Empagliflozin; metformin hydrochloride - Generic Drug Details
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What are the generic sources for empagliflozin; metformin hydrochloride and what is the scope of patent protection?
Empagliflozin; metformin hydrochloride
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Empagliflozin; metformin hydrochloride has three hundred and ninety-four patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for empagliflozin; metformin hydrochloride
| International Patents: | 394 |
| US Patents: | 15 |
| Tradenames: | 3 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 93 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for empagliflozin; metformin hydrochloride |
| DailyMed Link: | empagliflozin; metformin hydrochloride at DailyMed |
Recent Clinical Trials for empagliflozin; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chong Kun Dang Pharmaceutical | PHASE4 |
| Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | PHASE1 |
| Erbil Polytechnic University | PHASE4 |
See all empagliflozin; metformin hydrochloride clinical trials
Pharmacology for empagliflozin; metformin hydrochloride
| Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for empagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SYNJARDY | Tablets | empagliflozin; metformin hydrochloride | 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg | 206111 | 4 | 2018-08-01 |
| SYNJARDY XR | Extended-release Tablets | empagliflozin; metformin hydrochloride | 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg | 208658 | 3 | 2018-08-01 |
US Patents and Regulatory Information for empagliflozin; metformin hydrochloride
Expired US Patents for empagliflozin; metformin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for empagliflozin; metformin hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 104906582 | ⤷ Start Trial | |
| Hong Kong | 1188776 | 吡喃葡萄糖基取代的苯基衍生物、含該化合物的藥物、其用途及其製造方法 (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF) | ⤷ Start Trial |
| South Korea | 20080015424 | CRYSTALLINE FORM OF 1-CHLORO-4-(beta;-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS | ⤷ Start Trial |
| Japan | 7161405 | ⤷ Start Trial | |
| South Africa | 200705883 | Crystalline form of 1-chloro-4-(B-D-glucopyranos-1-yl)-2-[4((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments | ⤷ Start Trial |
| New Zealand | 711661 | Therapeutic uses of empagliflozin | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for empagliflozin; metformin hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | C01730131/04 | Switzerland | ⤷ Start Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021 |
| 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 | C20140033 00134 | Estonia | ⤷ Start Trial | PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014 |
| 1730131 | 62/2014 | Austria | ⤷ Start Trial | PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527 |
| 1730131 | C01730131/02 | Switzerland | ⤷ Start Trial | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
| 1730131 | PA2014035,C1730131 | Lithuania | ⤷ Start Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Empagliflozin and Metformin Hydrochloride
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