Generic Balversa Availability

Last updated on Aug 7, 2024.

Balversa is a brand name of erdafitinib, approved by the FDA in the following formulation(s):

BALVERSA (erdafitinib - tablet;oral)

Manufacturer: JANSSEN BIOTECH
Approval date: April 12, 2019
Strength(s): 3MG ^[RLD], 4MG ^[RLD], 5MG ^[RLD]

Has a generic version of Balversa been approved?

No. There is currently no therapeutically equivalent version of Balversa available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Balversa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

FGFR/PD-1 combination therapy for the treatment of cancer
Patent 10,478,494
Issued: November 19, 2019
Inventor(s): Karkera Jayaprakash & Platero Suso Jesus & Verona Raluca & Lorenzi Matthew V.
Assignee(s): ASTEX THERAPEUTICS LTD
Provided herein are combination therapies for the treatment of cancer. In particular, the disclosed methods are directed to treatment of cancer in a patient comprising administering an antibody that blocks the interaction between PD-1 and PD-L1 and an FGFR inhibitor, wherein the antibody that blocks the interaction between PD-1 and PD-L1 and the FGFR inhibitor are administered if one or more FGFR variants are present in a biological sample from the patient.
Patent expiration dates:
- August 13, 2036
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  Patent use: TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PRIOR PD-1 OR PD-L1 INHIBITOR 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-diamine
Patent 10,898,482
Issued: January 26, 2021
Inventor(s): Broggini Diego Fernando Domenico
Assignee(s): ASTEX THERAPEUTICS LTD
The invention relates to 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, or a pharmaceutically acceptable salt thereof or a solvate thereof; to processes for the preparation of said compositions and to the use of said compositions for the manufacture of a medicament for the prophylaxis of or the treatment, in particular the treatment, of diseases, e.g. cancer.
Patent expiration dates:
- February 9, 2036
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  Patent 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
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  Drug product
- February 9, 2036
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  Patent 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
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  Drug product
- February 9, 2036
  ✓
  Patent 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
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  Drug product
- February 9, 2036
  ✓
  Patent 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
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  Drug product
- February 9, 2036
  ✓
  Patent 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
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  Drug product
- February 9, 2036
  ✓
  Patent 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
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  Drug product
- February 9, 2036
  ✓
  Patent 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
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  Drug product
Cancer treatment
Patent 11,077,106
Issued: August 3, 2021
Inventor(s): Stuyckens Kim & Perez Ruixo Juan Jose & De Porre Peter Marie Z. & Avadhani Anjali Narayan & Loriot Yohann & Siefker-Radtke Arlene O.
Assignee(s): Janssen Pharmaceutica NV
The present invention provides a method for the treatment of cancer with erdafitinib.
Patent expiration dates:
- February 2, 2038
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  Patent 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
- February 2, 2038
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  Patent 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 11,684,620
Patent expiration dates:
- February 9, 2036
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  Patent 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
- February 9, 2036
  ✓
  Patent 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
- February 9, 2036
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  Patent 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 8,895,601
Issued: November 25, 2014
Inventor(s): Saxty Gordon & Murray Christopher William & Berdini Valerio & Besong Gilbert Ebai & Hamlett Christopher Charles Frederick & Johnson Christopher Norbert & Woodhead Steven John & Rees David Charles & Mevellec Laurence Anne & Angibaud Patrick René & Freyne Eddy Jean Edgard & Pere
Assignee(s): Astex Therapeutics Ltd
The invention relates to new quinoxaline derivative compounds, to pharmaceutical compositions comprising said compounds, to processes for the preparation of said compounds and to the use of said compounds in the treatment of diseases, e.g. cancer.
Patent expiration dates:
- April 12, 2033
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  Drug substance
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  Drug product
Pyrazolyl quinoxaline kinase inhibitors
Patent 9,464,071
Issued: October 11, 2016
Inventor(s): Saxty Gordon & Murray Christopher William & Berdini Valerio & Besong Gilbert Ebai & Hamlett Christopher Charles Frederick & Johnson Christopher Norbert & Woodhead Steven John & Reader Michael & Rees David Charles & Mevellec Laurence Anne & Angibaud Patrick René & Freyne Eddy J
Assignee(s): ASTEX THERAPEUTICS LTD
The invention relates to new quinoxaline derivative compounds, to pharmaceutical compositions comprising said compounds, to processes for the preparation of said compounds and to the use of said compounds in the treatment of diseases, e.g. cancer.
Patent expiration dates:
- April 28, 2031
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  Patent 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 9,902,714
Issued: February 27, 2018
Inventor(s): Vermeulen Wim & Hostyn Steven Anna & Cuyckens Filip Albert Celine & Jones Russell Mark & Broggini Diego Fernando Domenico
Assignee(s): ASTEX THERAPEUTICS LTD
The invention relates to new quinoxaline derivative compounds of formula (I), to pharmaceutical compositions comprising said compounds, to processes for the preparation of said compounds and to the use of said compounds in the treatment of diseases, e.g. cancer.
Patent expiration dates:
- March 26, 2035
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  Drug product

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- April 12, 2024 - NEW CHEMICAL ENTITY
- January 19, 2027 - 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

More about Balversa (erdafitinib)

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Related treatment guides

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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