Details for New Drug Application (NDA): 202270
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NDA 202270 describes JANUMET XR, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the JANUMET XR profile page.
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.
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: | 7,326,708*PED | 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 | 202270-003 | Feb 2, 2012 | 7,459,428 | ⤷ Subscribe |
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | 6,890,898 | ⤷ Subscribe |
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | 6,303,661 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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