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Serving hundreds of leading biopharmaceutical companies globally:

US Army
McKesson
QuintilesIMS
UBS
Medtronic
Daiichi Sankyo
Covington
Cipla
Boehringer Ingelheim

Generated: August 16, 2018

DrugPatentWatch Database Preview

Insulin aspart; insulin degludec - Generic Drug Details

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

Insulin aspart; insulin degludec is the generic ingredient in one branded drug marketed by Novo Nordisk Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart; insulin degludec has one hundred and forty-three patent family members in twenty-three countries.

There are forty drug master file entries for insulin aspart; insulin degludec.

Summary for insulin aspart; insulin degludec

US Patents and Regulatory Information for insulin aspart; insulin degludec

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 RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novo Nordisk Inc RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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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Non-Orange Book US Patents for insulin aspart; insulin degludec

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
7,686,786 Dial-down mechanism for wind-up pen ➤ Sign Up
9,861,757 Injection device with an end of dose feedback mechanism ➤ Sign Up
8,096,978 Automatic injection device with a top release mechanism ➤ Sign Up
9,616,180 Automatic injection device with a top release mechanism ➤ Sign Up
8,357,120 Injection device with torsion spring and rotatable display ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for insulin aspart; insulin degludec

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2004 Austria ➤ Sign Up PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
13/34 Ireland ➤ Sign Up PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
1 Finland ➤ Sign Up
213 Luxembourg ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Baxter
Queensland Health
QuintilesIMS
Argus Health
Daiichi Sankyo
Chubb
Colorcon

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