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Last Updated: May 26, 2022

STEGLUJAN Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Steglujan

Steglujan was eligible for patent challenges on December 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.

There have been nine 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.

Indicators of Generic Entry

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Drug patent expirations by year for STEGLUJAN
Drug Prices for STEGLUJAN

See drug prices for STEGLUJAN

DrugPatentWatch® Estimated 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

STEGLUJAN is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STEGLUJAN is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting STEGLUJAN

Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES

FDA Regulatory Exclusivity protecting STEGLUJAN

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 STEGLUJAN

International Patents for STEGLUJAN

When does loss-of-exclusivity occur for STEGLUJAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 99
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10310956
Estimated Expiration: See Plans and Pricing

Canada

Patent: 77857
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120289
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150107
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15949
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 96583
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12011946
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1983
Estimated Expiration: See Plans and Pricing

Patent: 1290267
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 96583
Estimated Expiration: See Plans and Pricing

Japan

Patent: 96156
Estimated Expiration: See Plans and Pricing

Patent: 13509393
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 016
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9945
Estimated Expiration: See Plans and Pricing

Poland

Patent: 96583
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 96583
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 827
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 96583
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1203486
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1426180
Estimated Expiration: See Plans and Pricing

Patent: 120093321
Estimated Expiration: See Plans and Pricing

Spain

Patent: 27179
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3416
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering STEGLUJAN around the world.

Country Patent Number Title Estimated Expiration
Georgia, Republic of P20135803 DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES See Plans and Pricing
Ecuador SP044935 INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA BETA-AMINO HETEROCÍCLICA PARA EL TRATAMIENTO O LA PREVENCIÓN DE LA DIABETES See Plans and Pricing
Japan 2006516268 See Plans and Pricing
Eurasian Patent Organization 200501805 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STEGLUJAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 50/2008 Austria See Plans and Pricing PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1412357 106 4-2007 Slovakia See Plans and Pricing PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321
1412357 42/2007 Austria See Plans and Pricing PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
1412357 CA 2008 00035 Denmark See Plans and Pricing PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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 verification 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.