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Last Updated: June 27, 2022

BALVERSA Drug Patent Profile


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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

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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
Drug patent expirations by year for BALVERSA
Drug Prices for BALVERSA

See drug prices for BALVERSA

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Janssen Research & Development, LLCPhase 2

See all BALVERSA clinical trials

US Patents and Regulatory Information for BALVERSA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BALVERSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Pyrazolyl quinoxaline kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrazolyl quinoxaline kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BALVERSA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 Apr 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 Apr 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 16218000
Estimated Expiration: See Plans and Pricing

Patent: 20250263
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017017009
Estimated Expiration: See Plans and Pricing

Canada

Patent: 76356
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17002022
Estimated Expiration: See Plans and Pricing

China

Patent: 7427511
Estimated Expiration: See Plans and Pricing

Patent: 3209102
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17008862
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 170411
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0211244
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 56109
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9646
Estimated Expiration: See Plans and Pricing

Patent: 1791798
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 56109
Estimated Expiration: See Plans and Pricing

Patent: 49954
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 56761
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3700
Estimated Expiration: See Plans and Pricing

Patent: 1024
Estimated Expiration: See Plans and Pricing

Japan

Patent: 96588
Estimated Expiration: See Plans and Pricing

Patent: 18505193
Estimated Expiration: See Plans and Pricing

Patent: 21038241
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 0200201
Estimated Expiration: See Plans and Pricing

Patent: 95
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 56109
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17010287
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 496
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1700101
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017501421
Estimated Expiration: See Plans and Pricing

Poland

Patent: 56109
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 56109
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 221
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202000734Y
Estimated Expiration: See Plans and Pricing

Patent: 201706472R
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 56109
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170110145
Estimated Expiration: See Plans and Pricing

Spain

Patent: 83829
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 19960
Estimated Expiration: See Plans and Pricing

Patent: 1630608
Estimated Expiration: See Plans and Pricing

Patent: 2123939
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3767
Estimated Expiration: See Plans and Pricing

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
AstraZeneca
Merck
McKesson
Colorcon

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.