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Generated: September 26, 2017
What is the patent landscape for Novolog Flextouch, and what generic Novolog Flextouch alternatives are available?
Novolog Flextouch is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are eleven patents protecting this drug.| Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 3 |
| Clinical Trials: see list | 29 |
| Drug Prices: | see details |
| DailyMed Link: | NOVOLOG FLEXTOUCH at DailyMed |
| Ingredient-type | Insulin |
| Drug Class | Insulin Analog |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | ► Subscribe | ► Subscribe | ||||||||
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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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,357,120 | Injection device with torsion spring and rotatable display | ► Subscribe | |||||||||||||
| 9,616,180 | Automatic injection device with a top release mechanism | ► Subscribe | |||||||||||||
| 7,686,786 | Dial-down mechanism for wind-up pen | ► Subscribe | |||||||||||||
| 8,096,978 | Automatic injection device with a top release 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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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2258097 | ► Subscribe | |||||||||||||
| Japan | 5568157 | ► Subscribe | |||||||||||||
| Spain | 2334808 | ► Subscribe | |||||||||||||
| Austria | 296650 | ► Subscribe | |||||||||||||
| Australia | 2005298946 | ► Subscribe | |||||||||||||
| Israel | 182616 | ► Subscribe | |||||||||||||
| Russian Federation | 2007114760 | ► Subscribe | |||||||||||||
| Japan | 2004516895 | ► Subscribe | |||||||||||||
| Japan | 4698677 | ► Subscribe | |||||||||||||
| European Patent Office | 1843809 | ► 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0885961/01 | Switzerland | ► Subscribe | PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005 | ||||||||||||
| 00596 | Netherlands | ► Subscribe | PRODUCT 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 | ||||||||||||
| 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 | ||||||||||||
| /2004 | Austria | ► Subscribe | PRODUCT 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 | ||||||||||||
| 2014000114 | Germany | ► Subscribe | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 | ||||||||||||
| 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 | ||||||||||||
| 2209800/01 | Switzerland | ► Subscribe | PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014 | ||||||||||||
| C/GB05/024 | United Kingdom | ► Subscribe | PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929 | ||||||||||||
| 213 | Luxembourg | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE | ||||||||||||
| 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 | ||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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