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Last Updated: January 22, 2020

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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 and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has three hundred and three 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.

US ANDA Litigation and Generic Entry Outlook for Xultophy 100/3.6

  Start Trial

Xultophy 100/3.6 was eligible for patent challenges on September 25th, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 28th, 2029. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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.

Recent Clinical Trials for XULTOPHY 100/3.6

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

SponsorPhase
Novo Nordisk A/SN/A

See all XULTOPHY 100/3.6 clinical trials

Recent Litigation for XULTOPHY 100/3.6

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08

See all XULTOPHY 100/3.6 litigation

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 XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 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 XULTOPHY 100/3.6

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016   Start Trial   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for XULTOPHY 100/3.6

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368187 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
2597103 CR 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
2107069 C300597 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
2107069 C20130013 00086 Estonia   Start Trial PRODUCT NAME: DEGLUDEKINSULIIN;REG NO/DATE: (2013) 637 (LOPLIK) COR. 21.01.2013
2107069 138 5015-2013 Slovakia   Start Trial PRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121
2107069 C20130014 00133 Estonia   Start Trial PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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