Viewing data from:

XIGDUO XR

NDA

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | N205649 | ASTRAZENECA AB

5 strengths5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

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

2026

2027

2028

2029

2030

2031

Today

Apr. 4, 2026

Jun. 16, 2030

Dec. 20, 2027

Nov. 26, 2030

May. 12, 2031

NPP

Dec. 12, 2027

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

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB v. Apotex Inc. et al 1:2024cv00551	D. Del.	2024-05-06	Terminated 2025-07-29	—
AstraZeneca AB v. Sun Pharmaceutical Industries Limited et al 1:2023cv01381 1 patentANDA 211491dapagliflozin/metformin hydrochloride	D. Del.	2023-12-04	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects NCT03138356	Phase 1	Completed	AstraZeneca	126	2017-05-25 → 2017-11-28
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions NCT03216278	Phase 1	Completed	AstraZeneca	284	2017-09-26 → 2018-05-22
Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers NCT01156246	Phase 1	Completed	AstraZeneca	18	2010-06 → 2010-08
Drug Interaction With Metformin NCT00546741	Phase 1	Completed	AstraZeneca	18	2007-11 → 2008-02
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.NCT03169959	Phase 1	Completed	AstraZeneca	85	2017-05-29 → 2017-08-03
Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy NCT03700801	Phase 4	Completed	Zhujiang Hospital	130	2018-10-01 → 2019-12-20
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects NCT02637037	Phase 1	Completed	AstraZeneca	80	2015-12-21 → 2016-04-07
Effectiveness of Dapagliflozin for Weight Loss NCT03968224	Phase 2/3	Completed	Centro Medico Nacional Siglo XXI IMSS	160	2018-08-04 → 2024-07-31
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets NCT01055691	Phase 1	Completed	AstraZeneca	120	2010-01 → 2010-04
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately NCT01535677	Phase 1	Completed	AstraZeneca	71	2013-04 → 2013-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 7 NDCs (5 brand, 2 generic)

Highest NADAC/Unit

$19.22

per ea

Lowest NADAC/Unit

$0.4755

per ea

Brand NDCs

Generic NDCs

Avg Brand: $15.36

Avg Generic: $0.6233

96% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00310627030XIGDUO XR 10 MG-500 MG TABLET	$19.22	EA	Brand	—	2026-06-17
00310628030XIGDUO XR 10 MG-1,000 MG TAB	$19.20	EA	Brand	$0.7711	2026-06-17
00310625030XIGDUO XR 5 MG-500 MG TABLET	$19.17	EA	Brand	—	2026-06-17
00310622560XIGDUO XR 2.5 MG-1,000 MG TAB	$9.60	EA	Brand	—	2026-06-17
00310626060XIGDUO XR 5 MG-1,000 MG TABLET	$9.59	EA	Brand	$0.4755	2026-06-17
66993036230DAPAGLIFLOZIN-METFORMIN ER 10-1,000 MG TABLET	$0.7711	EA	Generic	—	2026-07-15
66993036160DAPAGLIFLOZIN-METFORMIN ER 5-1,000 MG TABLET	$0.4755	EA	Generic	—	2026-07-15

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$239.95

Highest Price

$536.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-6225-60XIGDUO XR 2.5MG/1000MG TAB	$536.14	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-6225-60XIGDUO XR 2.5MG/1000MG TAB	$446.13	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-6250-30XIGDUO XR 5MG/500MG	$477.24	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-6250-30XIGDUO XR 5MG/500MG	$445.48	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-6260-60XIGDUO XR 5MG/1000MG	$477.24	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-6260-60XIGDUO XR 5MG/1000MG	$445.28	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

Showing 6 of 14 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Xigduo XR (2024)

Total Spending

$203.5M

Total Claims

215,012

Beneficiaries

46,616

Avg Cost/Unit

$13.61

Spending Trend

$52.8M(2019)→$73.9M(2020)→$114.2M(2021)→$153.8M(2022)→$198.9M(2023)→$203.5M(2024)

YoY Change:-4.6%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Dec 26, 2024	SUPPL -23	View Letter (PDF)
Jun 13, 2024	SUPPL -22	View Letter (PDF)
Sep 13, 2023	SUPPL -21	View Letter (PDF)
Oct 14, 2022	SUPPL -18	View Letter (PDF)
Apr 12, 2022	SUPPL -17	View Letter (PDF)
Feb 4, 2022	SUPPL -16	View Letter (PDF)
Feb 4, 2020	SUPPL -14	View Letter (PDF)
Jan 27, 2020	SUPPL -12	View Letter (PDF)
Jan 27, 2020	SUPPL -13	View Letter (PDF)
Oct 22, 2019	SUPPL -11	View Letter (PDF)
Feb 27, 2019	SUPPL -9	View Letter (PDF)
Oct 29, 2018	SUPPL -10	View Letter (PDF)
Mar 3, 2017	SUPPL -6	View Letter (PDF)
Aug 17, 2016	SUPPL -5	View Letter (PDF)
Jun 16, 2016	SUPPL -4	View Letter (PDF)
Dec 7, 2015	SUPPL -3	View Letter (PDF)
Oct 31, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 5MG;500MG

RLDAB

5 patents2 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 29, 2014

Patents (5) · 3 use codes

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		—
8685934	May 26, 2030PED: Nov 26, 2030	PED	—	—		—
9616028	Nov 12, 2030PED: May 12, 2031	PED	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NPP	Jun 12, 2027	< 1 year
PED	Dec 12, 2027	Active

#002 — 5MG;1GM

RLDAB

5 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 29, 2014

#003 — 10MG;500MG

RLDAB

5 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 29, 2014

#004 — 10MG;1GM

RLDAB

5 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 29, 2014

#005 — 2.5MG;1GM

RLDAB

5 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 28, 2017