Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

14 trials from ClinicalTrials.gov, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets NCT01975220	Phase 1	Completed	Boehringer Ingelheim	72	2013-10 → 2013-12
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills NCT03629054	Phase 1	Completed	Boehringer Ingelheim	30	2018-08-27 → 2018-11-05
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together NCT01811953	Phase 1	Completed	Boehringer Ingelheim	48	2013-03 → 2013-05
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets NCT01672788	Phase 1	Completed	Boehringer Ingelheim	36	2012-08 → 2012-11
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets NCT01844531	Phase 1	Completed	Boehringer Ingelheim	24	2013-04 → 2013-11
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood NCT03259490	Phase 1	Completed	Boehringer Ingelheim	30	2017-08-31 → 2017-11-13
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets NCT02106923	Phase 1	Completed	Boehringer Ingelheim	72	2014-04 → 2014-07
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets NCT02028767	Phase 1	Completed	Boehringer Ingelheim	32	2014-01 → 2014-02
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects NCT02230995	Phase 1	Completed	Boehringer Ingelheim	30	2014-09 → 2014-10
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets NCT02821910	Phase 1	Completed	Boehringer Ingelheim	50	2016-07-20 → 2016-10-31

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs

Highest NADAC/Unit

$5.62

per ea

Lowest NADAC/Unit

$5.60

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597015918SYNJARDY 5-500 MG TABLET	$5.62	EA	Brand	—	2026-06-17
00597015960SYNJARDY 5-500 MG TABLET	$5.62	EA	Brand	—	2026-06-17
00597016860SYNJARDY 12.5-1,000 MG TABLET	$5.60	EA	Brand	—	2026-06-17
00597016818SYNJARDY 12.5-1,000 MG TABLET	$5.60	EA	Brand	—	2026-06-17
00597018018SYNJARDY 12.5-500 MG TABLET	$5.60	EA	Brand	—	2026-06-17
00597018060SYNJARDY 12.5-500 MG TABLET	$5.60	EA	Brand	—	2026-06-17
00597017560SYNJARDY 5-1,000 MG TABLET	$5.60	EA	Brand	—	2026-06-17
00597017518SYNJARDY 5-1,000 MG TABLET	$5.60	EA	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 16 NDCs (8 FSS, 8 Big4)

Lowest Price

$313.42

Highest Price

$1306.65

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0175-18SYNJARDY 5MG/1000MG TAB	$940.25	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0175-18SYNJARDY 5MG/1000MG TAB	$940.25	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0175-60SYNJARDY 5MG/1000MG TAB	$313.42	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0175-60SYNJARDY 5MG/1000MG TAB	$313.42	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0180-18SYNJARDY 12.5MG/500MG TAB	$1306.65	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0180-18SYNJARDY 12.5MG/500MG TAB	$1306.65	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

Showing 6 of 16 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Synjardy (2024)

Total Spending

$180.2M

Total Claims

187,400

Beneficiaries

42,225

Avg Cost/Unit

$9.61

Spending Trend

$44.8M(2019)→$65.9M(2020)→$94.4M(2021)→$126.4M(2022)→$163.6M(2023)→$180.2M(2024)

YoY Change:-6.2%

5yr CAGR:+2.3%

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

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	SUPPL -46	View Letter (PDF)
Mar 11, 2025	SUPPL -45	View Letter (PDF)
Oct 31, 2023	SUPPL -42	View Letter (PDF)
Jun 21, 2023	SUPPL -38	View Letter (PDF)
Feb 7, 2023	SUPPL -33	View Letter (PDF)
Oct 14, 2022	SUPPL -36	View Letter (PDF)
Mar 22, 2022	SUPPL -31	View Letter (PDF)
Jun 28, 2021	SUPPL -25	View Letter (PDF)
Jun 15, 2021	SUPPL -26	View Letter (PDF)
Jan 27, 2020	SUPPL -22	View Letter (PDF)
Oct 30, 2018	SUPPL -18	View Letter (PDF)
Dec 15, 2017	SUPPL -15	View Letter (PDF)
Dec 27, 2016	SUPPL -4	View Letter (PDF)
Sep 22, 2016	SUPPL -6	View Letter (PDF)
Sep 22, 2016	SUPPL -9	View Letter (PDF)
Jul 12, 2016	SUPPL -1	View Letter (PDF)
Dec 7, 2015	SUPPL -2	View Letter (PDF)
Sep 2, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG;500MG

RLD

14 patents2 exclusivities▴

TABLET;ORAL | Approved: Aug 26, 2015

Patents (14) · 17 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7579449	Aug 1, 2028PED: Feb 1, 2029	PED	Yes	—	—	—
7713938	Apr 15, 2027PED: Oct 15, 2027	PED	Yes	Yes	—	—
9949997	May 17, 2034PED: Nov 17, 2034	PED	—	—		—
10258637	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
10610489	Sep 30, 2030PED: Mar 30, 2031	PED	—	Yes	—	—
11090323	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
11666590	Apr 3, 2034	—	—	—		—
11813275	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
11833166	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
12115179	Feb 11, 2030PED: Aug 11, 2030	PED	—	—		—
12263153	Apr 3, 2034	—	—	—		—
12427162	Apr 3, 2034	—	—	—		—
12433906	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
12527810	Apr 22, 2033PED: Oct 22, 2033	PED	—	—		—

Exclusivities (2)

Code	Date	Status
NPP	Jun 20, 2026	Expired
PED	Dec 20, 2026	< 1 year

#002 — 5MG;1GM

RLD

14 patents2 exclusivities▾

TABLET;ORAL | Approved: Aug 26, 2015

#003 — 12.5MG;500MG

RLD

13 patents2 exclusivities▾

TABLET;ORAL | Approved: Aug 26, 2015

#004 — 12.5MG;1GM

RLD

13 patents2 exclusivities▾

TABLET;ORAL | Approved: Aug 26, 2015