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Generated: August 17, 2017
What is the competitive landscape for SANOFI AVENTIS US, and when can generic versions of SANOFI AVENTIS US drugs launch?
SANOFI AVENTIS US has one hundred and thirty-six approved drugs.| Patents: | 56 |
| Tradenames: | 113 |
| Ingredients: | 93 |
| NDAs: | 136 |
| 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 | TACE | chlorotrianisene | CAPSULE;ORAL | 016235-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sanofi Aventis Us | ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872-007 | Jan 24, 2011 | OTC | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081-002 | Apr 27, 2007 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sanofi Aventis Us | ORNIDYL | eflornithine hydrochloride | INJECTABLE;INJECTION | 019879-002 | Nov 28, 1990 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi Aventis Us | KERLEDEX | betaxolol hydrochloride; chlorthalidone | TABLET;ORAL | 019807-001 | Oct 30, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | ALLEGRA ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 020872-010 | Jan 24, 2011 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | LOZOL | indapamide | TABLET;ORAL | 018538-001 | Jul 6, 1983 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-002 | Dec 16, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
nicotine | Transdermal System | 7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs | NICODERM CQ | 5/30/2014 |
dronedarone hydrochloride | Tablets | 400 mg | MULTAQ | 7/1/2013 |
oxaliplatin | Injection | 5 mg/mL, 40 mL vial | ELOXATIN | 3/23/2011 |
fexofenadine hydrochloride | Oral Suspension | 30 mg/5 mL | ALLEGRA | 1/25/2010 |
docetaxel | Injection | 40 mg/mL, 0.5 mL and 2 mL vials | TAXOTERE | 6/30/2009 |
clopidogrel bisulfate | Tablets | 300 mg | PLAVIX | 3/4/2009 |
oxaliplatin | Injection | 200 mg/40 mL | ELOXATIN | 7/16/2007 |
oxaliplatin | Injection | 5 mg/mL, 10 mL and 20 mL vials | ELOXATIN | 2/9/2007 |
oxaliplatin | For Injection | 50 mg/vial and 100 mg/vial | ELOXATIN | 2/9/2007 |
enoxaparin sodium | Injection | 100 mg/mL, 3 mL vials | LOVENOX | 12/7/2006 |
irbesartan and hydrochlorothiazide | Tablets | 300 mg/25 mg | AVALIDE | 6/6/2006 |
zolpidem tartrate | Extended-release Tablets | 6.25 mg | AMBIEN CR | 2/24/2006 |
zolpidem tartrate | Extended-release Tablets | 12.5 mg | AMBIEN CR | 1/19/2006 |
irbesartan and hydrochlorothiazide | Tablets | 150 mg/12.5 mg and 300 mg/12.5 mg | AVALIDE | 11/10/2004 |
irbesartan | Tablets | 75 mg, 150 mg and 300 mg | AVAPRO | 5/25/2004 |
| Patent Number | Expiration Date |
|---|---|
| ► Subscribe | ► Subscribe |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,553,299 | Drive mechanisms suitable for use in drug delivery devices | ► Subscribe | |||||||||||||||||||||||||||
| 6,232,477 | Methods of preparing new taxoids and pharmaceutical compositions containing them | ► Subscribe | |||||||||||||||||||||||||||
| 8,574,198 | Drive mechanisms suitable for use in drug delivery devices | ► Subscribe | |||||||||||||||||||||||||||
| 8,876,782 | Drive mechanisms suitable for use in drug delivery devices | ► Subscribe | |||||||||||||||||||||||||||
| 6,046,322 | Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5% | ► 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Uruguay | 27244 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2009144551 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1037319 | ► Subscribe | |||||||||||||||||||||||||||
| Luxembourg | 92172 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 9811338 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 13/34 | Ireland | ► Subscribe | PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013 | ||||||||||||||||||||||||||
| /2013 | Austria | ► Subscribe | PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317 | ||||||||||||||||||||||||||
| C0036 | France | ► Subscribe | PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001 | ||||||||||||||||||||||||||
| 14/032 | Ireland | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 | ||||||||||||||||||||||||||
| C0055 | France | ► Subscribe | PRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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