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Last Updated: May 28, 2020

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Hoffmann La Roche Company Profile


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Summary for Hoffmann La Roche
International Patents:307
US Patents:12
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 KIT ceftriaxone sodium; lidocaine INJECTABLE;INJECTION 050585-007 May 8, 1996 DISCN No No   Start Trial   Start Trial
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INJECTION 062654-003 Apr 30, 1987 DISCN No No   Start Trial   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 DISCN Yes No   Start Trial   Start Trial
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 050585-002 Dec 21, 1984 DISCN Yes No   Start Trial   Start Trial
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 050585-001 Dec 21, 1984 DISCN Yes No   Start Trial   Start Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Start Trial   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes   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 Hoffmann La Roche

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 5,472,949*PED   Start Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997 5,196,438*PED   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 4,464,394*PED   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 4,200,647   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 4,464,394*PED   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 4,927,814   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 4,335,125   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
1893612 2012/025 Ireland   Start Trial PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 12C0040 France   Start Trial PRODUCT NAME: VEMURAFENIB, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
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 122012000043 Germany   Start Trial PRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 462 Finland   Start Trial
1893612 C300534 Netherlands   Start Trial PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
0432695 32/1996 Austria   Start Trial PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
>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:

Dow
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McKesson
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Medtronic

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