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LEVOCETIRIZINE DIHYDROCHLORIDE | N209090 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayIPRPTAB Challenge

2027

Today

8633194

Oct. 16, 2027IPR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2019-00400	8633194	IPR	Apotex Inc. et al.	Final Written Decision	2018-12-13	—

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs2 inactive

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

CIPLA LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 201732007

GLOCHEM INDUSTRIES PRIVATE LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 211102007

SUN PHARMACEUTICAL INDUSTRIES LTDLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 212142008

COHANCE LIFESCIENCES LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 214172008

SYMED LABS LTDLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 222862008

ALIVUS LIFE SCIENCES LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 226772009

GRANULES INDIA LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 228982009

TARO PHARMACEUTICAL INDUSTRIES LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 243432010

JUBILANT PHARMOVA LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 252792012

CHROMO LABORATORIES INDIA PRIVATE LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 332192019

METROCHEM API PRIVATE LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 347312020

WAVELENGTH ENTERPRISES LTDInactiveLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 241612010

SYNTHON BVInactiveLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 245612011

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 9, 2026	SUPPL -7	View Letter (PDF)
Jul 23, 2025	SUPPL -6	View Letter (PDF)
Oct 31, 2022	SUPPL -4	View Letter (PDF)
Jul 14, 2022	SUPPL -3	View Letter (PDF)
Nov 12, 2020	SUPPL -2	View Letter (PDF)
Jan 31, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG/5ML

RLD

1 patent0 exclusivities▴

SOLUTION;ORAL | Approved: Jan 31, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8633194	Oct 16, 2027	—	—	Yes	—	—