STEGLATRO Drug Patent Profile

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 sixty patent family members in forty-nine countries.

The generic ingredient in STEGLATRO is ertugliflozin. Two suppliers are 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.

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.

There is one tentative approval for the generic drug (ertugliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for STEGLATRO

International Patents:	60
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	4
Patent Applications:	76
Drug Prices:	Drug price information for STEGLATRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLATRO
What excipients (inactive ingredients) are in STEGLATRO?	STEGLATRO excipients list
DailyMed Link:	STEGLATRO at DailyMed

See drug prices for STEGLATRO

Recent Clinical Trials for STEGLATRO

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

Sponsor	Phase
Elisabethinen Hospital	Phase 3
Medical University of Graz	Phase 3
Medical University Innsbruck	Phase 3

See all STEGLATRO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for STEGLATRO

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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 one FDA Regulatory Exclusivity.

Patents protecting STEGLATRO

FDA Regulatory Exclusivity protecting STEGLATRO

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			Y	Y
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-001	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes			Y	Y

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

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)

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Morocco	32590	مشتقات ديوكسا بيسيكلو [3. 2. 1] أوكتان-2 ،3، 4،-تريول
Spain	2380408
Eurasian Patent Organization	201100266	ДИОКСА-БИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛЬНЫЕ ПРОИЗВОДНЫЕ
China	102149717	Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Brazil	PI0918841	derivados de dioxa-biciclo[3.2.1]octano-2,3,4-triol, seus cristais e composições farmacêuticas
Israel	236804	תולדות דיאוקסא-ביציקלו[1.2.3]אוקטאנ-4,3,2-טריאול (Dioxa -bicyclo [3.2.1]octane-2,3,4-triol derivatives)
New Zealand	591027	DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES

Supplementary Protection Certificates for STEGLATRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687	30/2018	Austria		PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323
2334687	2018/028	Ireland		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	300943	Netherlands		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	716	Finland
2334687	392 18-2018	Slovakia		PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323