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Sanofi Aventis Us Company Profile
What is the competitive landscape for SANOFI AVENTIS US, and when can generic versions of SANOFI AVENTIS US drugs launch?
There are fifty-one US patents protecting SANOFI AVENTIS US drugs.
There are nine hundred and ninety-eight patent family members on SANOFI AVENTIS US drugs in seventy-one countries and one hundred and sixty-one supplementary protection certificates in fifteen countries.
Summary for Sanofi Aventis Us
| International Patents: | 998 |
| US Patents: | 51 |
| Tradenames: | 113 |
| Ingredients: | 93 |
| NDAs: | 136 |
Drugs and US Patents for Sanofi Aventis Us
| 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 | APIDRA SOLOSTAR | insulin glulisine recombinant | INJECTABLE;SUBCUTANEOUS | 021629-003 | Feb 24, 2009 | RX | Yes | No | 9,827,379 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sanofi Aventis Us | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | OTC | Yes | Yes | 6,039,974 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sanofi Aventis Us | SLO-BID | theophylline | CAPSULE, EXTENDED RELEASE;ORAL | 087893-001 | Jan 31, 1985 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Sanofi Aventis Us | APIDRA SOLOSTAR | insulin glulisine recombinant | INJECTABLE;SUBCUTANEOUS | 021629-003 | Feb 24, 2009 | RX | Yes | No | 7,452,860 | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 Sanofi Aventis Us
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-001 | Mar 29, 1993 | RE38743 | ➤ Sign Up |
| Sanofi Aventis Us | BRICANYL | terbutaline sulfate | TABLET;ORAL | 017618-002 | Approved Prior to Jan 1, 1982 | 4,011,258 | ➤ Sign Up |
| Sanofi Aventis Us | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | 6,037,353*PED | ➤ Sign Up |
| Sanofi Aventis Us | BRICANYL | terbutaline sulfate | TABLET;ORAL | 017618-001 | Approved Prior to Jan 1, 1982 | 4,011,258 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for SANOFI AVENTIS US drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 300 mg | ➤ Subscribe | 2009-03-04 |
| ➤ Subscribe | Tablets | 75 mg, 150 mg and 300 mg | ➤ Subscribe | 2004-05-25 |
| ➤ Subscribe | Tablets | 300 mg/25 mg | ➤ Subscribe | 2006-06-06 |
| ➤ Subscribe | For Injection | 50 mg/vial and 100 mg/vial | ➤ Subscribe | 2007-02-09 |
| ➤ Subscribe | Extended-release Tablets | 6.25 mg | ➤ Subscribe | 2006-02-24 |
| ➤ Subscribe | Injection | 40 mg/mL, 0.5 mL and 2 mL vials | ➤ Subscribe | 2009-06-30 |
| ➤ Subscribe | Injection | 5 mg/mL, 40 mL vial | ➤ Subscribe | 2011-03-23 |
| ➤ Subscribe | Transdermal System | 7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs | ➤ Subscribe | 2014-05-30 |
| ➤ Subscribe | Injection | 100 mg/mL, 3 mL vials | ➤ Subscribe | 2006-12-07 |
| ➤ Subscribe | Tablets | 150 mg/12.5 mg and 300 mg/12.5 mg | ➤ Subscribe | 2004-11-10 |
| ➤ Subscribe | Injection | 5 mg/mL, 10 mL and 20 mL vials | ➤ Subscribe | 2007-02-09 |
| ➤ Subscribe | Injection | 200 mg/40 mL | ➤ Subscribe | 2007-07-16 |
| ➤ Subscribe | Extended-release Tablets | 12.5 mg | ➤ Subscribe | 2006-01-19 |
| ➤ Subscribe | Oral Suspension | 30 mg/5 mL | ➤ Subscribe | 2010-01-25 |
| ➤ Subscribe | Tablets | 400 mg | ➤ Subscribe | 2013-07-01 |
Premature patent expirations for SANOFI AVENTIS US
Non-Orange Book US Patents for Sanofi Aventis Us
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 |
|---|---|---|
| 6,040,466 | Taxoids, their preparation and pharmaceutical compositions containing them | ➤ Sign Up |
| 6,187,916 | Process for the preparation of taxane derivatives and .beta.-lactam intermediates therefor | ➤ Sign Up |
| 6,218,553 | Process for the preparation of taxane derivatives and .beta.-lactam intermediates therefor | ➤ Sign Up |
| 6,004,582 | Multi-layered osmotic device | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Sanofi Aventis Us Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2003131187 | ➤ Sign Up |
| Algeria | 2009 | ➤ Sign Up |
| Germany | 69818607 | ➤ Sign Up |
| Spain | 2414639 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Sanofi Aventis Us Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0037 | France | ➤ Sign Up | PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322 |
| /1998 | Austria | ➤ Sign Up | PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715 |
| 14/032 | Ireland | ➤ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| C008/2010 | Ireland | ➤ Sign Up | SPC008/2010: 20101015, EXPIRES: 20230616 |
| 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.
Here is a list of applicants with similar names.
