STEGLUJAN Drug Patent Profile

Which patents cover Steglujan, and when can generic versions of Steglujan launch?

Steglujan is a drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this drug.

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.

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 forty-one 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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Summary for STEGLUJAN

US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLUJAN

US Patents and Regulatory Information for STEGLUJAN

STEGLUJAN is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STEGLUJAN is ⤷ Start Trial.

This potential generic entry date is based on patent 9,308,204.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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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	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No	8,080,580	⤷ Start Trial	Y	Y		⤷ Start Trial
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes	9,308,204	⤷ Start Trial	Y			⤷ Start Trial
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No	7,326,708*PED	⤷ Start Trial			Y	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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: ⤷ Start Trial

Australia

Patent: 10310956
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 77857
Estimated Expiration: ⤷ Start Trial

Costa Rica

Patent: 120289
Estimated Expiration: ⤷ Start Trial

Croatia

Patent: 0150107
Estimated Expiration: ⤷ Start Trial

Cyprus

Patent: 15949
Estimated Expiration: ⤷ Start Trial

Denmark

Patent: 96583
Estimated Expiration: ⤷ Start Trial

Ecuador

Patent: 12011946
Patent: DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO- 2 ,3,4- TRIOL
Estimated Expiration: ⤷ Start Trial

Eurasian Patent Organization

Patent: 1983
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

Patent: 1290267
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 96583
Patent: DERIVES DE DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

Georgia, Republic of

Patent: 0146104
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 96156
Estimated Expiration: ⤷ Start Trial

Patent: 13509393
Patent: ジオキサ−ビシクロ［３．２．１］オクタン−２，３，４−トリオール誘導体
Estimated Expiration: ⤷ Start Trial

Montenegro

Patent: 016
Patent: DERIVATI DIOKSABICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

New Zealand

Patent: 9945
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Start Trial

Poland

Patent: 96583
Estimated Expiration: ⤷ Start Trial

Portugal

Patent: 96583
Estimated Expiration: ⤷ Start Trial

Serbia

Patent: 827
Patent: DERIVATI DIOKSA-BICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

Slovenia

Patent: 96583
Estimated Expiration: ⤷ Start Trial

South Africa

Patent: 1203486
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 1426180
Estimated Expiration: ⤷ Start Trial

Patent: 120093321
Patent: DIOXA-BICYCLO［3.2.1］OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Start Trial

Spain

Patent: 27179
Estimated Expiration: ⤷ Start Trial

Ukraine

Patent: 3416
Patent: Normal;heading 1;heading 2;heading 3;DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Start Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Argentina	036114	TETRAHIDROIMIDAZOL[1,2-A]PIRAZINAS Y TETRAHIDROTRIAZOL[4,3-A]PIRAZINAS COMO INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA UTILES PARA EL TRATAMIENTO O LA PREVENCION DE LA DIABETES	⤷ Start Trial
Austria	321048		⤷ Start Trial
Austria	471148		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for STEGLUJAN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	300943	Netherlands	⤷ Start Trial	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	SPC/GB18/026	United Kingdom	⤷ Start Trial	PRODUCT NAME: ERTUGLIFOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFOZIN L-PYROGLUTAMIC ACID; REGISTERED: UK EU/1/18/1267/001(NI) 20180321; UK EU/1/18/1267/002(NI) 20180321; UK EU/1/18/1267/003(NI) 20180321; UK EU/1/18/1267/004(NI) 20180321; UK EU/1/18/1267/005(NI) 20180321; UK EU/1/18/1267/006(NI) 20180321; UK PLGB 53095/0064 20180321; UK PLGB 53095/0065 20180321; UK EU/1/18/1267/007(NI) 20180321; UK EU/1/18/1267/008(NI) 20180321; UK EU/1/18/1267/009(NI) 20180321; UK EU/1/18/1267/010(NI) 20180321; UK EU/1/18/1267/011(NI) 20180321; UK EU/1/18/1267/012(NI) 20180321
2334687	PA2018510	Lithuania	⤷ Start Trial	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

Indicators of Generic Entry

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Questions you can ask:

Summary for STEGLUJAN

When does loss-of-exclusivity occur for STEGLUJAN?

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