Details for New Drug Application (NDA): 022044
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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: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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