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Generated: August 21, 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 | PERTOFRANE | desipramine hydrochloride | CAPSULE;ORAL | 013621-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081-001 | Apr 20, 2000 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081-001 | Apr 20, 2000 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Sanofi Aventis Us | DV | dienestrol | CREAM;VAGINAL | 083518-001 | Approved Prior to Jan 1, 1982 | 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 | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-003 | Aug 3, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | ALLEGRA | fexofenadine hydrochloride | SUSPENSION;ORAL | 021963-001 | Oct 16, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | PERTOFRANE | desipramine hydrochloride | CAPSULE;ORAL | 013621-002 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-006 | Jun 2, 2000 | ► 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 | |||||||||||||||||||||||||||
| 6,375,984 | Aqueous-based pharmaceutical composition | ► 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 | |||||||||||||||||||||||||||
| 8,070,727 | Drive mechanisms suitable for use in drug delivery devices | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | H06329692 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 9929710 | ► Subscribe | |||||||||||||||||||||||||||
| Uruguay | 27596 | ► Subscribe | |||||||||||||||||||||||||||
| France | 2764800 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1235568 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C008/2010 | Ireland | ► Subscribe | SPC008/2010: 20101015, EXPIRES: 20230616 | ||||||||||||||||||||||||||
| 2015 00004 | Denmark | ► Subscribe | PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718 | ||||||||||||||||||||||||||
| 8C0045 | Belgium | ► Subscribe | PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715 | ||||||||||||||||||||||||||
| C0085 | France | ► Subscribe | PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918 | ||||||||||||||||||||||||||
| 0885961/01 | Switzerland | ► Subscribe | PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005 | ||||||||||||||||||||||||||
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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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