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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Daiichi Sankyo
Argus Health
Moodys
Queensland Health
UBS
Federal Trade Commission
Farmers Insurance
Cerilliant

Generated: August 20, 2018

DrugPatentWatch Database Preview

STEGLUJAN Drug Profile

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When do Steglujan patents expire, and when can generic versions of Steglujan launch?

Steglujan is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and thirteen patent family members in fifty-one countries.

The generic ingredient in STEGLUJAN is ertugliflozin; sitagliptin phosphate. One supplier is listed for this compound. Additional details are available on the ertugliflozin; sitagliptin phosphate profile page.

Drug patent expirations by year for STEGLUJAN
Generic Entry Opportunity Date for STEGLUJAN
Generic Entry Date for STEGLUJAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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.

US Patents and Regulatory Information for STEGLUJAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Non-Orange Book US Patents for STEGLUJAN

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
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
9,044,424 Methods of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
9,439,902 Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives ➤ Sign Up
7,125,873 Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes ➤ Sign Up
8,669,380 Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for STEGLUJAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0041 France ➤ Sign Up PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
2008013,C1412357 Lithuania ➤ Sign Up PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
6 4-2007 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN; NAT. REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321; FIRST REGISTRATION: EU EU/1/07/383/001 - EU/1/07/383/018
5006-2008 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
0357 Netherlands ➤ Sign Up 300357, 20220705, EXPIRES: 20230715
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
US Department of Justice
Boehringer Ingelheim
Medtronic
Harvard Business School
QuintilesIMS
Cipla
Chinese Patent Office
Baxter

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.