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Last Updated: July 5, 2020

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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)
Paragraph IV (Patent) Challenges for 208658
Tradename Dosage Ingredient NDA Submissiondate
SYNJARDY XR TABLET, EXTENDED RELEASE;ORAL empagliflozin; metformin hydrochloride 208658 2018-08-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;1GM
Approval Date:Dec 9, 2016TE:RLD:Yes
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
Patent:  Start TrialPatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 5, 2025Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 208658

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016   Start Trial   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016   Start Trial   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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