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Last Updated: July 16, 2024

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 Pharms DURAGESIC-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-003 Aug 7, 1990 DISCN Yes No ⤷  Sign Up ⤷  Sign Up
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up
Janssen Pharms PONVORY ponesimod TABLET;ORAL 213498-004 Mar 18, 2021 RX Yes No RE43728 ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Pharms ORTHO CYCLEN-28 ethinyl estradiol; norgestimate TABLET;ORAL-28 019653-002 Dec 29, 1989 DISCN Yes No ⤷  Sign Up ⤷  Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up
Janssen Pharms PONVORY ponesimod TABLET;ORAL 213498-003 Mar 18, 2021 RX Yes No 10,220,023 ⤷  Sign Up ⤷  Sign Up
>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 LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 5,053,407*PED ⤷  Sign Up
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 7,887,845*PED ⤷  Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 5,082,668*PED ⤷  Sign Up
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 6,077,843*PED ⤷  Sign Up
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990 4,144,317 ⤷  Sign Up
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-004 Dec 23, 2004 5,648,093*PED ⤷  Sign Up
>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 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
➤ 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

Supplementary Protection Certificates for JANSSEN Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 CA 2015 00055 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1912999 CA 2014 00053 Denmark ⤷  Sign Up PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
3533792 CA 2021 00041 Denmark ⤷  Sign Up PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2487163 SPC/GB17/010 United Kingdom ⤷  Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTERED: UK EU/1/15/1025/001 20150715; UK EU/1/15/1025/002 20150715
2049506 C20150046 00250 Estonia ⤷  Sign Up PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013
0836511 CA 2006 00019 Denmark ⤷  Sign Up PRODUCT NAME: FENTANYL HYDROCHLORID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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