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Generated: June 28, 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 | 5,365 |
| 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 PENFILL | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-002 | Jun 7, 2000 | RX | Yes | Yes | 5,866,538*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | 9,486,588 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG INNOLET | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-004 | Apr 23, 2004 | DISCN | No | No | 5,866,538*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXPEN | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-003 | Jan 19, 2001 | RX | Yes | Yes | 6,004,297 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novo Nordisk Inc | NOVOLOG FLEXPEN | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-003 | Jan 19, 2001 | RX | Yes | Yes | RE41956 | ► 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 | 5,626,566*PED | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-001 | Jun 7, 2000 | 5,618,913*PED | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG INNOLET | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-004 | Apr 23, 2004 | 5,618,913*PED | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG PENFILL | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-002 | Jun 7, 2000 | 5,618,913*PED | ► Subscribe | ||||||||||||||||||||||
Novo Nordisk Inc | NOVOLOG PENFILL | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-002 | Jun 7, 2000 | 5,693,027*PED | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,096,978 | Automatic injection device with a top release mechanism | ► Subscribe | |||||||||||||||||||||||||||
| 7,686,786 | Dial-down mechanism for wind-up pen | ► Subscribe | |||||||||||||||||||||||||||
| 6,235,004 | Injection syringe | ► Subscribe | |||||||||||||||||||||||||||
| 6,582,404 | Dose setting limiter | ► Subscribe | |||||||||||||||||||||||||||
| 8,357,120 | Injection device with torsion spring and rotatable display | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 1351732 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 189964 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101300496 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 9904031 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 9906857 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0596 | Netherlands | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123 | ||||||||||||||||||||||||||
| 90036-0 | Sweden | ► Subscribe | PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121 | ||||||||||||||||||||||||||
| 13/34 | Ireland | ► Subscribe | PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013 | ||||||||||||||||||||||||||
| 226 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121 | ||||||||||||||||||||||||||
| 2004005 | Lithuania | ► Subscribe | PRODUCT NAME: INSULIN DETEMIR | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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