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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Federal Trade Commission
Cerilliant
McKinsey
Mallinckrodt
Medtronic
Chinese Patent Office
Johnson and Johnson

Generated: July 16, 2018

DrugPatentWatch Database Preview

XULTOPHY 100/3.6 Drug Profile

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When do Xultophy 100/3.6 patents expire, and when can generic versions of Xultophy 100/3.6 launch?

Xultophy 100/3.6 is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are fifteen patents protecting this drug.

This drug has two hundred and fifty-six patent family members in twenty-seven countries.

The generic ingredient in XULTOPHY 100/3.6 is insulin degludec; liraglutide. There are thirty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin degludec; liraglutide profile page.
Drug patent expirations by year for XULTOPHY 100/3.6
Generic Entry Opportunity Date for XULTOPHY 100/3.6
Generic Entry Date for XULTOPHY 100/3.6*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for XULTOPHY 100/3.6

US Patents and Regulatory Information for XULTOPHY 100/3.6

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 XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 XULTOPHY 100/3.6

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for XULTOPHY 100/3.6

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 ➤ Try a Free Trial
8,097,698 Derivatives of GLP-1 analogs ➤ Try a Free Trial
8,828,923 Insulin derivatives ➤ Try a Free Trial
6,384,016 Stabilized aqueous peptide solutions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for XULTOPHY 100/3.6

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017000040 Germany ➤ Try a Free Trial PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
00596 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
2107069/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
C034/2009 Ireland ➤ Try a Free Trial SPC034/2009: 20101001, EXPIRES: 20220821
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
Harvard Business School
US Army
Daiichi Sankyo
Accenture
Express Scripts
Dow
Teva

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