ERDAFITINIB - Generic Drug Details

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What are the generic drug sources for erdafitinib and what is the scope of patent protection?

Erdafitinib is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Erdafitinib has two hundred and eighty-three patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for ERDAFITINIB

International Patents:	283
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	27
Patent Applications:	672
What excipients (inactive ingredients) are in ERDAFITINIB?	ERDAFITINIB excipients list
DailyMed Link:	ERDAFITINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERDAFITINIB

Generic Entry Date for ERDAFITINIB^: ⤷ 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 ERDAFITINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 2
M.D. Anderson Cancer Center	Phase 2
University of Washington	Phase 2

See all ERDAFITINIB clinical trials

Pharmacology for ERDAFITINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Fibroblast Growth Factor Receptor Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ERDAFITINIB

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 ERDAFITINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALVERSA	Tablets	erdafitinib	3 mg, 4 mg and 5 mg	212018	1	2023-04-12

US Patents and Regulatory Information for ERDAFITINIB

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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
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ERDAFITINIB

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Country	Patent Number	Title	Estimated Expiration
South Korea	101933843		⤷ Sign Up
New Zealand	602726	Pyrazolyl quinoxaline kinase inhibitors	⤷ Sign Up
Denmark	3198033		⤷ Sign Up
Hungary	E041738		⤷ Sign Up
Israel	251264	שימוש בפנלים של גן מוטנט fgfr בזיהוי חולי סרטן שיגיבו לטיפול עם מעכב fgfr (Use of fgfr mutant gene panels in identifying cancer patients that will be responsive to treatment with an fgfr inhibitor)	⤷ Sign Up
Eurasian Patent Organization	201500278	ПИРАЗОЛИЛХИНАЗОЛИНОВЫЕ ИНГИБИТОРЫ КИНАЗЫ	⤷ Sign Up
Spain	2899937		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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