Last Updated: July 17, 2026

JANSSEN Company Profile


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Summary for JANSSEN

Drugs and US Patents for JANSSEN

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 AB RX Yes No 11,963,952 ⤷  Start Trial ⤷  Start Trial
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-002 Aug 11, 2023 RX Yes Yes 11,091,459 ⤷  Start Trial Y Y ⤷  Start Trial
Janssen Pharms MICRONOR norethindrone TABLET;ORAL-28 016954-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-001 Mar 3, 1995 DISCN Yes No ⤷  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

Expired US Patents for JANSSEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 9,144,549 ⤷  Start Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 5,707,975 ⤷  Start Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 7,160,559 ⤷  Start Trial
Janssen Pharms ORTHO-NOVUM 7/7/7-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018985-002 Apr 4, 1984 4,544,554 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for JANSSEN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 50 mg ➤ Subscribe 2005-09-08
➤ Subscribe Transdermal System 0.15 mg/0.02 mg per 24 hours ➤ Subscribe 2007-03-22
➤ Subscribe Oral Solution 25 mg/mL ➤ Subscribe 2009-07-30
➤ Subscribe Orally Disintegrating Tablets 0.25 mg ➤ Subscribe 2005-04-11
➤ Subscribe Extended-release Injectable Suspension 39 mg/0.25 mL,78 mg/0.5 mL,117 mg/0.75 mL,156 mg/mL and234 mg/1.5 mL ➤ Subscribe 2017-11-21
➤ Subscribe Extended-release Tablets 18 mg*, 27 mg, 36 mg and 54 mg ➤ Subscribe 2005-07-19
➤ Subscribe Tablets 500 mg ➤ Subscribe 2017-08-23
➤ Subscribe Tablets 50 mg/500 mg, 50mg/1000 mg, 150mg/500 mg, and150 mg/1000 mg ➤ Subscribe 2017-03-29
➤ Subscribe Extended-release Capsules 16 mg and 24 mg ➤ Subscribe 2006-03-11
➤ Subscribe Tablets 800 mg ➤ Subscribe 2013-05-14
➤ Subscribe Tablets 25 mg, 100 mg and 200 mg ➤ Subscribe 2001-12-26
➤ Subscribe Capsules 15 mg and 25 mg ➤ Subscribe 2005-09-07
➤ Subscribe Tablets 10 mg, 15 mg, and 20 mg ➤ Subscribe 2015-07-01
➤ Subscribe Tablets 4 mg, 8 mg and 12 mg ➤ Subscribe 2005-02-28
➤ Subscribe Orally Disintegrating Tablets 3 mg and 4 mg ➤ Subscribe 2005-03-23
➤ Subscribe Extended-release Tablets 18 mg, 27 mg, 36 mg and 54 mg ➤ Subscribe 2005-07-19
➤ Subscribe Tablets 250 mg ➤ Subscribe 2015-04-28
➤ Subscribe Tablets 6.25 mg and 12.5 mg ➤ Subscribe 2005-12-08
➤ Subscribe Extended-release Capsules 8 mg ➤ Subscribe 2006-03-02
➤ Subscribe Tablets 100 mg and 300 mg ➤ Subscribe 2017-03-29
➤ Subscribe Oral Solution 10 mg/mL ➤ Subscribe 2013-05-03

Supplementary Protection Certificates for JANSSEN Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 2015/016 Ireland ⤷  Start Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1214076 C01214076/01 Switzerland ⤷  Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2563775 202540005 Slovenia ⤷  Start Trial PRODUCT NAME: ERDAFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A SOLVATE THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/24/1841; DATE OF NATIONAL AUTHORISATION: 20240822; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2368550 PA2019512,C2368550 Lithuania ⤷  Start Trial PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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