STEGLUJAN Drug Patent Profile
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Which patents cover Steglujan, and what generic alternatives are available?
Steglujan is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are five patents protecting this drug.
This drug has two hundred and ten patent family members in fifty-four 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 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
Summary for STEGLUJAN
International Patents: | 210 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
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 Generic Entry Opportunity 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.
Anatomical Therapeutic Chemical (ATC) Classes for STEGLUJAN
US Patents and Regulatory Information for STEGLUJAN
STEGLUJAN is protected by five US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of STEGLUJAN 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 STEGLUJAN
Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 STEGLUJAN
NEW CHEMICAL ENTITY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | 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 |
Expired US Patents for STEGLUJAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | See Plans and Pricing | See Plans and Pricing |
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | See Plans and Pricing | See Plans and Pricing |
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | See Plans and Pricing | See Plans and Pricing |
Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | See Plans and Pricing | See Plans and Pricing |
>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
Estimated Expiration: See Plans and Pricing
Australia
Patent: 10310956
Estimated Expiration: See Plans and Pricing
Canada
Patent: 77857
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 120289
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0150107
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 15949
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 96583
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 12011946
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 1983
Estimated Expiration: See Plans and Pricing
Patent: 1290267
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 96583
Estimated Expiration: See Plans and Pricing
Japan
Patent: 96156
Estimated Expiration: See Plans and Pricing
Patent: 13509393
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 016
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 9945
Estimated Expiration: See Plans and Pricing
Poland
Patent: 96583
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 96583
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 827
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 96583
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1203486
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1426180
Estimated Expiration: See Plans and Pricing
Patent: 120093321
Estimated Expiration: See Plans and Pricing
Spain
Patent: 27179
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 3416
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 STEGLUJAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Georgia, Republic of | P20135803 | DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES | See Plans and Pricing |
Ecuador | SP044935 | INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA BETA-AMINO HETEROCÍCLICA PARA EL TRATAMIENTO O LA PREVENCIÓN DE LA DIABETES | See Plans and Pricing |
Japan | 2006516268 | See Plans and Pricing | |
Eurasian Patent Organization | 200501805 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STEGLUJAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | 50/2008 | Austria | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408 |
1412357 | 106 4-2007 | Slovakia | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321 |
1412357 | 42/2007 | Austria | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323 |
1412357 | CA 2008 00035 | Denmark | See Plans and Pricing | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |