DrugPatentWatch Database Preview
SYNJARDY XR Drug Profile
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 fifty-six patent family members in thirty-nine 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.
Summary for SYNJARDY XR
| International Patents: | 156 |
| 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 |
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 | See Pricing | See Pricing | See Pricing | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | RX | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | See Pricing | See Pricing | Y | See Pricing | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | RX | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| >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 XR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg | ➤ Subscribe | See Pricing |
International Patents for SYNJARDY XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2360165 | See Pricing |
| Serbia | 58097 | See Pricing |
| New Zealand | 563563 | See Pricing |
| Malaysia | 151336 | See Pricing |
| Canada | 2812519 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | PA2014035 | Lithuania | See Pricing | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | C01730131/01 | Switzerland | See Pricing | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014 |
| 2187879 | 2017/018 | Ireland | See Pricing | PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111 |
| 1730131 | 568 | Finland | See Pricing | |
| 1730131 | PA2014035,C1730131 | Lithuania | See Pricing | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
