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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
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US Army
Covington
AstraZeneca
Farmers Insurance
Accenture
Julphar
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Generated: July 23, 2017

DrugPatentWatch Database Preview

APIDRA SOLOSTAR Drug Profile

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Which patents cover Apidra Solostar, and when can generic versions of Apidra Solostar launch?

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

This drug has two hundred and twenty-one patent family members in forty-two countries.

The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

Summary for Tradename: APIDRA SOLOSTAR

Patents:19
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list30
Drug Prices:see details
DailyMed Link:APIDRA SOLOSTAR at DailyMed

Pharmacology for Tradename: APIDRA SOLOSTAR

Ingredient-typeInsulin
Drug ClassInsulin Analog
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;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo7,918,833► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo6,960,561► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo9,526,844► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo9,561,331► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo8,992,486► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: APIDRA 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
9,604,009Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,526,843Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,205,276Zinc-free and low-zinc insulin preparations having improved stability► 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: APIDRA SOLOSTAR

Country Document Number Estimated Expiration
CroatiaP20050769► Subscribe
Austria422166► Subscribe
European Patent Office2221077► Subscribe
South Korea20060010722► Subscribe
Austria394133► 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: APIDRA SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2004005,C0792290Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
13/34Ireland► SubscribePRODUCT: 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
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Deloitte
Fuji
UBS
Covington
McKesson
Johnson and Johnson
Medtronic
Baxter
Moodys

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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