Metformin / sitagliptin Extended Release Oral Tablet

Brand(s)
Janumet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-08-28)
Oldest Current Product
2012-02-02
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\METFORMIN:SITAGLIPTIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\METFORMIN HYDROCHLORIDE: SITAGLIPTIN PHOSPHATE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METFORMIN HYDROCHLORIDE: SITAGLIPTIN PHOSPHATE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METFORMIN: SITAGLIPTIN

product(s) by strength(s)

24 hr metformin hydrochloride 1000 mg / sitagliptin 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060081JanumetNDAMerck Sharp & Dohme Corp.2012-02-02METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATEORALTABLET, FILM COATED, EXTENDED RELEASENDA20227064beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50

24 hr metformin hydrochloride 1000 mg / sitagliptin 50 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060080JanumetNDAMerck Sharp & Dohme Corp.2012-02-02METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATEORALTABLET, FILM COATED, EXTENDED RELEASENDA20227064beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50

24 hr metformin hydrochloride 500 mg / sitagliptin 50 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060078JanumetNDAMerck Sharp & Dohme Corp.2012-02-02METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATEORALTABLET, FILM COATED, EXTENDED RELEASENDA20227064beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA202270JANUMET XRMERCK SHARP AND DOHME CORP2012-02-02p6635280, SUBSTANCE
p6340475, SUBSTANCE
p6890898, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE ALONE OR IN COMBINATION WITH INSULIN
p7326708, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE, SUBSTANCE
p6303661, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
p7078381, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
p7459428, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
p7125873, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE, SUBSTANCE
p6699871, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE, SUBSTANCE
NDA202270_001, NDA202270_002, NDA202270_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202270_001RXMETFORMIN HYDROCHLORIDE (500MG), SITAGLIPTIN PHOSPHATE (EQ 50MG BASE)ORALTABLET, EXTENDED RELEASEFalse2012-02-02JANUMET XR
2NDA202270_002RXSITAGLIPTIN PHOSPHATE (EQ 50MG BASE), METFORMIN HYDROCHLORIDE (1GM)ORALTABLET, EXTENDED RELEASEFalse2012-02-02JANUMET XR
3NDA202270_003RXSITAGLIPTIN PHOSPHATE (EQ 100MG BASE), METFORMIN HYDROCHLORIDE (1GM)ORALTABLET, EXTENDED RELEASETrue2012-02-02JANUMET XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6303661 (view patent)2017-04-24NDA202270, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
2p6340475 (view patent)2016-09-19NDA202270, NDA021744, NDA021748, NDA022544Ciprofloxacin Extended Release Oral Tablet
gabapentin Oral Tablet
Metformin Extended Release Oral Tablet
gabapentin Oral Capsule
3p6635280 (view patent)2016-09-19NDA202270, NDA021744, NDA021748, NDA022544Ciprofloxacin Extended Release Oral Tablet
gabapentin Oral Tablet
Metformin Extended Release Oral Tablet
gabapentin Oral Capsule
4p6699871 (view patent)2022-07-26NDA202270, NDA021995, NDA022044, NDA202343Metformin / sitagliptin Oral Tablet
sitagliptin Oral Tablet
5p6890898 (view patent)2019-02-02NDA202270, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
6p7078381 (view patent)2019-02-02NDA202270, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
7p7125873 (view patent)2022-07-26NDA202270, NDA021995, NDA022044, NDA202343Metformin / sitagliptin Oral Tablet
sitagliptin Oral Tablet
8p7326708 (view patent)2026-04-11NDA202270, NDA021995, NDA022044, NDA202343Metformin / sitagliptin Oral Tablet
sitagliptin Oral Tablet
9p7459428 (view patent)2019-02-02NDA202270, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
164beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50 (view SPL)These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET XR (sitagliptin and metformin HCl extended-release) tablets Initial U.S. Approval: 2012prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-08-2816000060078, 000060080, 000060081

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII