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 two hundred and one 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
Summary for BALVERSA
| International Patents: | 201 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 52 |
| Clinical Trials: | 8 |
| Patent Applications: | 183 |
| Drug Prices: | Drug price information for BALVERSA |
| What excipients (inactive ingredients) are in BALVERSA? | BALVERSA excipients list |
| DailyMed Link: | BALVERSA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BALVERSA
*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 |
| University of Washington | Phase 2 |
Pharmacology for BALVERSA
Anatomical Therapeutic Chemical (ATC) Classes for BALVERSA
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 fifteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BALVERSA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Cancer treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Cancer treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Pyrazolyl quinoxaline kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyrazolyl quinoxaline kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Quinoxaline derivatives useful as FGFR kinase modulators
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting BALVERSA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (MUC)WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| 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 | 212018-002 | Apr 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-002 | Apr 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-001 | Apr 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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: ⤷ Sign Up
Australia
Patent: 16218000
Estimated Expiration: ⤷ Sign Up
Patent: 20250263
Estimated Expiration: ⤷ Sign Up
Patent: 22291429
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017017009
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 76356
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17002022
Estimated Expiration: ⤷ Sign Up
China
Patent: 7427511
Estimated Expiration: ⤷ Sign Up
Patent: 8290184
Estimated Expiration: ⤷ Sign Up
Patent: 3209102
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17008862
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 170411
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0211244
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 24432
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 56109
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 9646
Estimated Expiration: ⤷ Sign Up
Patent: 1791798
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 56109
Estimated Expiration: ⤷ Sign Up
Patent: 47143
Estimated Expiration: ⤷ Sign Up
Patent: 49954
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 56761
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3700
Estimated Expiration: ⤷ Sign Up
Patent: 1024
Estimated Expiration: ⤷ Sign Up
Patent: 0469
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 96588
Estimated Expiration: ⤷ Sign Up
Patent: 18505193
Estimated Expiration: ⤷ Sign Up
Patent: 21038241
Estimated Expiration: ⤷ Sign Up
Patent: 23011758
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 0200201
Estimated Expiration: ⤷ Sign Up
Patent: 95
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 56109
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 6599
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17010287
Estimated Expiration: ⤷ Sign Up
Patent: 21004110
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 496
Estimated Expiration: ⤷ Sign Up
Patent: 571
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 4516
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1700101
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017501421
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 56109
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 56109
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 221
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202000734Y
Estimated Expiration: ⤷ Sign Up
Patent: 201706472R
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 56109
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 170110145
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 83829
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 19960
Estimated Expiration: ⤷ Sign Up
Patent: 1630608
Estimated Expiration: ⤷ Sign Up
Patent: 2123939
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 3767
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 42142
Estimated Expiration: ⤷ Sign Up
Patent: 1515912
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| China | 102858765 | Pyrazolyl quinazoline kinase inhibitors | ⤷ Sign Up |
| Singapore | 11201706472R | 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 | ⤷ Sign Up |
| Brazil | 112017017009 | usos de um sequestrante de formaldeído e de uma composição farmacêutica, métodos para impedir, adiar, retardar ou diminuir a transformação de um composto e para tratar câncer, e, composição farmacêutica. | ⤷ Sign Up |
| New Zealand | 734516 | 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 | ⤷ Sign Up |
| Morocco | 41496 | COMPOSITIONS PHARMACEUTIQUES COMPRENANT LA N-(3,5-DIMÉTHOXYPHÉNYL)-N'-(1-MÉTHYLÉTHYL)-N-[3-(1-MÉTHYL-1H-PYRAZOL-4-YL)QUINOXALIN-6-YL]ÉTHANE-1,2-DIAMINE | ⤷ Sign Up |
| >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.
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