Erdafitinib - Generic Drug Details

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

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

Erdafitinib has one hundred and seventy-one patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for erdafitinib

International Patents:	171
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	26
Patent Applications:	598
What excipients (inactive ingredients) are in erdafitinib?	erdafitinib excipients list
DailyMed Link:	erdafitinib at DailyMed

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

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

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	212018-002	Apr 12, 2019		RX	Yes	No	⤷ 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	212018-003	Apr 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		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

International Patents for erdafitinib

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Country	Patent Number	Title	Estimated Expiration
Slovenia	3122742		⤷ Sign Up
Denmark	3256109		⤷ Sign Up
Morocco	41496	COMPOSITIONS PHARMACEUTIQUES COMPRENANT LA N-(3,5-DIMÉTHOXYPHÉNYL)-N'-(1-MÉTHYLÉTHYL)-N-[3-(1-MÉTHYL-1H-PYRAZOL-4-YL)QUINOXALIN-6-YL]ÉTHANE-1,2-DIAMINE	⤷ Sign Up
European Patent Office	3949954	COMPOSITIONS PHARMACEUTIQUES COMPRENANT N-(3,5-DIMETHOXYPHENYL)-N'-(1-METHYLETHYL)-N-[3-(1-METHYL-1H-PYRAZOL-4-YL)QUINOXALIN-6-YL]ETHANE-1,2-DIAMINE (PHARMACEUTICAL COMPOSITIONS COMPRISING N-(3,5-DIMETHOXYPHENYL)-N'-(1-METHYLETHYL)-N-[3-(1-METHYL-1H-PYRAZOL-4-YL)QUINOXALIN-6-YL]ETHANE-1,2-DIAMINE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.