Metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details
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What are the generic drug sources for metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?
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 |
Dongguan Kanghua Hospital | Phase 4 |
Third Affiliated Hospital, Sun Yat-Sen University | 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 |
---|---|---|---|
Portugal | 2298288 | ⤷ Try a Trial | |
Hungary | E029446 | ⤷ Try a Trial | |
Lithuania | 2298288 | ⤷ Try a Trial | |
China | 102895208 | Coated tablet formulation and method | ⤷ Try a Trial |
Canada | 2568391 | FORMULATION DE COMPRIME REVETU ET PROCEDE CORRESPONDANT (COATED TABLET FORMULATION AND METHOD) | ⤷ Try a Trial |
Taiwan | 200609002 | Coated tablet formulation and method | ⤷ 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 |
---|---|---|---|---|
2498758 | 301040 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113 |
1506211 | 300677 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
2498758 | 2090013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
1532149 | PA2012022 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
1532149 | C300569 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720 |
1261586 | 12C0028 | France | ⤷ Try a Trial | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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