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BALVERSA Drug Profile

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Which patents cover Balversa, and what generic alternatives are available?

Balversa is a drug marketed by Janssen Biotech and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-seven patent family members in thirty-seven countries.

The generic ingredient in BALVERSA is erdafitinib. One supplier is listed for this compound. Additional details are available on the erdafitinib profile page.

Summary for BALVERSA

International Patents:	77
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Drug Prices:	Drug price information for BALVERSA
DailyMed Link:	BALVERSA at DailyMed

Generic Entry Opportunity Date for BALVERSA

NDA:

212018

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.

US Patents and Regulatory Information for BALVERSA

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

International Patents for BALVERSA

Country	Patent Number	Estimated Expiration
Montenegro	01825
China	102858765
Denmark	3178818
Croatia	P20182073
Canada	2796204