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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
US Army
Dow
Federal Trade Commission
Accenture
Daiichi Sankyo
McKinsey
Merck
Mallinckrodt

Generated: July 23, 2018

DrugPatentWatch Database Preview

NORDITROPIN NORDIFLEX Drug Profile

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Which patents cover Norditropin Nordiflex, and what generic alternatives are available?

Norditropin Nordiflex is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-three patent family members in twenty-two countries.

The generic ingredient in NORDITROPIN NORDIFLEX is somatropin recombinant. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.

US Patents and Regulatory Information for NORDITROPIN NORDIFLEX

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 NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-004 Oct 1, 2004 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-006 Oct 1, 2004 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-005 Oct 1, 2004 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-007 Mar 10, 2009 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NORDITROPIN NORDIFLEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-006 Oct 1, 2004 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-007 Mar 10, 2009 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-004 Oct 1, 2004 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-006 Oct 1, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for NORDITROPIN NORDIFLEX

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
6,582,404 Dose setting limiter ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Healthtrust
Daiichi Sankyo
McKesson
Accenture
Federal Trade Commission
Cerilliant
Express Scripts
Merck

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