Pemigatinib - Generic Drug Details

What are the generic sources for pemigatinib and what is the scope of freedom to operate?

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

Constraining patent/regulatory exclusivity:

9,611,267

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	213736-001	Apr 17, 2020		RX	Yes	No	9,611,267		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
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No	11,628,162
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes	10,131,667
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No	11,466,004
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
Slovenia	3495367
Malaysia	171375	SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS
Australia	2020270520	SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS
Australia	2019200066	SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS
Spain	2704744
Ecuador	SP15001225	COMPUESTOS TRICÍCLICOS SUSTITUIDOS COMO INHIBIDORES DEL RECEPTOR DEL FACTOR DE CRECIMIENTO DE FIBROBLASTOS
Israel	256976	המרת תרכובות טריסייקליות כמעכבות fgfr (Substituted tricyclic compounds as fgfr inhibitors)

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	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	C02861595/01	Switzerland		PRODUCT NAME: PEMIGATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68143 13.07.2021
2861595	2021C/536	Belgium		PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595	21C1041	France		PRODUCT NAME: PEMIGATINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1535 20210329
2861595	122021000054	Germany		PRODUCT NAME: PEMIGATINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1535 20210326
2861595	301131	Netherlands		PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1535 20210329