Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
Citi
Deloitte
US Department of Justice
Johnson and Johnson

Generated: June 27, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200678

Try a free trialSee Plans and Pricing

« Back to Dashboard

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
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;EQ 5MG BASE
Approval Date:Nov 5, 2010TE: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:➤ Sign UpPatent Expiration:Jul 13, 2025Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Farmers Insurance
Deloitte
Mallinckrodt
Medtronic
Chinese Patent Office

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.