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 |
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 |
---|---|---|---|
Hong Kong | 1094951 | 包衣片製劑和方法 (COATED TABLET FORMULATION AND METHOD) | ⤷ Try a Trial |
Japan | 4901727 | ⤷ Try a Trial | |
Croatia | P20160880 | ⤷ Try a Trial | |
Cyprus | 1117813 | ⤷ Try a Trial | |
Poland | 2298288 | ⤷ Try a Trial | |
Ukraine | 88168 | ПРЕПАРАТ В ВИДЕ ТАБЛЕТКИ САКСАГЛИПТИНА С ПОКРЫТИЕМ И СПОСОБ ЕГО ИЗГОТОВЛЕНИЯ;ПРЕПАРАТ У ВИГЛЯДІ ТАБЛЕТКИ САКСАГЛІПТИНУ З ПОКРИТТЯМ І СПОСІБ ЙОГО ВИГОТОВЛЕННЯ (COATED TABLET FORMULATION COMPRISING SAXAGLIPITIN AND METHOD FOR FORMING THEREOF) | ⤷ 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 |
---|---|---|---|---|
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 | 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 |
1506211 | SPC/GB14/050 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121 |
1412357 | C 2008 016 | Romania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
1506211 | PA2014026 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
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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