Details for New Drug Application (NDA): 022044
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NDA 022044 describes JANUMET, which is a drug marketed by Msd Sub Merck and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the JANUMET profile page.
The generic ingredient in JANUMET 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 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 022044
| Tradename: | JANUMET |
| Applicant: | Msd Sub Merck |
| Ingredient: | metformin hydrochloride; sitagliptin phosphate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022044
Generic Entry Date for 022044*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 022044
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 022044
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044 | NDA | Merck Sharp & Dohme LLC | 0006-0575 | 0006-0575-03 | 2 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02) |
| JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044 | NDA | Merck Sharp & Dohme LLC | 0006-0575 | 0006-0575-56 | 4 POUCH in 1 CARTON (0006-0575-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 50MG BASE | ||||
| Approval Date: | Mar 30, 2007 | 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: | ⤷ Try a Trial | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022044
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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