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Last Updated: April 4, 2020

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NOVOLOG MIX 50/50 Drug Profile


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When do Novolog Mix 50/50 patents expire, and when can generic versions of Novolog Mix 50/50 launch?

Novolog Mix 50/50 is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in NOVOLOG MIX 50/50 is insulin aspart protamine recombinant; 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 protamine recombinant; insulin aspart recombinant profile page.

Drug patent expirations by year for NOVOLOG MIX 50/50
Recent Clinical Trials for NOVOLOG MIX 50/50

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

SponsorPhase
Gan and Lee Pharmaceuticals, USAPhase 1
Texas Diabetes & Endocrinology, P.A.Phase 3
Mylan Inc.Phase 3

See all NOVOLOG MIX 50/50 clinical trials

Recent Litigation for NOVOLOG MIX 50/50

Identify potential future generic entrants

District Court Litigation
Case NameDate
Basic Line, Inc.2010-01-20

See all NOVOLOG MIX 50/50 litigation

US Patents and Regulatory Information for NOVOLOG MIX 50/50

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 MIX 50/50 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021810-001 Aug 26, 2008 DISCN No No   Start Trial   Start Trial   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 MIX 50/50

Supplementary Protection Certificates for NOVOLOG MIX 50/50

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 1390036-0 Sweden   Start Trial PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
2107069 300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2498802 17C0004 France   Start Trial PRODUCT NAME: INSULINE GLARGINE ET LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2107069 C 2013 022 Romania   Start Trial PRODUCT NAME: COMBINATIE DE INSULINA DEGLUDEC SI INSULINA ASPART IN TOATEFORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001,EU/1/12/806/004,EU/1/12/806/005,EU/1/12/806/007,00; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, 00; DATE OF FIRST AUTHORISATION IN EEA: 20130121
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
0214826 99C0044 Belgium   Start Trial PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Harvard Business School
Johnson and Johnson
Mallinckrodt
Dow

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