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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Cipla
Citi
Colorcon
Farmers Insurance
AstraZeneca
US Department of Justice
Deloitte

Generated: July 23, 2018

DrugPatentWatch Database Preview

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

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What are the generic sources for insulin aspart protamine recombinant; insulin aspart recombinant and what is the scope of insulin aspart protamine recombinant; insulin aspart recombinant patent protection?

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are forty drug master file entries for insulin aspart protamine recombinant; insulin aspart recombinant. Two suppliers are listed for this compound.
Pharmacology for insulin aspart protamine recombinant; insulin aspart recombinant
Ingredient-typeInsulin
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 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-002 Nov 1, 2001 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-001 Nov 1, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for insulin aspart protamine recombinant; insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-001 Nov 1, 2001 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-001 Nov 1, 2001 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-002 Nov 1, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for insulin aspart protamine recombinant; insulin aspart recombinant

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,235,004 Injection syringe ➤ Sign Up
6,582,404 Dose setting limiter ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90067-4 Sweden ➤ Sign Up PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
00160 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
2017 00013 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2107069/02 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
UBS
McKinsey
Fuji
Citi
Colorcon
Express Scripts
Julphar
Healthtrust

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