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Last Updated: April 24, 2024

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - Generic Drug Details

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What are the generic 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:	4
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET, EXTENDED RELEASE;ORAL
Generic Entry Dates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
The Affiliated Hospital of Qingdao University	Phase 1
First Affiliated Hospital Xi'an Jiaotong University	N/A
Merck Sharp & Dohme Corp.

See all METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	1GM; EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	1GM; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	⤷ Try a Trial	⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012	⤷ Try a Trial	⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012	⤷ Try a Trial	⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012	⤷ Try a Trial	⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012	⤷ Try a Trial	⤷ Try a Trial
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	⤷ Try a Trial	⤷ Try a Trial
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

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Country	Patent Number	Title	Estimated Expiration
New Zealand	544026	Phosphoric acid salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine	⤷ Try a Trial
Hong Kong	1095144	PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR	⤷ Try a Trial
Colombia	5660266	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV	⤷ Try a Trial
South Korea	20060026061	PHOSPHORIC ACID SALT OF A DIPEPTIDYL-PEPTIDASE-IV INHIBITOR	⤷ Try a Trial
Norway	335371		⤷ Try a Trial
Costa Rica	8117	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV	⤷ Try a Trial
Dominican Republic	P2004000941	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	16/2020	Austria	⤷ Try a Trial	PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113
1506211	C01506211/02	Switzerland	⤷ Try a Trial	PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357	50/2008	Austria	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1506211	C300677	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
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
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
2498758	CR 2020 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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