Metformin hydrochloride; sitagliptin phosphate - Generic Drug Details
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What are the generic drug sources for metformin hydrochloride; sitagliptin phosphate and what is the scope of freedom to operate?
Metformin hydrochloride; sitagliptin phosphate
is the generic ingredient in two branded drugs marketed by Msd Sub Merck and is included in two NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Metformin hydrochloride; sitagliptin phosphate has sixty-one patent family members in forty countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for metformin hydrochloride; sitagliptin phosphate
International Patents: | 61 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 8 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for metformin hydrochloride; sitagliptin phosphate |
DailyMed Link: | metformin hydrochloride; sitagliptin phosphate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for metformin hydrochloride; sitagliptin phosphate
Generic Entry Dates for metformin hydrochloride; sitagliptin phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
Generic Entry Dates for metformin hydrochloride; sitagliptin phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for metformin hydrochloride; sitagliptin phosphate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Galenicum Health | Phase 1 |
The Affiliated Hospital of Qingdao University | Phase 1 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
See all metformin hydrochloride; sitagliptin phosphate clinical trials
Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1GM; EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 1GM; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 500MG; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for metformin hydrochloride; sitagliptin phosphate
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for metformin hydrochloride; sitagliptin phosphate
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JANUMET XR | Extended-release Tablets | metformin hydrochloride; sitagliptin phosphate | 100 mg/1000 mg | 202270 | 1 | 2012-10-22 |
JANUMET XR | Extended-release Tablets | metformin hydrochloride; sitagliptin phosphate | 50 mg/500 mg and 50 mg/1000 mg | 202270 | 1 | 2012-03-16 |
JANUMET | Tablets | metformin hydrochloride; sitagliptin phosphate | 50 mg/500 mg and 50 mg/1000 mg | 022044 | 5 | 2010-10-18 |
US Patents and Regulatory Information for metformin hydrochloride; sitagliptin phosphate
Expired US Patents for metformin hydrochloride; sitagliptin phosphate
International Patents for metformin hydrochloride; sitagliptin phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20050696 | SAL DIHIDROGENOFOSFATO DE 4-OXO-4-[3-(TRIFLUOROMETIL)-5,6-DIHIDRO[1,2,4]TRIAZOLO[4,3-a]PIRAZIN-7(8H)-IL]-1-(2,4,5-TRIFLUOROFENIL)BUTAN-2-AMINA COMO INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA IV | ⤷ Sign Up |
Argentina | 094185 | SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV | ⤷ Sign Up |
Japan | 5165582 | ⤷ Sign Up | |
Croatia | P20070534 | ⤷ Sign Up | |
Tunisia | SN05329 | PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE -IV INHIBITOR | ⤷ Sign Up |
Norway | 20060362 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for metformin hydrochloride; sitagliptin phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | CA 2008 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
1506211 | 42/2014 | Austria | ⤷ Sign Up | 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 |
1261586 | 2012C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128 |
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Sign Up | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1532149 | 92128 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
1506211 | 122014000071 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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