Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 21, 2019

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

This drug has two hundred and ninety-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.

Recent Clinical Trials for XULTOPHY 100/3.6

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SponsorPhase
Novo Nordisk A/SN/A

See all XULTOPHY 100/3.6 clinical trials

Recent Litigation for XULTOPHY 100/3.6

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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
>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
2498802 17C0004 France   Start Trial PRODUCT NAME: INSULINE GLARGINE ET LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2209800 SPC/GB14/079 United Kingdom   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
0214826 99C0044 Belgium   Start Trial PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
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Johnson and Johnson
Moodys
Medtronic

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