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Last Updated: April 6, 2020

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NOVOLOG FLEXTOUCH Drug Profile


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Which patents cover Novolog Flextouch, and when can generic versions of Novolog Flextouch launch?

Novolog Flextouch is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in seventeen countries.

The generic ingredient in NOVOLOG FLEXTOUCH is insulin aspart recombinant. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Novolog Flextouch

Novolog Flextouch was eligible for patent challenges on June 7, 2004.

Indicators of Generic Entry

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Summary for NOVOLOG FLEXTOUCH
Drug patent expirations by year for NOVOLOG FLEXTOUCH
Recent Litigation for NOVOLOG FLEXTOUCH

Identify potential future generic entrants

District Court Litigation
Case NameDate
SMITH v. NOVO NORDISK INC.2016-08-08

See all NOVOLOG FLEXTOUCH litigation

Pharmacology for NOVOLOG FLEXTOUCH
Drug ClassInsulin Analog

US Patents and Regulatory Information for NOVOLOG FLEXTOUCH

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 FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes 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 NOVOLOG FLEXTOUCH

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NOVOLOG FLEXTOUCH

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 C300698 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2340033 300880 Netherlands   Start Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
0885961 SZ 2/2005 Austria   Start Trial PRODUCT NAME: INSULIN GLULISINE
2107069 13C0035 France   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2107069 2013C/035 Belgium   Start Trial PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121
2107069 2013/34 Ireland   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Medtronic
McKesson
Express Scripts
Moodys

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 verification 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.