DrugPatentWatch Database Preview
SYNJARDY XR Drug Profile
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Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?
This drug has one hundred and forty-three patent family members in thirty-six countries.
The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are fourteen 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: | 143 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY XR |
| DailyMed Link: | SYNJARDY XR at DailyMed |
Generic Entry Opportunity Date for SYNJARDY XR
*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.
Pharmacology for SYNJARDY XR
| Ingredient-type | Biguanides |
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor Biguanide |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
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 | 208658-001 | Dec 9, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for SYNJARDY XR
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,687,469 | Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for SYNJARDY XR
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Germany | 602006011310 | ➤ Sign Up |
| Ecuador | SP066855 | ➤ Sign Up |
| Australia | 2001239893 | ➤ Sign Up |
| Uruguay | 29505 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY XR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00696 | Netherlands | ➤ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522 |
| 14/055 | Ireland | ➤ Sign Up | 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 |
| C0074 | France | ➤ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 2014 00054 | Denmark | ➤ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
