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Last Updated: April 19, 2024

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:	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	022044-002	Mar 30, 2007		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ 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			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			Y	⤷ 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 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	202270-002	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
>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
China	100430397		⤷ Try a Trial
Slovenia	1654263		⤷ Try a Trial
Japan	2006516268		⤷ 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
1532149	92128	Luxembourg	⤷ Try a Trial	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
1412357	132008901682802	Italy	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
1730131	C01730131/02	Switzerland	⤷ Try a Trial	PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.