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Last Updated: November 13, 2019

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JANSSEN PRODS Company Profile

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Summary for JANSSEN PRODS
International Patents:940
US Patents:34
Tradenames:6
Ingredients:6
NDAs:7

Drugs and US Patents for JANSSEN PRODS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes 7,700,645   Start Trial Y Y   Start Trial
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes 9,296,769   Start Trial Y Y   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 DISCN Yes No 8,518,987*PED   Start Trial Y   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 AB RX Yes No 7,470,506*PED   Start Trial 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

Expired US Patents for JANSSEN PRODS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 RE43596*PED   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 RE43802*PED   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 5,843,946*PED   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 RE43596*PED   Start Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 6,248,775*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for JANSSEN PRODS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 800 mg ➤ Subscribe 2013-05-14

Supplementary Protection Certificates for JANSSEN PRODS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 1690062-3 Sweden   Start Trial PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1632232 PA2016042 Lithuania   Start Trial PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152 C 2012 015 Romania   Start Trial PRODUCT NAME: RILPIVIRINA SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA RILPIVIRINEI CU ACIDULCLORHIDRIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/736/001; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/736/001; DATE OF FIRST AUTHORISATION IN EEA: 20111128
0513200 C00513200/01 Switzerland   Start Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1301519 CA 2016 00012 Denmark   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
>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:

Johnson and Johnson
AstraZeneca
McKesson
Moodys
Mallinckrodt
Medtronic

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