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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Chubb
Dow
Colorcon
Accenture
McKinsey
McKesson
Fish and Richardson
UBS
Citi

Generated: September 25, 2017

DrugPatentWatch Database Preview

Sanofi Company Profile

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What is the competitive landscape for SANOFI, and what generic alternatives to SANOFI drugs are available?

SANOFI has one hundred and forty-six approved drugs.

There are sixty-nine US patents protecting SANOFI drugs.

There are one thousand three hundred and seventy patent family members on SANOFI drugs in seventy-five countries.

Summary for Applicant: Sanofi

Patents:69
Tradenames:120
Ingredients:97
NDAs:146
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
PRESAMINE
imipramine hydrochloride
TABLET;ORAL011836-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
ISUPREL
isoproterenol hydrochloride
SOLUTION;INHALATION006327-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
LOVENOX (PRESERVATIVE FREE)
enoxaparin sodium
INJECTABLE;SUBCUTANEOUS020164-001Mar 29, 1993APRXYesNo► Subscribe► Subscribe► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Sanofi Aventis Us
MYTELASE
ambenonium chloride
TABLET;ORAL010155-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Sanofi

Paragraph IV activity for SANOFI drugs

Drugname Dosage Strength Tradename Submissiondate
nicotine
Transdermal System7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs
NICODERM CQ
5/30/2014
dronedarone hydrochloride
Tablets400 mg
MULTAQ
7/1/2013
oxaliplatin
Injection5 mg/mL, 40 mL vial
ELOXATIN
3/23/2011
fexofenadine hydrochloride
Oral Suspension30 mg/5 mL
ALLEGRA
1/25/2010
docetaxel
Injection40 mg/mL, 0.5 mL and 2 mL vials
TAXOTERE
6/30/2009
clopidogrel bisulfate
Tablets300 mg
PLAVIX
3/4/2009
levocetirizine dihydrochloride
Oral Solution0.5 mg/mL
XYZAL
1/14/2009
levocetirizine dihydrochloride
Tablets5 mg
XYZAL
12/17/2007
ranitidine hydrochloride
Tablets150 mg
ZANTAC 150
10/30/2007
oxaliplatin
Injection200 mg/40 mL
ELOXATIN
7/16/2007
oxaliplatin
Injection5 mg/mL, 10 mL and 20 mL vials
ELOXATIN
2/9/2007
oxaliplatin
For Injection50 mg/vial and 100 mg/vial
ELOXATIN
2/9/2007
enoxaparin sodium
Injection100 mg/mL, 3 mL vials
LOVENOX
12/7/2006
irbesartan and hydrochlorothiazide
Tablets300 mg/25 mg
AVALIDE
6/6/2006
zolpidem tartrate
Extended-release Tablets6.25 mg
AMBIEN CR
2/24/2006
zolpidem tartrate
Extended-release Tablets12.5 mg
AMBIEN CR
1/19/2006
irbesartan and hydrochlorothiazide
Tablets150 mg/12.5 mg and 300 mg/12.5 mg
AVALIDE
11/10/2004
irbesartan
Tablets75 mg, 150 mg and 300 mg
AVAPRO
5/25/2004

Premature patent expirations for SANOFI

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Sanofi

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
7,622,136Transparent transdermal nicotine delivery devices► Subscribe
8,574,198Drive mechanisms suitable for use in drug delivery devices► Subscribe
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient► Subscribe
6,100,404 Erythromycin compounds► Subscribe
6,528,486 Peptide agonists of GLP-1 activity► Subscribe
7,850,662Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
6,372,780 Methods of treating cell lines expressing multidrug resistance P-glycoprotein► Subscribe
6,387,946 Methods for treating pathological conditions of abnormal cell proliferation► Subscribe
6,331,635 Taxoids, their preparation and pharmaceutical compositions containing them► 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 Sanofi Drugs

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2011036134► Subscribe
Poland337348► Subscribe
South Africa201102400► Subscribe
South Korea20090117899► Subscribe
Singapore188423► Subscribe
Australia2012300978► Subscribe
Norway20082904► Subscribe
Slovakia281707► Subscribe
BrazilPI0910631► Subscribe
Bulgaria100951► 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 Sanofi Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
4Finland► Subscribe
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
366Luxembourg► SubscribePRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
2013000036Germany► SubscribePRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
00095Netherlands► SubscribePRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
2011 00026Denmark► SubscribePRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
C008/2010Ireland► SubscribeSPC008/2010: 20101015, EXPIRES: 20230616
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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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:

Deloitte
Argus Health
Merck
Chubb
Citi
Boehringer Ingelheim
Baxter
Julphar
Farmers Insurance
US Department of Justice

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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