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Last Updated: September 22, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200678


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NDA 200678 describes KOMBIGLYZE XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KOMBIGLYZE XR profile page.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 200678
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 200678
Generic Entry Date for 200678*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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: 200678
Suppliers and Packaging for NDA: 200678
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 NDA AstraZeneca Pharmaceuticals LP 0310-6125 0310-6125-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6125-60)
KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 NDA AstraZeneca Pharmaceuticals LP 0310-6125 0310-6125-92 1 BLISTER PACK in 1 CARTON (0310-6125-92) > 12 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 200678
Tradename Dosage Ingredient NDA Submissiondate
KOMBIGLYZE XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; saxagliptin hydrochloride 200678 2013-07-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;EQ 5MG BASE
Approval Date:Nov 5, 2010TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Jul 13, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Jul 13, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Jul 31, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENTWITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE

Expired US Patents for NDA 200678

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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