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APIDRA SOLOSTAR Drug Profile

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Which patents cover Apidra Solostar, and what substitute generic drugs are available?

Apidra 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 two hundred and nine 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:16
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list16
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 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, 2009RXYesNo6,221,633► SubscribeYY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo8,992,486► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo9,011,391► Subscribe ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo8,603,044► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo9,233,211► 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
8,888,750Pen-type injector► Subscribe
8,070,727Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,205,276Zinc-free and low-zinc insulin preparations having improved stability► Subscribe
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,574,198Drive 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: APIDRA SOLOSTAR

Country Document Number Estimated Expiration
European Patent Office2221077► Subscribe
Austria406929► Subscribe
Taiwan200510026► Subscribe
MexicoPA05009308► Subscribe
Spain2312975► 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
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
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
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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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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