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Last Updated: January 28, 2020

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Hoffmann La Roche Company Profile

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Summary for Hoffmann La Roche
International Patents:348
US Patents:13
Tradenames:11
Ingredients:10
NDAs:13

Drugs and US Patents for Hoffmann La Roche

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER ceftriaxone sodium INJECTABLE;INJECTION 050624-003 Feb 11, 1987 DISCN Yes No   Start Trial   Start Trial
Hoffmann La Roche INVIRASE saquinavir mesylate CAPSULE;ORAL 020628-001 Dec 6, 1995 DISCN Yes No   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes 7,410,957   Start Trial   Start Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes 8,470,818   Start Trial   Start Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes 7,504,509   Start Trial Y Y   Start Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes 8,741,920   Start Trial Y 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 Hoffmann La Roche

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 6,083,953*PED   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 4,322,438   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 4,966,891   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 6,294,196   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 4,200,647   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 5,472,949*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for HOFFMANN LA ROCHE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 450 mg ➤ Subscribe 2005-12-27
➤ Subscribe Injection 1 mg/mL, 3 mL Vial ➤ Subscribe 2007-08-31
➤ Subscribe Tablets 150 mg and 500 mg ➤ Subscribe 2008-11-10
➤ Subscribe For Oral Solution 50 mg/mL ➤ Subscribe 2011-03-21
➤ Subscribe Tablets 2.5 mg and 150 mg ➤ Subscribe 2007-05-16
Premature patent expirations for HOFFMANN LA ROCHE

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
  Start Trial   Start Trial

Supplementary Protection Certificates for Hoffmann La Roche Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 SPC/GB02/027 United Kingdom   Start Trial PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
0316704 2001C/021 Belgium   Start Trial PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
0316704 SPC/GB01/015 United Kingdom   Start Trial PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202
1893612 2012C/028 Belgium   Start Trial PRODUCT NAME: VERMURAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/751/001 20120221
1893612 C20120016 00059 Estonia   Start Trial PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012
1893612 28/2012 Austria   Start Trial PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

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McKesson
Mallinckrodt
Merck
Harvard Business School

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