DrugPatentWatch Database Preview
STEGLUJAN Drug Profile
Which patents cover Steglujan, and when can generic versions of Steglujan launch?
Steglujan is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are eight patents protecting this drug.
This drug has two hundred and twenty-three patent family members in fifty-three 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.
Summary for STEGLUJAN
| International Patents: | 223 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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 |
| DailyMed Link: | STEGLUJAN at DailyMed |
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.
Recent Litigation for STEGLUJAN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. | 2019-05-02 |
| Merck Sharp & Dohme Corp. v. Sandoz Inc. | 2019-02-13 |
| Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. | 2019-02-13 |
US Patents and Regulatory Information for STEGLUJAN
| 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 Pricing | See Pricing | See Pricing | ||||
| Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | RX | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | RX | Yes | No | See Pricing | See Pricing | Y | Y | See 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 | 209805-002 | Dec 19, 2017 | See Pricing | See Pricing |
| Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | See Pricing | See Pricing |
| Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | See Pricing | See Pricing |
| Merck Sharp Dohme | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-002 | Dec 19, 2017 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for STEGLUJAN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Georgia, Republic of | P20084489 | See Pricing |
| Brazil | PI0411726 | See Pricing |
| World Intellectual Property Organization (WIPO) | 2005003135 | See Pricing |
| European Patent Office | 1052994 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for STEGLUJAN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1412357 | 300287 | Netherlands | See Pricing | 300287, 20220705, EXPIRES: 20220320 |
| 2334687 | C201830047 | Spain | See Pricing | PRODUCT NAME: ERTUGLIFLOZINA, OPICIONALMENTE EN FORMA CRISTALINA, PARTICULARMENTE COMO UN CO-CRISTAL CON ACIDO L-PIROGLUTAMICO, Y ESPECIFICAMENTE COMO ACIDO L-PIROGLUTAMICO DE ERTUGLIFLOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1267; DATE OF AUTHORISATION: 20180321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1267; DATE OF FIRST AUTHORISATION IN EEA: 20180321 |
| 2334687 | 300943 | Netherlands | See Pricing | 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 |
| 1412357 | 343 | Finland | See Pricing | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
