METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for metformin hydrochloride; saxagliptin hydrochloride and what is the scope of patent protection?
Metformin hydrochloride; saxagliptin hydrochloride
is the generic ingredient in three branded drugs marketed by Astrazeneca Ab, Dr Reddys Labs Sa, Mylan, and Sun Pharm, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Metformin hydrochloride; saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.
Three suppliers are listed for this compound.
Summary for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
International Patents: | 57 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 60 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
DailyMed Link: | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sabyasachi Sen | Phase 4 |
The First Affiliated Hospital of Guangdong Pharmaceutical University | Phase 4 |
Shenzhen Sixth People's Hospital | Phase 4 |
See all METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials
Pharmacology for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KOMBIGLYZE XR | Extended-release Tablets | metformin hydrochloride; saxagliptin hydrochloride | 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg | 200678 | 3 | 2013-07-31 |
US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Expired US Patents for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
International Patents for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1988891 | Coated tablet formulation and method | ⤷ Try a Trial |
Hong Kong | 1094951 | 包衣片製劑和方法 (COATED TABLET FORMULATION AND METHOD) | ⤷ Try a Trial |
Israel | 218117 | טבליה המכילה סאקסאגליפטין ומספר שכבות ציפוי (Tablet comprising saxagliptin and multiple coating layers) | ⤷ Try a Trial |
European Patent Office | 2298288 | Formulation de comprime revêtu et procède correspondant (Coated tablet formulation and method) | ⤷ Try a Trial |
European Patent Office | 1753406 | FORMULATION DE COMPRIME REVETU ET PROCEDE CORRESPONDANT (COATED TABLET FORMULATION AND METHOD) | ⤷ Try a Trial |
Japan | 2008501025 | ⤷ Try a Trial | |
Peru | 20060425 | FORMULACION DE TABLETA REVESTIDA QUE COMPRENDE SAXAGLIPTINA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | CA 2013 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
1506211 | 42/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
2498758 | PA2020003 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1261586 | 1290013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
1412357 | C300357 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
1506211 | 179 5017-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116 |
1261586 | C01261586/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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