Erdafitinib - Generic Drug Details

What are the generic drug 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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for erdafitinib

International Patents:	181
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
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

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

US Patents and Regulatory Information for erdafitinib

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

International Patents for erdafitinib

Country	Patent Number	Title	Estimated Expiration
Poland	3122742
Singapore	10202105110V	CANCER TREATMENT
Slovenia	2563775
Poland	2563775
Mexico	2017010287	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN N-(3,5-DIMETOXIFENIL)-N '-(1-METILETIL)-N-[3-(1-METIL-1H-PIRAZOL-4-IL)QUINOXALIN-6-IL]ETA NO-1,2-DIAMINA. (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.)
Eurasian Patent Organization	201500278	ПИРАЗОЛИЛХИНАЗОЛИНОВЫЕ ИНГИБИТОРЫ КИНАЗЫ
Portugal	2563775