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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

ANDA

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | A211563 | ALKEM LABORATORIES LTD

4 strengths0 unique patents1 unique exclusivity

Reference Listed Drug: XIGDUO XR(TE code: AB)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

Oct. 3, 2026

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2026	ORIG -1	View Letter (PDF)
Jun 9, 2026	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG;500MG

0 patents1 exclusivity▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

Exclusivities (1)

Code	Date	Status
PC	Oct 3, 2026	< 1 year

#002 — 5MG;1GM

0 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

#003 — 10MG;500MG

0 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

#004 — 10MG;1GM

0 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

Change History (4)

Recent changes detected for this application.

ADDED7/1/2026

New: New record

ADDED7/1/2026

New: New record

ADDED7/1/2026

New: New record

ADDED7/1/2026

Alkem Labs' dapagliflozin and metformin hydrochloride combination (NDA 211563, Supplement 004) acquired pediatric exclusivity as of this record addition.

New: New record