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 nine 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

Tradename:	SYNJARDY XR
Applicant:	Boehringer Ingelheim
Ingredient:	empagliflozin; metformin hydrochloride
Patents:	9

Pharmacology for NDA: 208658

Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;1GM
Approval Date:	Dec 9, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 20, 2026
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Jun 20, 2026
Regulatory Exclusivity Use:	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
Patent:	⤷ Sign Up	Patent Expiration:	Oct 3, 2034	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 208658

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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