Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

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NORDITROPIN NORDIFLEX Drug Profile

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Which patents cover Norditropin Nordiflex, and when can generic versions of Norditropin Nordiflex launch?

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. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the somatropin profile page.

US ANDA Litigation and Generic Entry Outlook for Norditropin Nordiflex

Norditropin Nordiflex was eligible for patent challenges on December 31st, 1968.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for NORDITROPIN NORDIFLEX
Recent Clinical Trials for NORDITROPIN NORDIFLEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novo Nordisk A/SPhase 1
Novo Nordisk A/SN/A
Novo Nordisk A/SPhase 2

See all NORDITROPIN NORDIFLEX clinical trials

Recent Litigation for NORDITROPIN NORDIFLEX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08
Novo Nordisk A/S v. Sanofi-Aventis2005-09-02

See all NORDITROPIN NORDIFLEX litigation

Pharmacology for NORDITROPIN NORDIFLEX

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

Expired US Patents for NORDITROPIN NORDIFLEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-005 Oct 1, 2004   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-007 Mar 10, 2009   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-004 Oct 1, 2004   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-007 Mar 10, 2009   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-006 Oct 1, 2004   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-007 Mar 10, 2009   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-006 Oct 1, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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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.