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Last Updated: December 26, 2024

JANSSEN BIOTECH Company Profile


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Summary for JANSSEN BIOTECH
International Patents:833
US Patents:35
Tradenames:5
Ingredients:5
NDAs:5
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 No 10,052,314 ⤷  Subscribe Y ⤷  Subscribe
Janssen Biotech LAZCLUZE lazertinib mesylate TABLET;ORAL 219008-002 Aug 19, 2024 RX Yes Yes 11,981,659 ⤷  Subscribe ⤷  Subscribe
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No 11,091,459 ⤷  Subscribe Y Y ⤷  Subscribe
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No 11,077,106 ⤷  Subscribe ⤷  Subscribe
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes 11,963,952 ⤷  Subscribe ⤷  Subscribe
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-002 Aug 11, 2023 RX Yes Yes 8,071,623 ⤷  Subscribe Y Y ⤷  Subscribe
>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
1633724 13/2015 Austria ⤷  Subscribe PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
2240466 132018000000301 Italy ⤷  Subscribe PRODUCT NAME: NIRAPARIB TOSILATO O UN SUO IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
2240466 300938 Netherlands ⤷  Subscribe DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2109608 122018000048 Germany ⤷  Subscribe PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, EINSCHLIESSLICH DES TOSYLATS DAVON; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2240466 SPC/GB18/018 United Kingdom ⤷  Subscribe PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTERED: UK EU/1/17/1235 20171120; UK PLGB 19494/0294 20171120
2109608 667 Finland ⤷  Subscribe
2368550 C201930040 Spain ⤷  Subscribe PRODUCT NAME: APALUTAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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