Details for New Drug Application (NDA): 021995
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NDA 021995 describes JANUVIA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three patents 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 are thirty-five drug master file entries for this compound. Three 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 are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
Summary for 021995
| Tradename: | JANUVIA |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | sitagliptin phosphate |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021995
Generic Entry Date for 021995*:
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: 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: | 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: | Aug 12, 2022 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS | ||||||||
| Regulatory Exclusivity Expiration: | Feb 12, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 021995
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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