRE-specific revenues showing a steady growth trajectory[2].

• Total Net Product Revenues: $20,661 for the third quarter of 2024, indicating a growth trend.
• Royalty Revenues: Included in the total royalty revenues, which were $156,879 for the quarter[2].

Quarterly and Annual Financials

Incyte's financial reports highlight the consistent contribution of PEMAZYRE to their revenue streams. Here are some key financial metrics:

• Total GAAP Revenues: $1,137,871 for the third quarter of 2024, up from $919,025 in the same quarter of the previous year[2].
• Non-GAAP Operating Income: $255,236 for the third quarter of 2024, reflecting the drug's positive impact on operational income[2].

Comparative Financials

Comparing the second quarter of 2024 to the same period in the previous year, Incyte's total GAAP revenues and non-GAAP operating income show a positive trend, with PEMAZYRE being a significant contributor to these figures[5].

Market Dynamics

Competitive Landscape

PEMAZYRE is the only FGFR inhibitor with multiple indications, making it a unique player in the market. Its approval for two distinct cancer types sets it apart from other treatments, providing a competitive edge in the oncology market[4].

Patient and Physician Adoption

The drug's efficacy and safety profile have led to its adoption by both patients and physicians. The accelerated approval and subsequent full approval based on ongoing clinical trials have enhanced its credibility and acceptance in the medical community.

Regulatory Environment

The regulatory environment has been favorable for PEMAZYRE, with approvals from key regulatory bodies like the FDA and Health Canada. This favorable regulatory landscape has facilitated its market entry and expansion.

Future Outlook

Ongoing Clinical Trials

The ongoing randomized Phase III Study INCB54828-302 is expected to provide further confirmation of PEMAZYRE's efficacy and safety. Positive outcomes from this study could lead to expanded indications and increased market share[3].

Market Expansion

Given its unique position in the market and the growing demand for targeted cancer therapies, PEMAZYRE is poised for continued growth. Expansion into new markets and potential new indications could further bolster its financial performance.

Key Takeaways

• Clinical Efficacy: PEMAZYRE has shown significant efficacy in treating cholangiocarcinoma and MLNs with FGFR rearrangements.
• Financial Performance: The drug has contributed substantially to Incyte's revenue and operating income.
• Market Dynamics: It holds a unique position in the market with multiple indications and a favorable regulatory environment.
• Future Outlook: Ongoing clinical trials and potential market expansion are expected to drive continued growth.

FAQs

Q: What is PEMAZYRE used for?

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

Q: How was PEMAZYRE approved?

PEMAZYRE was approved under the FDA's accelerated approval program in 2020 and received a second indication in 2022.

Q: What are the key efficacy metrics for PEMAZYRE?

The overall response rate (ORR) is 36%, with a median duration of response (DoR) of 9.1 months. 63% of patients had a cancer shrinkage lasting 6 months or longer, and 18% had it lasting 12 months or longer.

Q: What is the safety profile of PEMAZYRE?

The safety data from clinical trials reveal a consistent safety profile, although the final product monograph includes safety data from a specific subset of patients.

Q: How has PEMAZYRE impacted Incyte's financials?

PEMAZYRE has significantly contributed to Incyte's revenue and operating income, with steady growth in net product revenues and royalty revenues.

Sources

1. FDA: Drug Trials Snapshot: PEMAZYRE - FDA
2. Incyte: Incyte Reports 2024 Third Quarter Financial Results and Provides ...
3. Health Canada: Summary Basis of Decision for Pemazyre
4. Incyte: Incyte Announces FDA Approval of Pemazyre® (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
5. Incyte: Incyte Reports 2024 Second Quarter Financial Results and Provides Updates on Key Clinical Programs