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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Medtronic
AstraZeneca
Moodys
Mallinckrodt

Last Updated: October 17, 2019

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Janssen Biotech Company Profile

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Summary for Janssen Biotech
International Patents:224
US Patents:11
Tradenames:3
Ingredients:3
NDAs:3
Patent Litigation for Janssen Biotech: See patent lawsuits for Janssen Biotech

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 10,052,314   Start Trial   Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 Apr 12, 2019 RX Yes No 8,895,601   Start Trial Y Y   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes 9,987,261   Start Trial Y   Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 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 8,895,601   Start Trial Y Y   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
0633893 2012/003 Ireland   Start Trial PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893 SPC/GB11/063 United Kingdom   Start Trial PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
2368550 122019000060 Germany   Start Trial PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114
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
2368550 LUC00123 Luxembourg   Start Trial PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-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:

Colorcon
Dow
Mallinckrodt
McKesson
Medtronic
Johnson and Johnson

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