Details for New Drug Application (NDA): 202270
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The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
Summary for 202270
Tradename: | JANUMET XR |
Applicant: | Msd Sub Merck |
Ingredient: | metformin hydrochloride; sitagliptin phosphate |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202270
Generic Entry Date for 202270*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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.
Pharmacology for NDA: 202270
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 202270
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270 | NDA | Merck Sharp & Dohme LLC | 0006-0078 | 0006-0078-28 | 2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) |
JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270 | NDA | Merck Sharp & Dohme LLC | 0006-0078 | 0006-0078-61 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG;EQ 50MG BASE | ||||
Approval Date: | Feb 2, 2012 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 4, 2023 | ||||||||
Regulatory Exclusivity Use: | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | ||||||||
Regulatory Exclusivity Expiration: | Jun 4, 2024 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 202270
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 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
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