ZITUVIMET Drug Patent Profile
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Which patents cover Zituvimet, and what generic alternatives are available?
Zituvimet is a drug marketed by Zydus Lifesciences and is included in two NDAs.
The generic ingredient in ZITUVIMET is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.
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Summary for ZITUVIMET
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| What excipients (inactive ingredients) are in ZITUVIMET? | ZITUVIMET excipients list |
| DailyMed Link: | ZITUVIMET at DailyMed |
Pharmacology for ZITUVIMET
| Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
US Patents and Regulatory Information for ZITUVIMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Lifesciences | ZITUVIMET | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743-002 | Nov 3, 2023 | RX | Yes | Yes | ⤷ 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 | ||||
| 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 ZITUVIMET
| 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 |
