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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
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Accenture
Citi
Harvard Business School
Healthtrust
McKinsey
Deloitte
Mallinckrodt

Generated: December 11, 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 freedom to operate?

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

Insulin glulisine recombinant has two hundred and eighty-two patent family members in forty-two countries and forty-six supplementary protection certificates in twelve countries.

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

Summary for insulin glulisine recombinant

Pharmacology for insulin glulisine recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
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 UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAPIDRAinsulin glulisine recombinantINJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► 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
8,574,198Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,021,345Pen-type injector► Subscribe
8,876,782Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,905,867Pen-type injector► 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
9,526,843Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,070,727Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,205,197Drug delivery device dose setting mechanism► 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
Australia2004216828► Subscribe
Canada2748958► Subscribe
Portugal1920794► Subscribe
Denmark1920794► Subscribe
European Patent Office0885961► Subscribe
Japan2012515587► Subscribe
United Kingdom0308268► Subscribe
Portugal1601395► Subscribe
European Patent Office1601397► Subscribe
South Korea20060010721► 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
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
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
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
C/GB96/036United Kingdom► SubscribePRODUCT NAME: INSULIN LISPRO, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: CH 53290 19951123; CH 53553 19951123; UK EU/1/96/007/001 19960430; UK EU/1/96/007/002 19960430; UK EU/1/96/007/003 19960430
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Covington
Chinese Patent Office
Fuji
Cerilliant
Medtronic
Dow
Novartis
Fish and Richardson
Merck

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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