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Last Updated: November 2, 2024

Metformin hydrochloride; sitagliptin - Generic Drug Details


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What are the generic sources for metformin hydrochloride; sitagliptin and what is the scope of patent protection?

Metformin hydrochloride; sitagliptin is the generic ingredient in four branded drugs marketed by Zydus Lifesciences and Msd Sub Merck, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for metformin hydrochloride; sitagliptin
Recent Clinical Trials for metformin hydrochloride; sitagliptin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Institute of Liver and Biliary Sciences, IndiaN/A
University Health Network, TorontoPhase 4
Jiangsu Province Geriatric InstitutePhase 4

See all metformin hydrochloride; sitagliptin clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up500MG; EQ 50MG BASETABLET, 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

US Patents and Regulatory Information for metformin hydrochloride; sitagliptin

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences ZITUVIMET XR metformin hydrochloride; sitagliptin TABLET, EXTENDED RELEASE;ORAL 216778-003 Jul 18, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for metformin hydrochloride; sitagliptin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Ristfor sitagliptin, metformin hydrochloride EMEA/H/C/001235
For patients with type-2 diabetes mellitus:Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Authorised no no no 2010-03-15
Accord Healthcare S.L.U. Sitagliptin / Metformin hydrochloride Accord sitagliptin, metformin hydrochloride EMEA/H/C/005850
For adult patients with type 2 diabetes mellitus:It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Authorised yes no no 2022-07-22
Sun Pharmaceutical Industries Europe B.V. Sitagliptin / Metformin hydrochloride Sun sitagliptin, metformin hydrochloride EMEA/H/C/005778
For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Authorised yes no no 2023-03-31
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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