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Generated: September 21, 2017

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INSULIN GLULISINE RECOMBINANT - Generic Drug Details

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What are the generic drug sources for insulin glulisine recombinant and what is the scope of insulin glulisine recombinant patent protection?

Insulin glulisine recombinant
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glulisine recombinant has two hundred and thirty-six patent family members in forty-two countries.

There are thirty-eight drug master file entries for insulin glulisine recombinant. One supplier is listed for this compound.

Summary for Generic Name: INSULIN GLULISINE RECOMBINANT

Tradenames:2
Patents:19
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list5,441
Drug Prices:see low prices
DailyMed Link:INSULIN GLULISINE RECOMBINANT at DailyMed

Pharmacology for Ingredient: INSULIN GLULISINE RECOMBINANT

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, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin glulisine recombinant

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
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,205,276Zinc-free and low-zinc insulin preparations having improved stability► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,574,198Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,876,782Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,888,750Pen-type injector► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,623,190Pen-type injector► Subscribe
7,905,867Pen-type injector► 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 Ingredient: insulin glulisine recombinant

Country Document Number Estimated Expiration
Portugal2289539► Subscribe
Cyprus1114103► Subscribe
European Patent Office2289539► Subscribe
Spain2415854► Subscribe
Slovenia2266648► Subscribe
Norway326780► Subscribe
HungaryE032046► Subscribe
Australia2010201305► Subscribe
MexicoPA05009185► Subscribe
Germany19726167► 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: INSULIN GLULISINE RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
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
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2013000062Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Farmers Insurance
Dow
Cipla
Baxter
Chubb
Fish and Richardson
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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