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Last Updated: October 17, 2019

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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 ceftriaxone sodium INJECTABLE;INJECTION 062654-001 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 W/ DEXTROSE IN PLASTIC CONTAINER ceftriaxone sodium INJECTABLE;INJECTION 050624-003 Feb 11, 1987 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 ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Start Trial   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 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
>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 TABLET;ORAL 021304-001 Mar 29, 2001 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 020896-002 Apr 30, 1998 4,966,891   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 4,927,814   Start Trial
Hoffmann La Roche INVIRASE saquinavir mesylate CAPSULE;ORAL 020628-001 Dec 6, 1995 5,196,438*PED   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 6,294,196   Start Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 4,200,647   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 For Oral Solution 50 mg/mL ➤ Subscribe 2011-03-21
➤ Subscribe Tablets 2.5 mg and 150 mg ➤ Subscribe 2007-05-16
➤ 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
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 C20120016 00059 Estonia   Start Trial PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012
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
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
0034432 96C0048 Belgium   Start Trial PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
1893612 462 Finland   Start Trial
1893612 SPC/GB12/021 United Kingdom   Start Trial PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
0432695 C970013 Netherlands   Start Trial PRODUCT NAME: SAQUINAVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESYLAAT; 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:

McKesson
McKinsey
Merck
Johnson and Johnson
Express Scripts
AstraZeneca

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