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 three branded drugs marketed by Zydus Lifesciences and Msd Sub Merck, and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for METFORMIN HYDROCHLORIDE; SITAGLIPTIN
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 189 |
DailyMed Link: | METFORMIN HYDROCHLORIDE; SITAGLIPTIN at DailyMed |
Recent Clinical Trials for METFORMIN HYDROCHLORIDE; SITAGLIPTIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Institute of Liver and Biliary Sciences, India | N/A |
University Health Network, Toronto | Phase 4 |
Peking University People's Hospital | Phase 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 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
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | 022044-001 | Mar 30, 2007 | RX | Yes | No | ⤷ 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 | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743-001 | Nov 3, 2023 | RX | Yes | No | ⤷ 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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