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Last Updated: March 28, 2024

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BALVERSA Drug Patent 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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-eight patent family members in forty-three 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 was eligible for patent challenges on April 12, 2023.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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  Try a Trial

Summary for BALVERSA
International Patents:198
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 8
Patent Applications: 249
Drug Prices: Drug price information for BALVERSA
What excipients (inactive ingredients) are in BALVERSA?BALVERSA excipients list
DailyMed Link:BALVERSA at DailyMed
Drug patent expirations by year for BALVERSA
Drug Prices for BALVERSA

See drug prices for BALVERSA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BALVERSA
Generic Entry Date for BALVERSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
National Cancer Institute (NCI)Phase 1
M.D. Anderson Cancer CenterPhase 2
University of WashingtonPhase 2

See all BALVERSA clinical trials

Paragraph IV (Patent) Challenges for BALVERSA
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 BALVERSA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BALVERSA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-di- amine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY

Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-di- amine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY

Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-di- amine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY

Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-di- amine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY

Cancer treatment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS, AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY

Pyrazolyl quinoxaline kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pyrazolyl quinoxaline kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY

Quinoxaline derivatives useful as FGFR kinase modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting BALVERSA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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

Patent: 3645
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 16218000
Estimated Expiration: ⤷  Try a Trial

Patent: 20250263
Estimated Expiration: ⤷  Try a Trial

Patent: 22291429
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017017009
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 76356
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 17002022
Estimated Expiration: ⤷  Try a Trial

China

Patent: 7427511
Estimated Expiration: ⤷  Try a Trial

Patent: 8290184
Estimated Expiration: ⤷  Try a Trial

Patent: 3209102
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 17008862
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 170411
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0211244
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 24432
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 56109
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9646
Estimated Expiration: ⤷  Try a Trial

Patent: 1791798
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 56109
Estimated Expiration: ⤷  Try a Trial

Patent: 47143
Estimated Expiration: ⤷  Try a Trial

Patent: 49954
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 56761
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3700
Estimated Expiration: ⤷  Try a Trial

Patent: 1024
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 96588
Estimated Expiration: ⤷  Try a Trial

Patent: 18505193
Estimated Expiration: ⤷  Try a Trial

Patent: 21038241
Estimated Expiration: ⤷  Try a Trial

Patent: 23011758
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 0200201
Estimated Expiration: ⤷  Try a Trial

Patent: 95
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 56109
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6599
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 17010287
Estimated Expiration: ⤷  Try a Trial

Patent: 21004110
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 496
Estimated Expiration: ⤷  Try a Trial

Patent: 571
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1700101
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 017501421
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 56109
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 56109
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 221
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202000734Y
Estimated Expiration: ⤷  Try a Trial

Patent: 201706472R
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 56109
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 170110145
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 83829
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 19960
Estimated Expiration: ⤷  Try a Trial

Patent: 1630608
Estimated Expiration: ⤷  Try a Trial

Patent: 2123939
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 3767
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 42142
Estimated Expiration: ⤷  Try a Trial

Patent: 1515912
Estimated Expiration: ⤷  Try a Trial

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
Slovenia 3122742 ⤷  Try a Trial
Singapore 10201708578Q PYRAZOLYL QUINOXALINE KINASE INHIBITORS ⤷  Try a Trial
Israel 281024 תכשירים רוקחיים המכילים 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) ⤷  Try a Trial
Jordan 3366 مثبطات بيرازوليل كوينوكزالين كاينيز (Pyrazolyl Quinoxaline Kinase Inhibitors) ⤷  Try a Trial
Mexico 2022007955 REGIMENES DE DOSIFICACION DE ERDAFITINIB. (CANCER TREATMENT.) ⤷  Try a Trial
Portugal 3590934 ⤷  Try a Trial
South Africa 201706763 PYRAZOLYL QUINOXALINE KINASE INHIBITORS ⤷  Try a Trial
>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.