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Last Updated: April 10, 2021

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Janssen Biotech Company Profile

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Summary for Janssen Biotech
International Patents:258
US Patents:12
Tradenames:3
Ingredients:3
NDAs:3

Drugs and US Patents for Janssen Biotech

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes 8,445,507   Start Trial Y Y   Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes 8,895,601   Start Trial Y Y   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes 8,802,689   Start Trial   Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No 9,902,714   Start Trial Y   Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No 9,464,071   Start Trial   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for JANSSEN BIOTECH drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 500 mg ➤ Subscribe 2017-08-23
➤ Subscribe Tablets 250 mg ➤ Subscribe 2015-04-28

Supplementary Protection Certificates for Janssen Biotech Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 C02368550/01 Switzerland   Start Trial PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67072 19.09.2019
2368550 35/2019 Austria   Start Trial PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
2368550 2019/032 Ireland   Start Trial PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT AUTHORISATION NO/DATE: EU/1/18/1342 20190114
2368550 C20190027 00294 Estonia   Start Trial PRODUCT NAME: APALUTAMIID;REG NO/DATE: EU/1/18/1342 16.01.2019
2368550 CA 2019 00029 Denmark   Start Trial PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
2368550 2019C/529 Belgium   Start Trial PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Johnson and Johnson
McKinsey
Moodys
McKesson

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.