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 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 are two tentative approvals for the generic drug (ertugliflozin), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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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: | 75 |
| 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 |
Recent Clinical Trials for STEGLATRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wilhelminenspital Vienna | Phase 3 |
| Klinikum Wiener Neustadt | Phase 3 |
| General Hospital Linz | Phase 3 |
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
Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
FDA Regulatory Exclusivity protecting STEGLATRO
REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803-002 | Dec 19, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803-001 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803-002 | 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 |
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
Patent: Dioxa-bicyclo[3.2.1.] octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Sign Up
Argentina
Patent: 3138
Patent: DERIVADOS DE DIOXA-BICICLO (3.2.1) OCTANO- 2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09286380
Patent: Dioxa-bicyclo(3.2.1.)octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 40040
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0918841
Patent: derivados de dioxa-biciclo[3.2.1]octano-2,3,4-triol, seus cristais e composições farmacêuticas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 33795
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: ⤷ Sign Up
Chile
Patent: 11000394
Patent: Compuestos derivados de 1-hidroximetil-6,8-dioxa-biciclo[3.2.1]octano-2,3,4-triol, inhibidores de sglt2; cocristal que comprende a dicho compuesto y l-prolina o acido l-piroglutamico; composicion farmaceutica que los comprende; utiles para el tratamiento de la obesidad y diabetes de tipo 2.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2149717
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Sign Up
Patent: 3497199
Patent: Dioxa-bicyclo[3.2.1]octane-2, 3, 4-triol derivatives
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 41636
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 110077
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120104
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 003
Patent: DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Patent: 110041
Patent: DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 12497
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 34687
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 011000058
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL UTILES PARA USAR COMO INHIBIDORES DEL TRANSPORTADOR DE SODIO-GLUCOSA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 11010854
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
El Salvador
Patent: 11003842
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8492
Patent: ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛЬНЫЕ ПРОИЗВОДНЫЕ (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Patent: 1100266
Patent: ДИОКСА-БИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛЬНЫЕ ПРОИЗВОДНЫЕ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 34687
Patent: DÉRIVÉS DE DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1036
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0135803
Patent: DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Honduras
Patent: 09001652
Patent: DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO -2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 56616
Patent: 二氧雜-雙環 辛烷- -三醇衍生物 (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES -[321]-234-)
Estimated Expiration: ⤷ Sign Up
Patent: 93606
Patent: 二氧雜-雙環 辛烷- -三醇衍生物 (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES -[321]-234-)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 800031
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1226
Patent: תולדות דיאוקסא-ביציקלו [1.2.3]אוקטאנ-4,3,2-טריאול (Dioxa -bicyclo [3.2.1]octane-2,3,4-triol derivatives)
Estimated Expiration: ⤷ Sign Up
Patent: 6804
Patent: תולדות דיאוקסא-ביציקלו[1.2.3]אוקטאנ-4,3,2-טריאול (Dioxa -bicyclo [3.2.1]octane-2,3,4-triol derivatives)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 25322
Estimated Expiration: ⤷ Sign Up
Patent: 12500842
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 334687
Estimated Expiration: ⤷ Sign Up
Patent: 2018510
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5418
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11002166
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,1-TRIOL. (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 285
Patent: DERIVATI DIOKSA-BICIKL0[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 590
Patent: مشتقات ديوكسا بيسيكلو [3. 2. 1] أوكتان-2 ،3، 4،-تريول
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 0943
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1027
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1100043
Patent: DERIVADOS DE DIOXA - BICICLO [ 3. 2. 1 ] OCTANO - 2, 3, 4 - TRIOL.
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 18019
Estimated Expiration: ⤷ Sign Up
Panama
Patent: 40801
Patent: DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 110288
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 34687
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 34687
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 236
Patent: DERIVATI DIOKASA-BICIKLO (3.2.1) OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO(3.2.1)OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 34687
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1101341
Patent: DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1338540
Estimated Expiration: ⤷ Sign Up
Patent: 1446454
Estimated Expiration: ⤷ Sign Up
Patent: 110045093
Estimated Expiration: ⤷ Sign Up
Patent: 130116078
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 80408
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 87598
Estimated Expiration: ⤷ Sign Up
Patent: 1014863
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 11000066
Patent: DERIVES DE DIOXA-BICYCLO [3.2.1]OCTANE -2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 3626
Patent: ПОХІДНІ ДІОКСАБІЦИКЛО[3,2,1]ОКТАН-2,3,4-ТРІОЛУ[ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3,2,1]ОКТАН-2,3,4-ТРИОЛА (DIOXABICYCLO[3,2,1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 073
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Montenegro | 01285 | DERIVATI DIOKSA-BICIKL0[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES) | ⤷ Sign Up |
| Argentina | 073138 | DERIVADOS DE DIOXA-BICICLO (3.2.1) OCTANO- 2,3,4-TRIOL | ⤷ Sign Up |
| France | 18C1036 | ⤷ Sign Up | |
| Panama | 8840801 | DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 | CR 2018 00025 | Denmark | ⤷ Sign Up | 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 | SPC/GB18/026 | United Kingdom | ⤷ Sign Up | 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 | 30/2018 | Austria | ⤷ Sign Up | 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 |
| >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.
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