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Last Updated: December 5, 2019

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NOVOLOG FLEXTOUCH Drug Profile

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When do Novolog Flextouch patents expire, and what generic alternatives are available?

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-five 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.

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
>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
2498802 C201730022 Spain   Start Trial PRODUCT NAME: SULIQUA-INSULINA GLARGINA/ LIXISENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1157; DATE OF AUTHORISATION: 20170111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1157; DATE OF FIRST AUTHORISATION IN EEA: 20170111
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2597103 CA 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Johnson and Johnson
Dow
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Medtronic

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