Details for New Drug Application (NDA): 021995
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NDA 021995 describes JANUVIA, which is a drug marketed by MSD and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the JANUVIA profile page.
The generic ingredient in JANUVIA is sitagliptin phosphate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
The generic ingredient in JANUVIA is sitagliptin phosphate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
Summary for 021995
| Tradename: | JANUVIA |
| Applicant: | Msd |
| Ingredient: | sitagliptin phosphate |
| Patents: | 1 |
Pharmacology for NDA: 021995
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for 021995
Suppliers and Packaging for NDA: 021995
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995 | NDA | Merck Sharp & Dohme LLC | 0006-0112 | 0006-0112-28 | 100 BLISTER PACK in 1 CARTON (0006-0112-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01) |
| JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995 | NDA | Merck Sharp & Dohme LLC | 0006-0112 | 0006-0112-31 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Oct 16, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,326,708*PED | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Oct 16, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,326,708*PED | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Oct 16, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,326,708*PED | Patent Expiration: | May 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021995
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | 6,303,661 | ⤷ Start Trial |
| Msd | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | 7,459,428 | ⤷ Start Trial |
| Msd | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | 6,303,661 | ⤷ Start Trial |
| Msd | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | 7,078,381 | ⤷ Start Trial |
| Msd | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | 7,459,428 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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