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NORDITROPIN Drug Profile

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Norditropin is a drug marketed by Novo Nordisk Inc and is included in two NDAs. It is available from two suppliers. There are fifteen patents protecting this drug.

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:15
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: 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 NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-007Mar 10, 2009DISCNNo8,841,252► subscribeY ► subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010RXNo8,920,383► subscribeY ► subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010RXNo5,849,704► subscribeY ► subscribe
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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;INJECTION021148-001Jun 20, 20005,849,704► subscribe
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-002Jun 20, 20005,849,704► subscribe
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION019721-001May 8, 19955,633,352► subscribe
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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► 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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International Patent Family for Tradename: NORDITROPIN

Country Document Number Estimated Expiration
Japan2950617► subscribe
Russian Federation2122426► subscribe
China1096222► 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 Certificates for Tradename: NORDITROPIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C008/2003Ireland► subscribeSPC008/2003: 20030508, EXPIRES: 20121217
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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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