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Generated: October 20, 2017
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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.| US Patents: | 16 |
| Tradenames: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: see list | 38 |
| Suppliers / Packagers: see list | 3 |
| Clinical Trials: see list | 5,468 |
| Drug Prices: | see low prices |
| DailyMed Link: | insulin aspart recombinant at DailyMed |
| Ingredient-type | Insulin |
| Drug Class | Insulin Analog |
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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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,582,404 | Dose setting limiter | ► Subscribe | |||||||||||||
| 9,616,180 | Automatic injection device with a top release mechanism | ► Subscribe | |||||||||||||
| 8,357,120 | Injection device with torsion spring and rotatable display | ► Subscribe | |||||||||||||
| 7,686,786 | Dial-down mechanism for wind-up pen | ► Subscribe | |||||||||||||
| 6,235,004 | Injection syringe | ► Subscribe | |||||||||||||
| 8,096,978 | Automatic injection device with a top release mechanism | ► Subscribe | |||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Israel | 182616 | ► Subscribe | |||||||||||||
| Denmark | 0921812 | ► Subscribe | |||||||||||||
| Czech Republic | 20020927 | ► Subscribe | |||||||||||||
| European Patent Office | 2109474 | ► Subscribe | |||||||||||||
| China | 101084028 | ► Subscribe | |||||||||||||
| Czech Republic | 297361 | ► Subscribe | |||||||||||||
| Japan | 5340603 | ► Subscribe | |||||||||||||
| Japan | 5185620 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 0119434 | ► Subscribe | |||||||||||||
| Japan | 5431241 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2005 | Austria | ► Subscribe | PRODUCT 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 | ||||||||||||
| 00021 | Netherlands | ► Subscribe | PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623 | ||||||||||||
| C0009 | France | ► Subscribe | PRODUCT 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 | ||||||||||||
| C/GB04/036 | United Kingdom | ► Subscribe | PRODUCT 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 | ||||||||||||
| 2013000061 | Germany | ► Subscribe | PRODUCT 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 | ||||||||||||
| C/GB96/036 | United Kingdom | ► Subscribe | PRODUCT 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 | ||||||||||||
| 90042 | Netherlands | ► Subscribe | PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907 | ||||||||||||
| 2004005,C0792290 | Lithuania | ► Subscribe | PRODUCT 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 | ||||||||||||
| 00597 | Netherlands | ► Subscribe | PRODUCT 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 | ||||||||||||
| 00698 | Netherlands | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 | ||||||||||||
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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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