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Last Updated: July 15, 2024

Erdafitinib - Generic Drug Details


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What are the generic sources for erdafitinib and what is the scope of freedom to operate?

Erdafitinib is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Erdafitinib has two hundred and three patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for erdafitinib
International Patents:203
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 27
Patent Applications: 672
What excipients (inactive ingredients) are in erdafitinib?erdafitinib excipients list
DailyMed Link:erdafitinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for erdafitinib
Generic Entry Date for erdafitinib*:
Constraining patent/regulatory exclusivity:
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 erdafitinib

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

SponsorPhase
Memorial Sloan Kettering Cancer CenterPhase 2
M.D. Anderson Cancer CenterPhase 2
University of WashingtonPhase 2

See all erdafitinib clinical trials

Paragraph IV (Patent) Challenges for ERDAFITINIB
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 erdafitinib

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 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 ⤷  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 erdafitinib

Country Patent Number Title Estimated Expiration
Japan 2013528580 ⤷  Sign Up
Mexico 2016012446 DERIVADOS DE QUINOXALINA UTILES COMO AMORTIGUADAORES DE RECEPTOR DEL FACTOR DE CRECIMIENTO DE FIBROBLASTOS (FGFR) CINASA. (QUINOXALINE DERIVATIVES USEFUL AS FGFR KINASE MODULATORS.) ⤷  Sign Up
Australia 2022291429 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
>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.