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Last Updated: May 20, 2022

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.
Summary for 022350
Tradename:ONGLYZA
Applicant:Astrazeneca Ab
Ingredient:saxagliptin hydrochloride
Patents:2
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated 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
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 2009TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Nov 30, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jul 31, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
Patent:See Plans and PricingPatent Expiration:Jul 31, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN ALONE OR IN COMBINATION WITH INSULIN, METFORMIN, A THIAZOLIDINEDIONE, GLYBURIDE OR METFORMIN PLUS A SULFONYLUREA

Expired US Patents for NDA 022350

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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