PEMIGATINIB - Generic Drug Details

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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

Generic Entry Date for PEMIGATINIB^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-002	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for PEMIGATINIB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for PEMIGATINIB

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Country	Patent Number	Title	Estimated Expiration
China	104507943	Substituted tricyclic compounds as FGFR inhibitors	⤷ Sign Up
Peru	20150684	COMPUESTOS TRICICLICOS SUSTITUIDOS COMO INHIBIDORES DEL RECEPTOR DEL FACTOR DE CRECIMIENTO DE FIBROBLASTOS (FGFR)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2019213544		⤷ Sign Up
South Korea	102406771		⤷ Sign Up
Mexico	2014015192	COMPUESTOS TRICICLICOS SUSTITUIDOS COMO INHIBIDORES DEL RECEPTOR DEL FACTOR DE CRECIMIENTO DE FIBROBLASTOS (FGFR). (SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS.)	⤷ Sign Up
European Patent Office	3495367	COMPOSÉS TRICYCLIQUES SUBSTITUÉS SERVANT D'INHIBITEURS DES FGFR (SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PEMIGATINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861595	C02861595/01	Switzerland	⤷ Sign Up	PRODUCT NAME: PEMIGATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68143 13.07.2021
2861595	PA2021519	Lithuania	⤷ Sign Up	PRODUCT NAME: PEMIGATINIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1535 20210326
2861595	132021000000140	Italy	⤷ Sign Up	PRODUCT NAME: PEMIGATINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(PEMAZYRE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1535, 20210329
2861595	122021000054	Germany	⤷ Sign Up	PRODUCT NAME: PEMIGATINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1535 20210326
2861595	CR 2021 00033	Denmark	⤷ Sign Up	PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1535 20210329
2861595	21C1041	France	⤷ Sign Up	PRODUCT NAME: PEMIGATINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1535 20210329
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.