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Generated: August 19, 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 five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 38 |
| Suppliers / Packagers: see list | 3 |
| Clinical Trials: see list | 5,408 |
| Drug Prices: | see low prices |
| DailyMed Link: | insulin aspart recombinant at DailyMed |
| Ingredient-type | Insulin |
| Drug Class | Insulin 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 FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXPEN | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-003 | Jan 19, 2001 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | NOVOLOG PENFILL | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-002 | Jun 7, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-001 | Jun 7, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG PENFILL | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-002 | Jun 7, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG PENFILL | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-002 | Jun 7, 2000 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,686,786 | Dial-down mechanism for wind-up pen | ► Subscribe | |||||||||||||||||||||||||||
| 6,235,004 | Injection syringe | ► Subscribe | |||||||||||||||||||||||||||
| 8,357,120 | Injection device with torsion spring and rotatable display | ► Subscribe | |||||||||||||||||||||||||||
| 6,582,404 | Dose setting limiter | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2361563 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 1909870 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2584760 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 200201997 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 0202575 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0020 | France | ► Subscribe | PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110 | ||||||||||||||||||||||||||
| 90029-5 | Sweden | ► Subscribe | PRODUCT NAME: INSULIN DEGLUDEK | ||||||||||||||||||||||||||
| 00160 | Netherlands | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| C/GB00/027 | United Kingdom | ► Subscribe | PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801 | ||||||||||||||||||||||||||
| 90067-4 | Sweden | ► Subscribe | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918 | ||||||||||||||||||||||||||
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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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