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Serving leading biopharmaceutical companies globally:

UBS
Express Scripts
Chinese Patent Office
Daiichi Sankyo
Boehringer Ingelheim
Merck
Johnson and Johnson
Colorcon
Mallinckrodt
Covington

Generated: January 21, 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 seventeen patents protecting this drug.

This drug has two hundred and fifty-five 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.
Summary for XULTOPHY 100/3.6
Drug patent expirations by year for XULTOPHY 100/3.6
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 ➤ Subscribe ➤ Subscribe
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
8,357,120 Injection device with torsion spring and rotatable display ➤ Subscribe
6,384,016 Stabilized aqueous peptide solutions ➤ Subscribe
7,686,786 Dial-down mechanism for wind-up pen ➤ Subscribe
8,096,978 Automatic injection device with a top release mechanism ➤ Subscribe
9,616,180 Automatic injection device with a top release mechanism ➤ Subscribe
7,226,990 Extendin derivatives ➤ Subscribe
8,097,698 Derivatives of GLP-1 analogs ➤ Subscribe
8,828,923 Insulin derivatives ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for XULTOPHY 100/3.6

Supplementary Protection Certificates for XULTOPHY 100/3.6

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00021 Netherlands ➤ Subscribe PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
2013 00033 Denmark ➤ Subscribe
C/GB09/058 United Kingdom ➤ Subscribe PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
/2005 Austria ➤ Subscribe PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
2017 00013 Denmark ➤ Subscribe PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
C0009 France ➤ Subscribe 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
213 Luxembourg ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
C/GB96/036 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN LISPRO, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: CH 53290 19951123; CH 53553 19951123; UK EU/1/96/007/001 19960430; UK EU/1/96/007/002 19960430; UK EU/1/96/007/003 19960430
C/GB04/036 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
/2004 Austria ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Merck
Johnson and Johnson
Healthtrust
US Army
Daiichi Sankyo
Argus Health
Fuji
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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