EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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 ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Empagliflozin; metformin hydrochloride has two hundred and fifty patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
International Patents: | 250 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 69 |
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 |
---|---|
Novo Nordisk A/S | Phase 3 |
SINA Health Education and Welfare Trust | Phase 2/Phase 3 |
SINA Health Education and Welfare Trust | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2013010187 | COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN MERFORMINA Y UN INHIBIDOR DE DPP-4 O UN INHIBIDOR DE SGLT-2. (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR.) | ⤷ Sign Up |
Canada | 2908621 | UTILISATIONS THERAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN) | ⤷ Sign Up |
South Korea | 20150138859 | 엠파글리플로진의 치료적 용도 (THERAPEUTIC USES OF EMPAGLIFLOZIN) | ⤷ Sign Up |
New Zealand | 711661 | Therapeutic uses of empagliflozin | ⤷ Sign Up |
China | 103030617 | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture | ⤷ Sign Up |
Brazil | PI0610994 | forma cristalina de 1-cloro-4-(beta-d-glicopiranos-1-il)-2-[4-((s)-tetraidro furan-3-ilóxi)-benzil]-benzeno, composição farmacêutica, uso da referida forma cristalina e método para a fabricação da mesma | ⤷ Sign Up |
Japan | 2008208127 | GLUOCOPYRANOSYL-SUBSTITUTED PHENYL DERIVATIVE, MEDICAMENT CONTAINING THE COMPOUND, ITS USE AND PROCESS FOR PRODUCING THE SAME | ⤷ Sign Up |
>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 | C300696 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522 |
1730131 | 2014/055 | 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 |
1730131 | 568 | Finland | ⤷ Sign Up | |
1730131 | 14C0074 | France | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
1730131 | CA 2014 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522 |
1730131 | C01730131/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017 |
1730131 | 1490061-7 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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