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TRADJENTA

NDA

LINAGLIPTIN | N201280 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength10 unique patents2 unique exclusivities

Patent Timeline

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

Expired (1)Expiring < 1yr (3)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

Sep. 5, 2031IPR

May. 26, 2026

Feb. 5, 2030

Feb. 5, 2030

Nov. 4, 2027

Apr. 10, 2030

May. 4, 2027

Dec. 8, 2037

Nov. 4, 2027DelistedIPR

8846695

Dec. 4, 2030DelistedIPR

M-295

Dec. 20, 2026

PTAB Proceedings

4 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	—
IPR2016-01564	8846695	IPR	Mylan Pharmaceuticals Inc. et al.	Terminated	2016-08-10	—
IPR2016-01565	8853156	IPR	Mylan Pharmaceuticals Inc. et al.	Terminated	2016-08-10	—
IPR2016-01566	9173859Delisted	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

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Ipca Laboratories Ltd. 1:2026cv00336 3 patentsANDA 220564linagliptin	D. Del.	2026-03-26	Terminated 2026-06-10	—
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Biocon Limited et al 1:2025cv00523 4 patentsANDA 220117linagliptin	D. Del.	2025-04-30	Terminated 2025-10-28	—
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2024cv00082 1 patentANDA 208431, 208430linagliptin	WVND	2024-08-29	Terminated 2025-11-24	—
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD et al 3:2016cv01727 1 patentANDA 208455, 208454linagliptin; linagliptin and metformin hydrochloride	D.N.J.	2016-03-29	Terminated 2016-04-19	—
Boehringer Ingelheim Pharmaceuticals, Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2015cv00145 3 patentsANDA 208431, 208430linagliptin	WVND	2015-08-25	Terminated 2016-07-27	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tradjenta (2023)

Total Spending

$1.3B

Total Claims

1,496,546

Beneficiaries

286,808

Avg Cost/Unit

$18.04

Spending Trend

$1.2B(2019)→$1.3B(2020)→$1.3B(2021)→$1.3B(2022)→$1.3B(2023)

YoY Change:+4.1%

5yr CAGR:+5.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain34 active DMFs1 inactive

30 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDLINAGLIPTIN

DMF 279072014

MSN PHARMACHEM PRIVATE LTDLINAGLIPTIN [ROUTE CODE "LG"]

DMF 280982014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDLINAGLIPTIN

DMF 284042014

MATRIX PHARMACORP PRIVATE LTDLINAGLIPTIN

DMF 287482014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLINAGLIPTIN

DMF 287662014

DR REDDYS LABORATORIES LTDLINAGLIPTIN

DMF 287672015

TAPI NL BVLINAGLIPTIN

DMF 287692014

HONOUR LAB LTDLINAGLIPTIN

DMF 288772015

HONOUR LAB LTDLINAGLIPTIN PREMIX

DMF 288782015

APITORIA PHARMA PRIVATE LTDLINAGLIPTIN

DMF 289402015

SUN PHARMACEUTICAL INDUSTRIES LTDLINAGLIPTIN

DMF 289712015

ZYDUS LIFESCIENCES LTDLINAGLIPTIN AMORPHOUS

DMF 290172015

ZAKLADY FARMACEUTYCZNE POLPHARMA SALINAGLIPTIN

DMF 298442015

WISDOM PHARMACEUTICAL CO LTDLINAGLIPTIN

DMF 312942016

ALEMBIC PHARMACEUTICALS LTDLINAGLIPTIN

DMF 314522017

SHANGHAI WONDER PHARMACEUTICAL CO LTDLINAGLIPTIN

DMF 323862018

MACLEODS PHARMACEUTICALS LTDLINAGLIPTIN

DMF 324982018

FUXIN LONG RUI PHARMACEUTICAL CO LTDLINAGLIPTIN

DMF 330982018

MOREPEN LABORATORIES LTDLINAGLIPTIN

DMF 341622019

CHIERON ACTIVE INGREDIENTS PRIVATE LTDLINAGLIPTIN

DMF 357482021

BIOCON LTDLINAGLIPTIN

DMF 357712021

MOREPEN LABORATORIES LTDLINAGLIPTIN FORM C

DMF 360132021

OPTIMUS DRUGS PRIVATE LTDLINAGLIPTIN

DMF 366502022

LEE PHARMA LTDLINAGLIPTIN

DMF 369232023

CENTAUR PHARMACEUTICALS PVT LTDLINAGLIPTIN

DMF 371632022

HARMAN FINOCHEM LTDLINAGLIPTIN

DMF 388192023

GRANULES INDIA LTDLINAGLIPTIN

DMF 391302024

VIYASH LIFE SCIENCES PRIVATE LTDLINAGLIPTIN

DMF 393362024

BIOCON LTDLINAGLIPTIN PROCESS II

DMF 414752025

SHANDONG NEW TIME PHARMACEUTICAL CO LTDLINAGLIPTIN

DMF 418992025

MSN PHARMACHEM PRIVATE LTDLINAGLIPTIN

DMF 420332025

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDLINAGLIPTIN NON-STERILE DRUG SUBSTANCE

DMF 420412025

SHANKUS PHARMA PRIVATE LTDLINAGLIPTIN IH

DMF 425352025

CTX LIFESCIENCES PVT LTDLINAGLIPTIN

DMF 427932025

VIWIT PHARMACEUTICAL CO LTDInactiveLINAGLIPTIN

DMF 296922015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Jun 21, 2023	SUPPL -27	View Letter (PDF)
Apr 18, 2022	SUPPL -25	View Letter (PDF)
Mar 31, 2020	SUPPL -20	View Letter (PDF)
Jul 5, 2019	SUPPL -18	View Letter (PDF)
Jul 2, 2019	SUPPL -21	View Letter (PDF)
Aug 15, 2017	SUPPL -16	View Letter (PDF)
Mar 20, 2017	SUPPL -14	View Letter (PDF)
Dec 27, 2016	SUPPL -15	View Letter (PDF)
Sep 1, 2015	SUPPL -12	View Letter (PDF)
Jul 29, 2015	SUPPL -11	View Letter (PDF)
May 23, 2014	SUPPL -9	View Letter (PDF)
Jun 20, 2013	SUPPL -6	View Letter (PDF)
Oct 2, 2012	SUPPL -5	View Letter (PDF)
Aug 15, 2012	SUPPL -3	View Letter (PDF)
Aug 15, 2012	SUPPL -4	View Letter (PDF)
May 24, 2012	SUPPL -2	View Letter (PDF)
May 6, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

RLDAB

10 patents2 exclusivities▴

TABLET;ORAL | Approved: May 2, 2011

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8673927	May 4, 2027PED: Nov 4, 2027	PED	—	—		Delisted
8846695	Jun 4, 2030PED: Dec 4, 2030	PED	—	—		Delisted
8853156	Mar 5, 2031PED: Sep 5, 2031	PED	—	Yes		—
8883805	Nov 26, 2025PED: May 26, 2026	PED	—	Yes	—	—
9486526	Aug 5, 2029PED: Feb 5, 2030	PED	—	—		—
10034877	Aug 5, 2029PED: Feb 5, 2030	PED	—	—		—
11033552	May 4, 2027PED: Nov 4, 2027	PED	—	Yes	—	—
11911388	Apr 10, 2030	—	—	—		—
12178819	May 4, 2027	—	—	Yes	—	—
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