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NDA

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | N210874 | ASTRAZENECA AB

4 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expired (1)Expiring < 1yr (1)Active (3)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

Today

Apr. 4, 2026

Jun. 16, 2030

Dec. 20, 2027

Sep. 21, 2028

May. 12, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 27, 2020	SUPPL -3	View Letter (PDF)
Jul 2, 2019	SUPPL -1	View Letter (PDF)
May 3, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2.5MG;1GM;EQ 2.5MG BASE

RLD

5 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 2, 2019

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
6515117	Oct 4, 2025PED: Apr 4, 2026	PED	Yes	Yes		—
7919598	Dec 16, 2029PED: Jun 16, 2030	PED	Yes	—	—	—
8501698	Jun 20, 2027PED: Dec 20, 2027	PED	—	Yes		—
8716251	Mar 21, 2028PED: Sep 21, 2028	PED	—	Yes	—	—
9616028	Nov 12, 2030PED: May 12, 2031	PED	—	Yes	—	—

#002 — 5MG;1GM;EQ 2.5MG BASE

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 2, 2019

#003 — 5MG;1GM;EQ 5MG BASE

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 2, 2019

#004 — 10MG;1GM;EQ 5MG BASE

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 2, 2019