Viewing data from:

JENTADUETO XR

NDA

LINAGLIPTIN; METFORMIN HYDROCHLORIDE | N208026 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

2 strengths9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents (2 delisted), 1 exclusivity by expiration date

Expired (1)Expiring < 1yr (2)Active (6)TodayPED (+6 mo)ExclusivityIPRPTAB ChallengeDelisted

2 patents delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

May. 26, 2026

Nov. 21, 2030

Oct. 2, 2029

Sep. 6, 2033

Oct. 2, 2029

Apr. 10, 2030

Dec. 8, 2037

Nov. 4, 2027DelistedIPR

9173859

Nov. 4, 2027DelistedIPR

M-295

Dec. 20, 2026

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

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

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

21 trials from ClinicalTrials.gov, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers NCT02221414	Phase 1	Completed	Boehringer Ingelheim	95	2010-01
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet NCT01383356	Phase 1	Completed	Boehringer Ingelheim	58	2011-06 → 2011-12
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
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin NCT01540487	Phase 1	Completed	Boehringer Ingelheim	48	2012-02 → 2012-06
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets NCT01845077	Phase 1	Completed	Boehringer Ingelheim	72	2013-05 → 2013-08
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine NCT04088461	Phase 4	Completed	Universidad de Guanajuato	31	2016-09 → 2018-09
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
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects NCT02121509	Phase 1	Completed	Boehringer Ingelheim	74	2014-05 → 2014-07
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid NCT00915772	Phase 3	Completed	Boehringer Ingelheim	567	2009-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$16.95

per ea

Lowest NADAC/Unit

$8.46

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597027533JENTADUETO XR 5 MG-1,000 MG TB	$16.95	EA	Brand	—	2026-06-17
00597027581JENTADUETO XR 5 MG-1,000 MG TB	$16.95	EA	Brand	—	2026-06-17
00597027073JENTADUETO XR 2.5 MG-1,000 MG	$8.46	EA	Brand	—	2026-06-17
00597027094JENTADUETO XR 2.5 MG-1,000 MG	$8.46	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$392.65

Highest Price

$1424.84

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0270-73JENTADUETO XR 2.5MG/1000MG TAB	$474.94	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0270-73JENTADUETO XR 2.5MG/1000MG TAB	$392.83	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0270-94JENTADUETO XR 2.5MG/1000MG TAB	$1424.84	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0270-94JENTADUETO XR 2.5MG/1000MG TAB	$1177.62	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0275-33JENTADUETO XR 5MG/1000MG TAB	$474.94	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0275-33JENTADUETO XR 5MG/1000MG TAB	$392.65	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0275-81JENTADUETO XR 5MG/1000MG TAB	$1424.84	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0275-81JENTADUETO XR 5MG/1000MG TAB	$1177.80	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Jentadueto XR (2024)

Total Spending

$31.0M

Total Claims

38,263

Beneficiaries

7,975

Avg Cost/Unit

$12.51

Spending Trend

$18.3M(2019)→$23.7M(2020)→$26.6M(2021)→$28.8M(2022)→$29.9M(2023)→$31.0M(2024)

YoY Change:-6.4%

5yr CAGR:+2.4%

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jun 21, 2023	SUPPL -24	View Letter (PDF)
Oct 5, 2021	SUPPL -20	View Letter (PDF)
Mar 31, 2020	SUPPL -12	View Letter (PDF)
Jul 5, 2019	SUPPL -8	View Letter (PDF)
Jul 2, 2019	SUPPL -13	View Letter (PDF)
Aug 15, 2017	SUPPL -5	View Letter (PDF)
Mar 20, 2017	SUPPL -3	View Letter (PDF)
Dec 27, 2016	SUPPL -4	View Letter (PDF)
Jun 1, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG;1GM

RLD

9 patents2 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 27, 2016

Patents (9) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8673927	May 4, 2027PED: Nov 4, 2027	PED	—	—		Delisted
8883805	Nov 26, 2025PED: May 26, 2026	PED	—	Yes	—	—
9155705	May 21, 2030PED: Nov 21, 2030	PED	—	Yes	—	—
9173859	May 4, 2027PED: Nov 4, 2027	PED	—	Yes		Delisted
9415016	Apr 2, 2029PED: Oct 2, 2029	PED	—	Yes	—	—
9555001	Mar 6, 2033PED: Sep 6, 2033	PED	—	Yes		—
10022379	Apr 2, 2029PED: Oct 2, 2029	PED	—	—		—
11911388	Apr 10, 2030	—	—	—		—
12364700	Jun 8, 2037PED: Dec 8, 2037	PED	—	—		—

Exclusivities (2)

Code	Date	Status
M-295	Jun 20, 2026	Expired
PED	Dec 20, 2026	< 1 year

#002 — 5MG;1GM

RLD

9 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 27, 2016