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NORDITROPIN Drug Profile
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This drug has forty-three patent family members in twenty-seven countries.
The generic ingredient in NORDITROPIN is somatropin recombinant. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.
Summary for Tradename: NORDITROPIN
| Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 2 |
| Drug Prices: : | see details |
Pharmacology for Tradename: NORDITROPIN
| Ingredient-type | Recombinant Human Growth Hormones |
| Drug Class | Recombinant Human Growth Hormone |
Clinical Trials for: NORDITROPIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin recombinant | INJECTABLE;INJECTION | 021148-011 | Jan 23, 2015 | RX | No | 8,841,252 | Dec 26, 2017 | Y | |||||||||||||||||||
Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin recombinant | INJECTABLE;INJECTION | 021148-010 | Mar 1, 2010 | RX | No | 9,108,002 | Jan 20, 2026 | Y | |||||||||||||||||||
Novo Nordisk Inc | NORDITROPIN NORDIFLEX | somatropin recombinant | INJECTABLE;INJECTION | 021148-004 | Oct 1, 2004 | DISCN | No | 5,849,700 | Dec 15, 2015 | ||||||||||||||||||||
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Expired Patents for Tradename: NORDITROPIN
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | NORDITROPIN | somatropin recombinant | INJECTABLE;INJECTION | 019721-001 | May 8, 1995 | 5,633,352 | <disabled> | ||||||||||||||||||||||
Novo Nordisk Inc | NORDITROPIN | somatropin recombinant | INJECTABLE;INJECTION | 021148-002 | Jun 20, 2000 | 5,633,352 | <disabled> | ||||||||||||||||||||||
Novo Nordisk Inc | NORDITROPIN | somatropin recombinant | INJECTABLE;INJECTION | 021148-001 | Jun 20, 2000 | 5,849,704 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Tradename: NORDITROPIN
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,022,858 | Pharmaceutical formulation of human-growth hormone pretreated with zinc salt | <disabled in preview> | |||||||||||||||||||||||||||
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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 Tradename: NORDITROPIN
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | 368472 | <disabled in preview> | |||||||||||||||||||||||||||
| Israel | 104152 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2125855 | <disabled in preview> | |||||||||||||||||||||||||||
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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: NORDITROPIN
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