BALVERSA Drug Patent Profile

Which patents cover Balversa, and when can generic versions of Balversa launch?

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

This drug has one hundred and sixty-six patent family members in forty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Balversa

Balversa will be eligible for patent challenges on April 12, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 9, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BALVERSA

International Patents:	166
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	6
Patent Applications:	193
Drug Prices:	Drug price information for BALVERSA
What excipients (inactive ingredients) are in BALVERSA?	BALVERSA excipients list
DailyMed Link:	BALVERSA at DailyMed

See drug prices for BALVERSA

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for BALVERSA

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 2
Janssen Research & Development, LLC	Phase 2

See all BALVERSA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BALVERSA

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 BALVERSA

BALVERSA is protected by eight US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BALVERSA

FDA Regulatory Exclusivity protecting 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
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	212018-003	Apr 12, 2019		RX	Yes	Yes			Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No			Y	Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes

International Patents for BALVERSA

When does loss-of-exclusivity occur for BALVERSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Morocco

Nicaragua

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BALVERSA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016218000	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
Spain	2899937
Denmark	3178818
Denmark	3122742
Serbia	62570	INHIBITORI KINAZE PIRAZOLIL HINOKSALINA (PYRAZOLYL QUINOXALINE KINASE INHIBITORS)
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.)
New Zealand	724907	Quinoxaline derivatives useful as fgfr kinase modulators