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SYNJARDY XR Drug Profile
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Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?
Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-one patent family members in forty countries.
The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Synjardy Xr
Synjardy Xr was eligible for patent challenges on August 1, 2018.
There have been fifteen 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 SYNJARDY XR
| International Patents: | 161 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SYNJARDY XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY XR |
| DailyMed Link: | SYNJARDY XR at DailyMed |
Recent Litigation for SYNJARDY XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited | 2019-08-28 |
| Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited | 2019-07-11 |
| Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited | 2018-11-08 |
Pharmacology for SYNJARDY XR
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor Biguanide |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Synonyms for SYNJARDY XR
| Empagliflozin / metformin |
| Empagliflozin and metformin HCl |
| Empagliflozin and metformin hydrochloride |
| Empagliflozin mixture with metformin hydrochloride |
| Metformin / Empagliflozin |
| S900006750 |
| Synjardy |
Paragraph IV (Patent) Challenges for SYNJARDY XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SYNJARDY XR | TABLET, EXTENDED RELEASE;ORAL | empagliflozin; metformin hydrochloride | 208658 | 2018-08-01 |
US Patents and Regulatory Information for SYNJARDY XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | 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 SYNJARDY XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | 2981271 | Start Trial |
| Germany | 102004012676 | Start Trial |
| Japan | 5147469 | Start Trial |
| Spain | 2337498 | Start Trial |
| Japan | 2017186371 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | 2014/055 | Ireland | Start Trial | PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | C 2014 039 | Romania | Start Trial | PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522 |
| 1730131 | PA2014035 | Lithuania | Start Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | 200 5026-2014 | Slovakia | Start Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
| 1730131 | C01730131/01 | Switzerland | Start Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
