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Last Updated: September 27, 2022

STEGLATRO Drug Patent Profile


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

Steglatro is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in forty-eight countries.

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

DrugPatentWatch® Generic Entry Outlook for Steglatro

Steglatro 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 July 13, 2030. This may change due to patent challenges or generic licensing.

There have been three 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 STEGLATRO
Drug Prices for STEGLATRO

See drug prices for STEGLATRO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for STEGLATRO
Generic Entry Date for STEGLATRO*:
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.

Recent Clinical Trials for STEGLATRO

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

SponsorPhase
Klinikum Wiener NeustadtPhase 3
General Hospital LinzPhase 3
Medical University of ViennaPhase 3

See all STEGLATRO clinical trials

Paragraph IV (Patent) Challenges for STEGLATRO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STEGLATRO Tablets ertugliflozin 5 mg and 15 mg 209803 3 2021-12-20

US Patents and Regulatory Information for STEGLATRO

STEGLATRO is protected by one US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STEGLATRO 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 STEGLATRO

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 STEGLATRO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
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
Msd Sub Merck STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Sub Merck STEGLATRO ertugliflozin TABLET;ORAL 209803-002 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Sub Merck STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Sub Merck STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Sub Merck STEGLATRO ertugliflozin TABLET;ORAL 209803-002 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Sub Merck STEGLATRO ertugliflozin TABLET;ORAL 209803-002 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

EU/EMA Drug Approvals for STEGLATRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Steglatro ertugliflozin EMEA/H/C/004315
Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:, , , as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications., in addition to other medicinal products for the treatment of diabetes., ,
Authorised no no no 2018-03-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for STEGLATRO

When does loss-of-exclusivity occur for STEGLATRO?

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

African Regional IP Organization (ARIPO)

Patent: 28
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 3138
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09286380
Estimated Expiration: See Plans and Pricing

Austria

Patent: 0040
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0918841
Estimated Expiration: See Plans and Pricing

Canada

Patent: 33795
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11000394
Estimated Expiration: See Plans and Pricing

China

Patent: 2149717
Estimated Expiration: See Plans and Pricing

Patent: 3497199
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 41636
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 110077
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120104
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 003
Estimated Expiration: See Plans and Pricing

Patent: 110041
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12497
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 34687
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 011000058
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 11010854
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 11003842
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8492
Estimated Expiration: See Plans and Pricing

Patent: 1100266
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 34687
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0135803
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 09001652
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 56616
Estimated Expiration: See Plans and Pricing

Patent: 93606
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 800031
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1226
Estimated Expiration: See Plans and Pricing

Patent: 6804
Estimated Expiration: See Plans and Pricing

Japan

Patent: 25322
Estimated Expiration: See Plans and Pricing

Patent: 12500842
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 334687
Estimated Expiration: See Plans and Pricing

Patent: 2018510
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 5418
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11002166
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 285
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 590
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0943
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1027
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1100043
Estimated Expiration: See Plans and Pricing

Norway

Patent: 18019
Estimated Expiration: See Plans and Pricing

Panama

Patent: 40801
Estimated Expiration: See Plans and Pricing

Peru

Patent: 110288
Estimated Expiration: See Plans and Pricing

Poland

Patent: 34687
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 34687
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 236
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 34687
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1101341
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1338540
Estimated Expiration: See Plans and Pricing

Patent: 1446454
Estimated Expiration: See Plans and Pricing

Patent: 110045093
Estimated Expiration: See Plans and Pricing

Patent: 130116078
Estimated Expiration: See Plans and Pricing

Spain

Patent: 80408
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 87598
Estimated Expiration: See Plans and Pricing

Patent: 1014863
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 11000066
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3626
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 073
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 STEGLATRO around the world.

Country Patent Number Title Estimated Expiration
Serbia 52236 DERIVATI DIOKASA-BICIKLO (3.2.1) OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO(3.2.1)OCTANE-2,3,4-TRIOL DERIVATIVES) See Plans and Pricing
Denmark 2334687 See Plans and Pricing
Eurasian Patent Organization 018492 ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛЬНЫЕ ПРОИЗВОДНЫЕ (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010023594 See Plans and Pricing
Argentina 073138 DERIVADOS DE DIOXA-BICICLO (3.2.1) OCTANO- 2,3,4-TRIOL See Plans and Pricing
El Salvador 2011003842 DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL See Plans and Pricing
South Korea 101446454 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STEGLATRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 300943 Netherlands See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687 C02334687/01 Switzerland See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 66577 18.10.2018
2334687 132018000000441 Italy See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687 CA 2018 00025 Denmark See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323
2334687 2018/028 Ireland See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
2334687 122018000070 Germany See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687 PA2018510 Lithuania See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.