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Serving leading biopharmaceutical companies globally:

Chubb
Julphar
Moodys
Argus Health
Merck
Deloitte
Cipla
Medtronic
Fish and Richardson
Federal Trade Commission

Generated: October 24, 2017

DrugPatentWatch Database Preview

Insulin aspart protamine recombinant; insulin aspart recombinant - Generic Drug Details

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What are the generic drug sources for insulin aspart protamine recombinant; insulin aspart recombinant and what is the scope of insulin aspart protamine recombinant; insulin aspart recombinant freedom to operate?

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

Insulin aspart protamine recombinant; insulin aspart recombinant has one hundred and four patent family members in twenty-two countries and forty supplementary protection certificates in twelve countries.

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

Summary for Generic Name: insulin aspart protamine recombinant; insulin aspart recombinant

US Patents:5
Tradenames:4
Applicants:1
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list2
Clinical Trials: see list5,494
Drug Prices:see low prices
DailyMed Link:insulin aspart protamine recombinant; insulin aspart recombinant at DailyMed

Pharmacology for Ingredient: insulin aspart protamine recombinant; insulin aspart 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
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 2001DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 2001RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin aspart protamine recombinant; 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
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 protamine recombinant; insulin aspart recombinant

Country Document Number Estimated Expiration
Brazil0014030► Subscribe
European Patent Office1003581► Subscribe
Czech Republic20020927► Subscribe
Spain2351778► Subscribe
China1120019► Subscribe
Japan5634068► Subscribe
European Patent Office2109474► Subscribe
Denmark1570876► Subscribe
BrazilPI0806854► Subscribe
South Africa9705470► 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 PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
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
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
00596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Chubb
US Department of Justice
Colorcon
QuintilesIMS
Argus Health
Teva
Merck
Covington

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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