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Serving leading biopharmaceutical companies globally:

Accenture
Boehringer Ingelheim
Baxter
McKesson
AstraZeneca
Express Scripts
Teva
Citi
QuintilesIMS
Argus Health

Generated: December 14, 2017

DrugPatentWatch Database Preview

LANTUS SOLOSTAR Drug Profile

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Which patents cover Lantus Solostar, and what generic alternatives are available?

Lantus Solostar is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are sixteen patents protecting this drug.

This drug has one hundred and ninety-five patent family members in twenty-seven countries and forty-two supplementary protection certificates in twelve countries.

The generic ingredient in LANTUS SOLOSTAR is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for LANTUS SOLOSTAR

Drug patent expirations by year for LANTUS SOLOSTAR

Pharmacology for LANTUS SOLOSTAR

Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsLANTUS SOLOSTARinsulin glargine recombinantINJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: LANTUS SOLOSTAR

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
8,070,727Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,623,190Pen-type injector► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,574,198Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,205,197Drug delivery device dose setting mechanism► Subscribe
8,663,175Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,021,345Pen-type injector► Subscribe
7,918,833Pen-type injector► Subscribe
8,876,782Drive 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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International Patent Family for Tradename: LANTUS SOLOSTAR

Country Document Number Estimated Expiration
SloveniaEP2263723► Subscribe
Portugal2263722► Subscribe
Spain2321460► Subscribe
Japan2012515587► Subscribe
Eurasian Patent Organization200501407► Subscribe
Slovenia1974761► Subscribe
European Patent Office1601395► Subscribe
South Africa200506658► Subscribe
Denmark1601395► Subscribe
Australia2010201305► 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 Tradename: LANTUS SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/036United Kingdom► SubscribePRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
00160Netherlands► SubscribePRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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Serving leading biopharmaceutical companies globally:

Colorcon
Cipla
Citi
Moodys
Johnson and Johnson
Teva
McKesson
Dow
AstraZeneca
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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