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SYNJARDY Drug Profile
Which patents cover Synjardy, and what generic alternatives are available?
Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and eight patent family members in thirty-four countries.
The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-one 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: | 108 |
| US Patents: | 2 |
| 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 |
Pharmacology for SYNJARDY
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor Biguanide |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free 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 | Extended-release Tablets | 5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg | ➤ Subscribe | ➤ Try a Free Trial |
| ➤ Subscribe | Tablets | 5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for SYNJARDY
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Israel | 187087 | ➤ Try a Free Trial |
| Japan | 2007246544 | ➤ Try a Free Trial |
| Japan | 4181605 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014035,C1730131 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 14/055 | Ireland | ➤ Try a Free 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 |
| 90061-7 | Sweden | ➤ Try a Free Trial | PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
