Orange Book product · Brand (NDA)

XIGDUO XR

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand (NDA)NDA 205649TE ABRX ASTRAZENECA AB

Jul 28, 2017

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 28, 2017
9 yr ago
Patent 6515117 expires
Listed drug substance patent expiration.
Oct 04, 2025
9 mo ago
Patent 6515117*PED expires
Listed listed patent expiration.
Apr 04, 2026
3 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
Patent 8501698 expires
Listed drug product patent expiration.
Jun 20, 2027
in 1 yr
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
Patent 8501698*PED expires
Listed listed patent expiration.
Dec 20, 2027
in 1 yr 6 mo
Patent 7919598 expires
Listed drug substance patent expiration.
Dec 16, 2029
in 3 yr 7 mo
Patent 8685934 expires
Listed method-of-use patent (U-1522) expiration.
May 26, 2030
in 4 yr
Patent 7919598*PED expires
Listed listed patent expiration.
Jun 16, 2030
in 4 yr 1 mo
Patent 9616028 expires
Listed drug product patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 8685934*PED expires
Listed listed patent expiration.
Nov 26, 2030
in 4 yr 6 mo
Patent 9616028*PED expires
Listed listed patent expiration.
May 12, 2031
in 5 yr

Active ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Strength

2.5MG;1GM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 205649

Product number

005

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6515117	Oct 04, 2025	9 mo ago	SubstanceProductU-493
6515117*PED	Apr 04, 2026	3 mo ago
8501698	Jun 20, 2027	in 1 yr	ProductU-493
8501698*PED	Dec 20, 2027	in 1 yr 6 mo
7919598	Dec 16, 2029	in 3 yr 7 mo	Substance
8685934	May 26, 2030	in 4 yr	U-1522
7919598*PED	Jun 16, 2030	in 4 yr 1 mo
9616028	Nov 12, 2030	in 4 yr 6 mo	Product
8685934*PED	Nov 26, 2030	in 4 yr 6 mo
9616028*PED	May 12, 2031	in 5 yr