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SYNJARDY Drug Profile
When do Synjardy patents expire, and when can generic versions of Synjardy launch?
Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and thirty-seven patent family members in thirty-nine countries.
The generic ingredient in SYNJARDY 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.
Summary for SYNJARDY
| International Patents: | 137 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SYNJARDY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY |
| DailyMed Link: | SYNJARDY at DailyMed |
Recent Litigation for SYNJARDY
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 |
Pharmacology for SYNJARDY
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor Biguanide |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Synonyms for SYNJARDY
| Empagliflozin / metformin |
| Empagliflozin and metformin HCl |
| Empagliflozin and metformin hydrochloride |
| Empagliflozin mixture with metformin hydrochloride |
| Metformin / Empagliflozin |
| S900006750 |
| Synjardy XR |
US Patents and Regulatory Information for SYNJARDY
| 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 | 208658-003 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | 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 | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for SYNJARDY
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Extended-release Tablets | 5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg | ➤ Subscribe | Start Trial |
International Patents for SYNJARDY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1115133 | Start Trial |
| Germany | 602006011310 | Start Trial |
| Japan | 2007522143 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | PA2014035 | Lithuania | Start Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | C300696 | Netherlands | Start Trial | PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
