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LINAGLIPTIN

ANDA

LINAGLIPTIN | A208431 | MYLAN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TRADJENTA(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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. 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).

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

1 letter from Drugs@FDA

Date	Submission	Document
Jan 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 3, 2025

No patent or exclusivity listings for this strength.