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Generated: May 26, 2017

DrugPatentWatch Database Preview

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 three 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 fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

Summary for NDA: 022350

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022350

Mechanism of ActionDipeptidyl 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 27, 2020
Regulatory Exclusivity Use:
Patent:7,951,400Patent Expiration:Nov 30, 2028Product Flag?YSubstance Flag?Delist Request?
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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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