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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Federal Trade Commission
Chubb
Cerilliant
Cantor Fitzgerald
QuintilesIMS
Chinese Patent Office
Deloitte
US Department of Justice

Generated: August 17, 2018

DrugPatentWatch Database Preview

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 Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 RX Yes Yes 7,470,506*PED ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 AB RX Yes Yes 9,000,038*PED ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms NIZORAL ketoconazole TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No 7,157,456 ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for JANSSEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms HALDOL haloperidol lactate INJECTABLE;INJECTION 015923-001 Approved Prior to Jan 1, 1982 3,438,991 ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 6,503,884*PED ➤ Try a Free Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 5,912,268*PED ➤ Try a Free Trial
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 4,942,162 ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 7,018,983*PED ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 RE43802*PED ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for JANSSEN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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 50 mg/500 mg, 50mg/1000 mg, 150mg/500 mg, and150 mg/1000 mg ➤ Subscribe 2017-03-29
➤ Subscribe Extended-release Capsules 8 mg ➤ Subscribe 2006-03-02
➤ Subscribe Tablets 10 mg, 15 mg, and 20 mg ➤ Subscribe 2015-07-01
➤ 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 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 6.25 mg and 12.5 mg ➤ Subscribe 2005-12-08
➤ Subscribe Tablets 500 mg ➤ Subscribe 2017-08-23
➤ Subscribe Tablets 100 mg and 300 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 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

Non-Orange Book US Patents for JANSSEN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,084,124 Substituted indazole-O-glucosides ➤ Try a Free Trial
7,799,345 Preparation of injectable suspensions having improved injectability ➤ Try a Free Trial
8,129,378 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Try a Free Trial
6,638,932 2,4-disubstituted triazine derivatives ➤ Try a Free Trial
9,402,851 Process for the preparation of a solid, orally administrable pharmaceutical composition ➤ Try a Free Trial
8,822,458 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for JANSSEN Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140034 00151 Estonia ➤ Try a Free Trial PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
90001-0 Sweden ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123
C/GB12/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF.; REGISTERED: UK EU/1/11/736/001 20111130
2016000104 Germany ➤ Try a Free Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0767 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
15/058 Ireland ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-EU/1/13/830/002 20130524
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Accenture
Deloitte
Farmers Insurance
Cipla
Fish and Richardson
Mallinckrodt
Boehringer Ingelheim
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.