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McKesson
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Daiichi Sankyo
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US Army

Generated: March 20, 2019

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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 seventeen patents protecting this drug.

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

The generic ingredient in XULTOPHY 100/3.6 is insulin degludec; liraglutide. There are forty 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 ➤ 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
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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International Patents for XULTOPHY 100/3.6

Supplementary Protection Certificates for XULTOPHY 100/3.6

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 300883 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
0792290 04C0020 France ➤ Try a Free Trial PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
2107069 CA 2013 00033 Denmark ➤ Try a Free Trial
2107069 300596 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
0944648 CA 2009 00041 Denmark ➤ Try a Free Trial
0885961 05C0009 France ➤ Try a Free Trial PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Harvard Business School
Mallinckrodt
Chubb
Colorcon

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