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Serving leading biopharmaceutical companies globally:

US Army
McKinsey
Johnson and Johnson
Teva
McKesson
Farmers Insurance
Cerilliant
Covington
Deloitte
Colorcon

Generated: December 14, 2017

DrugPatentWatch Database Preview

Insulin aspart recombinant - Generic Drug Details

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

Insulin aspart recombinant
is the generic ingredient in seven branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart recombinant has two hundred and twenty-six patent family members in twenty-three countries and forty-two supplementary protection certificates in twelve countries.

There are thirty-eight drug master file entries for insulin aspart recombinant. Three suppliers are listed for this compound.

Summary for insulin aspart recombinant

Pharmacology for insulin aspart recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Medical Subject Heading (MeSH) Categories for insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG INNOLETinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncFIASP FLEXTOUCHinsulin aspart recombinantSOLUTION;SUBCUTANEOUS208751-002Sep 29, 2017RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncFIASP FLEXTOUCHinsulin aspart recombinantSOLUTION;SUBCUTANEOUS208751-002Sep 29, 2017RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG PENFILLinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncFIASP FLEXTOUCHinsulin aspart recombinantSOLUTION;SUBCUTANEOUS208751-002Sep 29, 2017RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013► Subscribe► Subscribe
Novo Nordisk IncNOVOLOG PENFILLinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000► Subscribe► Subscribe
Novo Nordisk IncNOVOLOGinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-001Jun 7, 2000► Subscribe► Subscribe
Novo Nordisk IncNOVOLOG INNOLETinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004► Subscribe► Subscribe
Novo Nordisk IncNOVOLOG PENFILLinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000► Subscribe► Subscribe
Novo Nordisk IncNOVOLOG PENFILLinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000► Subscribe► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin aspart 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
6,235,004 Injection syringe► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
8,096,978Automatic injection device with a top release mechanism► Subscribe
9,616,180Automatic injection device with a top release mechanism► Subscribe
6,582,404 Dose setting limiter► 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 aspart recombinant

Country Document Number Estimated Expiration
China1374876► Subscribe
Germany69708121► Subscribe
Japan2010517650► Subscribe
South Korea20120047226► Subscribe
Germany602005017182► Subscribe
Japan2004516895► Subscribe
China101107031► Subscribe
Japan2010188167► Subscribe
Russian Federation2506957► Subscribe
Norway320213► 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 ASPART RECOMBINANT

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:

Chinese Patent Office
Dow
Accenture
Baxter
Covington
AstraZeneca
Daiichi Sankyo
Colorcon
Merck
Deloitte

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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