Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-01563	8673927	IPR	Mylan Pharmaceuticals Inc. et al.	Terminated	2016-08-10	—
IPR2016-01566	9173859	IPR	Mylan Pharmaceuticals Inc. et al.	Institution Denied	2016-08-10	—

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
Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Ltd. et al 1:2021cv01486 1 patentANDA 212331, 212335, 213654, 215072empagliflozin, empagliflozin/linagliptin, empagliflozin/metformin, empagliflozin/linagliptin/metformin	D. Del.	2021-10-22	Active	—
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Annora Pharma Private Limited et al 1:2020cv00277 1 patentANDA 212364empagliflozin/linagliptin	D. Del.	2020-02-25	Terminated 2020-11-10	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Empa/Lina FDC Food Effect Study (Japan)NCT02815644	Phase 1	Completed	Boehringer Ingelheim	22	2016-07-15 → 2016-10-05
Effects of Empagliflozin + Linagliptin vs Metformin + Insulin Glargine on Renal and Vascular Changes in Type 2 Diabetes NCT02752113	Phase 3	Completed	Institut für Pharmakologie und Präventive Medizin	101	2016-04 → 2019-05
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
Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus NCT02453555	Phase 3	Completed	Boehringer Ingelheim	275	2015-05-14 → 2017-03-27
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus NCT02489968	Phase 3	Completed	Boehringer Ingelheim	880	2015-05-12 → 2017-06-16
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
Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes NCT01734785	Phase 3	Completed	Boehringer Ingelheim	607	2013-02-08 → 2015-03-23
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
Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes NCT04131582	Phase 3	UNKNOWN	Universidad de Guanajuato	34	2019-09-01 → 2020-12-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$11.23

per ea

Lowest NADAC/Unit

$11.20

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597018230GLYXAMBI 10 MG-5 MG TABLET	$11.23	EA	Brand	—	2026-06-17
00597018239GLYXAMBI 10 MG-5 MG TABLET	$11.23	EA	Brand	—	2026-06-17
00597018290GLYXAMBI 10 MG-5 MG TABLET	$11.23	EA	Brand	—	2026-06-17
00597016430GLYXAMBI 25 MG-5 MG TABLET	$11.20	EA	Brand	—	2026-06-17
00597016439GLYXAMBI 25 MG-5 MG TABLET	$11.20	EA	Brand	—	2026-06-17
00597016490GLYXAMBI 25 MG-5 MG TABLET	$11.20	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 | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$341.21

Highest Price

$1023.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0182-30GLYXAMBI 10MG/5MG TAB	$341.21	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0182-30GLYXAMBI 10MG/5MG TAB	$341.21	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0182-39GLYXAMBI/10MG/5MG TAB	$341.21	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0182-39GLYXAMBI/10MG/5MG TAB	$341.21	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0182-90GLYXAMBI 10MG/5MG TAB	$1023.62	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0182-90GLYXAMBI 10MG/5MG TAB	$1023.62	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

Showing 6 of 12 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Glyxambi (2024)

Total Spending

$141.1M

Total Claims

136,734

Beneficiaries

28,725

Avg Cost/Unit

$19.46

Spending Trend

$54.3M(2019)→$71.5M(2020)→$91.5M(2021)→$114.2M(2022)→$136.6M(2023)→$141.1M(2024)

YoY Change:-5.8%

5yr CAGR:+1.7%

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

Approval Letters

21 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	SUPPL -44	View Letter (PDF)
Oct 31, 2023	SUPPL -36	View Letter (PDF)
Oct 14, 2022	SUPPL -33	View Letter (PDF)
Mar 22, 2022	SUPPL -31	View Letter (PDF)
Jun 28, 2021	SUPPL -27	View Letter (PDF)
Jun 15, 2021	SUPPL -30	View Letter (PDF)
Mar 31, 2020	SUPPL -21	View Letter (PDF)
Jan 27, 2020	SUPPL -23	View Letter (PDF)
Jul 5, 2019	SUPPL -17	View Letter (PDF)
Jul 2, 2019	SUPPL -22	View Letter (PDF)
Oct 30, 2018	SUPPL -19	View Letter (PDF)
Dec 15, 2017	SUPPL -12	View Letter (PDF)
Aug 15, 2017	SUPPL -11	View Letter (PDF)
Aug 15, 2017	SUPPL -13	View Letter (PDF)
Mar 20, 2017	SUPPL -8	View Letter (PDF)
Dec 27, 2016	SUPPL -7	View Letter (PDF)
Dec 27, 2016	SUPPL -9	View Letter (PDF)
Jul 11, 2016	SUPPL -6	View Letter (PDF)
Dec 7, 2015	SUPPL -3	View Letter (PDF)
Sep 1, 2015	SUPPL -1	View Letter (PDF)
Feb 3, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG;5MG

RLD

15 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 30, 2015

Patents (15) · 15 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	—	—
8551957	Oct 14, 2029PED: Apr 14, 2030	PED	—	Yes		—
8673927	May 4, 2027PED: Nov 4, 2027	PED	—	—		Delisted
8883805	Nov 26, 2025PED: May 26, 2026	PED	—	Yes	—	—
9173859	May 4, 2027	—	—	Yes		Delisted
9949998	Jun 11, 2034	—	—	—		—
10258637	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
11033552	May 4, 2027PED: Nov 4, 2027	PED	—	Yes	—	—
11090323	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
11833166	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—
12115179	Feb 11, 2030PED: Aug 11, 2030	PED	—	—		—
12178819	May 4, 2027	—	—	Yes	—	—
12364700	Jun 8, 2037PED: Dec 8, 2037	PED	—	—		—
12433906	Apr 3, 2034PED: Oct 3, 2034	PED	—	—		—

#002 — 25MG;5MG

RLD

15 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 30, 2015