Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208658

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NDA 208658 describes SYNJARDY XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SYNJARDY XR profile page.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
Summary for 208658
Pharmacology for NDA: 208658
Suppliers and Packaging for NDA: 208658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0280 0597-0280-36 1 BOTTLE in 1 CARTON (0597-0280-36) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE
SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0280 0597-0280-73 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-73)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;1GM
Approval Date:Dec 9, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 1, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 2, 2019
Regulatory Exclusivity Use:TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
Patent:  Start TrialPatent Expiration:Apr 3, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

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