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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Novartis
Queensland Health
QuintilesIMS
Mallinckrodt
Farmers Insurance
Medtronic
AstraZeneca
Daiichi Sankyo
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Generated: September 26, 2017

DrugPatentWatch Database Preview

Hoffmann La Roche Company Profile

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What is the competitive landscape for HOFFMANN LA ROCHE, and when can generic versions of HOFFMANN LA ROCHE drugs launch?

HOFFMANN LA ROCHE has fourteen approved drugs.

There are fourteen US patents protecting HOFFMANN LA ROCHE drugs.

There are four hundred and eleven patent family members on HOFFMANN LA ROCHE drugs in fifty-two countries.

Summary for Applicant: Hoffmann La Roche

Patents:14
Tradenames:12
Ingredients:11
NDAs:14
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
FORTOVASE
saquinavir
CAPSULE;ORAL020828-001Nov 7, 1997DISCNYesNo► Subscribe► SubscribeY► Subscribe
Hoffmann La Roche
ROCEPHIN
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS050585-003Dec 21, 1984DISCNYesNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ROCEPHIN
ceftriaxone sodium
INJECTABLE;INJECTION063239-003Aug 13, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ROCEPHIN
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS050585-004Dec 21, 1984DISCNYesNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Hoffmann La Roche
ROCEPHIN
ceftriaxone sodium
INJECTABLE;INJECTION050585-005Dec 21, 1984DISCNYesNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Hoffmann La Roche

Paragraph IV activity for HOFFMANN LA ROCHE drugs

Drugname Dosage Strength Tradename Submissiondate
valganciclovir hydrochloride
For Oral Solution50 mg/mL
VALCYTE
3/21/2011
capecitabine
Tablets150 mg and 500 mg
XELODA
11/10/2008
ibandronate sodium
Injection1 mg/mL, 3 mL Vial
BONIVA
8/31/2007
ibandronate sodium
Tablets2.5 mg and 150 mg
BONIVA
5/16/2007
valganciclovir hydrochloride
Tablets450 mg
VALCYTE
12/27/2005

Premature patent expirations for HOFFMANN LA ROCHE

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Hoffmann La Roche

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
6,627,221 Pharmaceutical composition containing diphosphonic acid or salt thereof► Subscribe
8,329,724Process for the manufacture of pharmaceutically active compounds► Subscribe
8,415,469Compounds and methods for kinase modulation, and indications therefor► Subscribe
7,846,941Compounds modulating c-kit and c-fms activity and uses therefor► Subscribe
9,663,517Compositions and uses thereof► Subscribe
8,889,109Pharmaceutical dosage forms comprising valganciclovir hydrochloride► Subscribe
8,067,434Compounds and methods for development of Ret modulators► Subscribe
8,530,661Process for the manufacture of pharmaceutically active compounds► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Hoffmann La Roche Drugs

Country Document Number Estimated Expiration
Mexico2007016463► Subscribe
Costa Rica10822► Subscribe
Cyprus1117553► Subscribe
Australia751446► Subscribe
New Zealand563444► Subscribe
Norway328734► Subscribe
Panama8427301► Subscribe
China101223169► Subscribe
Austria518860► Subscribe
World Intellectual Property Organization (WIPO)0028942► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Hoffmann La Roche Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00045Netherlands► SubscribePRODUCT NAME: CAPECITABINE,DESGEWENST IN DE VORM VAN EEN SOLVAAT; NATL REGISTRATION NO/DATE: EU/1/00/163/001-002 20010202; FIRST REGISTRATION: CH 54657 19980610
2012010,C1893612Lithuania► SubscribePRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
C0040France► SubscribePRODUCT NAME: VEMURAFENIB, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
/1996Austria► SubscribePRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
C/GB01/015United Kingdom► SubscribePRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202
1893612/01Switzerland► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62139 18.10.2011
00534Netherlands► SubscribePRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
C/GB02/027United Kingdom► SubscribePRODUCT 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
2 5012-2012Slovakia► SubscribeFIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
90026-2Sweden► SubscribePRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Merck
AstraZeneca
Deloitte
Mallinckrodt
Chubb
Cipla
Baxter
Argus Health

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.

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