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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Express Scripts
Johnson and Johnson
Baxter
AstraZeneca

Last Updated: October 2, 2023

Erdafitinib - Generic Drug Details


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What are the generic drug 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 one hundred and eighty-one patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for erdafitinib
International Patents:181
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 50
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

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

Country Patent Number Title Estimated Expiration
Poland 3122742 ⤷  Try a Trial
Singapore 10202105110V CANCER TREATMENT ⤷  Try a Trial
Slovenia 2563775 ⤷  Try a Trial
Poland 2563775 ⤷  Try a Trial
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.) ⤷  Try a Trial
Eurasian Patent Organization 201500278 ПИРАЗОЛИЛХИНАЗОЛИНОВЫЕ ИНГИБИТОРЫ КИНАЗЫ ⤷  Try a Trial
Portugal 2563775 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Merck
Express Scripts
McKesson

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