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Moodys
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Last Updated: April 7, 2020

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LEVEMIR FLEXTOUCH Drug Profile


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

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

This drug has one hundred and eighty-six patent family members in twenty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Levemir Flextouch

Levemir Flextouch was eligible for patent challenges on June 16, 2009.

Annual sales in 2017 were $17mm indicating the motivation for generic entry (peak sales were $40mm in 2015).

Indicators of Generic Entry

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Drug patent expirations by year for LEVEMIR FLEXTOUCH
Drug Prices for LEVEMIR FLEXTOUCH

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Drug Sales Revenue Trends for LEVEMIR FLEXTOUCH

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Recent Litigation for LEVEMIR FLEXTOUCH

Identify potential future generic entrants

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

See all LEVEMIR FLEXTOUCH litigation

Pharmacology for LEVEMIR FLEXTOUCH
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for LEVEMIR 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 LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes   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 LEVEMIR FLEXTOUCH

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEVEMIR FLEXTOUCH

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885961 05C0009 France   Start Trial PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
0368187 00C0023 France   Start Trial PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
2107069 132013902170499 Italy   Start Trial PRODUCT NAME: INSULINA DEGLUDEC(TRESIBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/807/001-4-5-7-8-9-12-13-15, 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Express Scripts
Johnson and Johnson
McKinsey
Baxter

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