You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
McKinsey
Boehringer Ingelheim
Express Scripts
Medtronic

Last Updated: February 16, 2020

DrugPatentWatch Database Preview

Insulin aspart protamine recombinant; insulin aspart recombinant - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for insulin aspart protamine recombinant; insulin aspart recombinant and what is the scope of freedom to operate?

Insulin aspart protamine recombinant; insulin aspart recombinant is the generic ingredient in four branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart protamine recombinant; insulin aspart recombinant has one hundred patent family members in twenty-two countries.

There are forty drug master file entries for insulin aspart protamine recombinant; insulin aspart recombinant. Four suppliers are listed for this compound.

Recent Clinical Trials for insulin aspart protamine recombinant; insulin aspart recombinant

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

SponsorPhase
Vancouver General HospitalPhase 4
SanofiPhase 4
Novo Nordisk A/SPhase 4

See all insulin aspart protamine recombinant; insulin aspart recombinant clinical trials

Recent Litigation for insulin aspart protamine recombinant; insulin aspart recombinant

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.2017-08-08
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08

See all insulin aspart protamine recombinant; insulin aspart recombinant litigation

Pharmacology for insulin aspart protamine recombinant; insulin aspart recombinant
Drug ClassInsulin Analog

US Patents and Regulatory Information for insulin aspart protamine recombinant; insulin aspart recombinant

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 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-001 Nov 1, 2001 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-002 Nov 1, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 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 insulin aspart protamine recombinant; insulin aspart recombinant

Supplementary Protection Certificates for insulin aspart protamine recombinant; insulin aspart recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2498802 2017030 Norway   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
0705275 SPC/GB00/027 United Kingdom   Start Trial PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
0368187 C300019 Netherlands   Start Trial PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
0885961 SPC/GB05/024 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
McKesson
Medtronic
Dow
Mallinckrodt

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.