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NDA

LOSARTAN POTASSIUM | N218772 | SCIENTURE LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

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2029

2030

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Today

11890273

Oct. 7, 2041

12156869

Oct. 7, 2041

12605365

Oct. 7, 2041

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain30 active DMFs17 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDLOSARTAN POTASSIUM

DMF 169962003

LUPIN LTDLOSARTAN POTASSIUM USP (AMORPHOUS)

DMF 192952006

APITORIA PHARMA PRIVATE LTDLOSARTAN POTASSIUM USP DRUG SUBSTANCE

DMF 196712006

HETERO LABS LTDLOSARTAN POTASSIUM (FORM 1)

DMF 199882006

DR REDDYS LABORATORIES LTDLOSARTAN POTASSIUM FORM-1

DMF 203582007

JUBILANT BIOSYS LTDLOSARTAN POTASSIUM USP

DMF 211772007

CALYX CHEMICALS AND PHARMACEUTICALS LTDLOSARTAN POTASSIUM USP

DMF 219112008

ORCHID PHARMA LTDLOSARTAN POTASSIUM (NON-STERILE BULK API)

DMF 219142008

ALEMBIC PHARMACEUTICALS LTDLOSARTAN POTASSIUM USP

DMF 221162008

ZYDUS LIFESCIENCES LTDLOSARTAN POTASSIUM USP

DMF 223642008

UNICHEM LABORATORIES LTDLOSARTAN POTASSIUM USP

DMF 225562009

GRANULES INDIA LTDLOSARTAN POTASSIUM USP

DMF 227112009

SUVEN LIFE SCIENCES LTDLOSARTAN POTASSIUM USP

DMF 246542011

MICRO LABS LTDLOSARTAN POTASSIUM USP

DMF 246882010

TAPI NL BVLOSARTAN POTASSIUM

DMF 256542012

LUPIN LTDLOSARTAN POTASSIUM USP (CRYSTALLINE)

DMF 258792012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLOSARTAN POTASSIUM USP

DMF 271982013

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDLOSARTAN POTASSIUM

DMF 283462014

VASUDHA PHARMA CHEM LTDLOSARTAN POTASSIUM USP

DMF 325302018

MACLEODS PHARMACEUTICALS LTDLOSARTAN POTASSIUM

DMF 331672018

AURORE LIFE SCIENCES PRIVATE LTDLOSARTAN POTASSIUM USP

DMF 350762020

MSN LIFE SCIENCES PRIVATE LTDLOSARTAN POTASSIUM USP

DMF 356852021

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDLOSARTAN POTASSIUM (L-3)

DMF 362262021

DR REDDYS LABORATORIES LTDLOSARTAN POTASSIUM (FORM-1)

DMF 363872021

IOL CHEMICALS AND PHARMACEUTICALS LTDLOSARTAN POTASSIUM USP

DMF 371062022

ATUL BIOSCIENCE LTDLOSARTAN POTASSIUM USP

DMF 378932022

VIYASH LIFE SCIENCES PRIVATE LTDLOSARTAN POTASSIUM USP

DMF 385312024

SYNERGENE ACTIVE INGREDIENTS PVT LTDLOSARTAN POTASSIUM USP

DMF 389542023

DIVIS LABORATORIES LTDLOSARTAN POTASSIUM USP

DMF 405522024

IPCA LABORATORIES LTDLOSARTAN POTASSIUM USP (LB4 PROCESS)

DMF 407602024

MAPRIMED SAInactiveLOSARTAN POTASSIUM

DMF 163112002

IPCA LABORATORIES LTDInactiveLOSARTAN POTASSIUM

DMF 165262003

IPCA LABORATORIES LTDInactiveLOSARTAN POTASSIUM USP (PROCESS II)

DMF 174602004

MEDICHEM SAInactiveLOSARTAN POTASSIUM

DMF 178332004

LEK PHARMACEUTICALS DDInactiveLOSARTAN POTASSIUM

DMF 178672004

CADILA HEALTHCARE LTDInactiveLOSARTAN POTASSIUM USP

DMF 181532005

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM USP

DMF 186922005

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM

DMF 187802005

CADILA PHARMACEUTICALS LTDInactiveLOSARTAN POTASSIUM USP

DMF 205092007

CIPLA LTDInactiveLOSARTAN POTASSIUM USP

DMF 209672007

MYLAN LABORATORIES LTDInactiveLOSARTAN POTASSIUM USP

DMF 210462007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM USP

DMF 220732008

WANBURY LTDInactiveLOSARTAN POTASSIUM

DMF 221502008

IPCA LABORATORIES LTDInactiveLosartan Potassium USP (LB5 Process)

DMF 222192009

FLAMMA SPAInactiveLOSARTAN POTASSIUM

DMF 233022009

POLYDRUG LABORATORIES PVT LTDInactiveLOSARTAN POTASSIUM

DMF 249152011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM

DMF 257372011

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 19, 2026	SUPPL -2	View Letter (PDF)
Mar 17, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

3 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Mar 13, 2025

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11890273	Oct 7, 2041	—	—	Yes	—	—
12156869	Oct 7, 2041	—	—	Yes		—
12605365	Oct 7, 2041	—	—	Yes		—