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Details for New Drug Application (NDA): 022350
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NDA 022350 describes ONGLYZA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ONGLYZA profile page.
The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
Summary for 022350
| Tradename: | ONGLYZA |
| Applicant: | Astrazeneca Ab |
| Ingredient: | saxagliptin hydrochloride |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022350
Generic Entry Date for 022350*:
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: 022350
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 022350
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6100 | 0310-6100-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-30) |
| ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6100 | 0310-6100-90 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-90) |
Paragraph IV (Patent) Challenges for 022350
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ONGLYZA | TABLET;ORAL | saxagliptin hydrochloride | 022350 | 2013-07-31 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Jul 31, 2009 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 5, 2019 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES | ||||||||
| Regulatory Exclusivity Expiration: | Feb 27, 2020 | ||||||||
| Regulatory Exclusivity Use: | PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN | ||||||||
| Patent: | Start Trial | Patent Expiration: | Nov 30, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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