STEGLUJAN Drug Patent Profile
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When do Steglujan patents expire, and what generic alternatives are available?
Steglujan is a drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and thirty-eight patent family members in fifty-two countries.
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 twenty-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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Questions you can ask:
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Summary for STEGLUJAN
International Patents: | 138 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Drug Prices: | Drug price information for STEGLUJAN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STEGLUJAN |
What excipients (inactive ingredients) are in STEGLUJAN? | STEGLUJAN excipients list |
DailyMed Link: | STEGLUJAN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for STEGLUJAN
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
US Patents and Regulatory Information for STEGLUJAN
STEGLUJAN is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of STEGLUJAN is ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Expired US Patents for STEGLUJAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol de derivatives
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 10310956
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 77857
Patent: DERIVES DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 120289
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0150107
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 15949
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 96583
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 12011946
Patent: DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO- 2 ,3,4- TRIOL
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 1290267
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Georgia, Republic of
Patent: 0146104
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 96156
Estimated Expiration: ⤷ Subscribe
Patent: 13509393
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
New Zealand
Patent: 9945
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 96583
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 96583
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Slovenia
Patent: 96583
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1203486
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1426180
Estimated Expiration: ⤷ Subscribe
Patent: 120093321
Patent: DIOXA-BICYCLO [3.2.1] OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 27179
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 3416
Patent: ПОХІДНІ ДІОКСАБІЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРІОЛУ[ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (Normal;heading 1;heading 2;heading 3;DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
New Zealand | 529833 | Beta-amino tetrahydroimidazo (1, 2-A) pyrazines and tetrahydrotrioazolo (4, 3-A) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes | ⤷ Subscribe |
Panama | 8840801 | DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Subscribe |
Luxembourg | C91360 | ⤷ Subscribe | |
Norway | 2007010 | ⤷ Subscribe | |
Iceland | 2218 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STEGLUJAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2334687 | C02334687/01 | Switzerland | ⤷ Subscribe | FORMER OWNER: PFIZER INC., US |
2334687 | 18C1036 | France | ⤷ Subscribe | PRODUCT NAME: ERTUGLIFLOZINE,OPTIONNELLEMENT SOUS FORME CRISTALLINE,EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTANIQUE,ET PARTICULIEREMENT ERTUGLIFOZINE ACIDE L-PYROGLUTANIQUE.; REGISTRATION NO/DATE: EU/1/18/1267 20180323 |
1412357 | CA 2007 00040 | Denmark | ⤷ Subscribe | |
2334687 | PA2018510 | Lithuania | ⤷ Subscribe | 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 |
2334687 | 2018/028 | Ireland | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
STEGLUJAN Market Analysis and Financial Projection Experimental
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