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NDA

LACTULOSE | N017884 | SANOFI AVENTIS US LLC

1 strength0 unique patents0 unique exclusivities

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

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

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4150 · 14 docket documents The law firm Hyman, Phelps & McNamara submitted a suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Lactulose for Oral Solution, 15 g/Packet, suitable for submission as an AN	Suitability	2025-09-23	Open	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Bennett and Company FDA-1992-P-0330 · 4 docket documents Bennett and Company filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting permission to submit an abbreviated new drug application for lactulose crystals that would be reconstituted with water to form a liquid for oral administration, with the l	Other	2019-01-31	Granted	Bennett and Company
Cumberland Pharmaceuticals Inc. - Citizen Petition FDA-2012-P-0496 · 5 docket documents Cumberland Pharmaceuticals Inc. filed this suitability petition under Section 505(j)(2)(c) requesting permission to submit an abbreviated new drug application for KRISTALOSE lactulose crystals in 10 and 20 gram formulations for prevention and treatment of portal systemic encephalopathy, using ENULOS	Other	2012-05-18	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

74 trials from ClinicalTrials.gov — 1 recruiting, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose NCT04073290	Phase 4	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	238	2020-01-21 → 2026-12-31
Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2 NCT03666546	Phase 4	Completed	Fresenius Kabi	24	2018-11-26 → 2019-03-08
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE NCT01446523	N/A	Completed	Govind Ballabh Pant Hospital	60	2011-10 → 2012-02
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy NCT01842581	Phase 4	Completed	Bausch Health Americas, Inc.	222	2013-01-08 → 2014-12-17
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.NCT01231828	N/A	Completed	University Hospital, Caen	55	2009-09 → 2012-12
To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism NCT02265484	N/A	Completed	Institute of Liver and Biliary Sciences, India	50	2013-11 → 2015-01
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia NCT00956397	N/A	Completed	Henry C. Lin, MD	55	2007-08
Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients NCT02017119	Phase 2	Completed	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	40	2011-01 → 2014-06
Breath and Blood Ammonia Response to an Oral Protein Challenge NCT02650245	N/A	Completed	St. Luke's Hospital and Health Network, Pennsylvania	12	2015-10 → 2016-04
Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF NCT04238416	Phase 1	Completed	Post Graduate Institute of Medical Education and Research, Chandigarh	70	2019-11-01 → 2021-12-30

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

API Supply Chain11 active DMFs10 inactive

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

INALCO SAS DI GIOVANNI CIPOLLETTI AND CLACTULOSE 50% SYRUP

DMF 54121984

RELAX LTDLACTULOSE CONCENTRATE USP

DMF 81951989

DANIPHARM ASLACTULOSE CONCENTRATE

DMF 87601990

ABBOTT LABORATORIES COLACTULOSE CONCENTRATE USP

DMF 101451993

FRESENIUS KABI AUSTRIA GMBHLACTULOSE SOLUTION USP

DMF 152532001

FRESENIUS KABI AUSTRIA GMBHLACTULOSE CRYSTALS

DMF 152542001

FRESENIUS KABI AUSTRIA GMBHLACTULOSE CONCENTRATE USP

DMF 205622007

SYNGARS TECHNOLOGY CO LTDLACTULOSE

DMF 382522023

LACTOSE (INDIA) LTDLACTULOSE CONCENTRATE USP

DMF 390392024

BAOLINGBAO BIOLOGY CO LTDLACTULOSE CONCENTRATE

DMF 421812025

API PHARMA TECH LLCLACTULOSE

DMF 426052025

SOLVAY DUPHAR BVInactiveLACTULOSE SOLUTION

DMF 8351964

LAEVOSAN GMBH AND CO KGInactiveLACTULOSE CONCENTRATE (BULK)

DMF 35871979

MORINAGA MILK INDUSTRY CO LTDInactiveLACTULOSE SYRUP (MLS-50)

DMF 52561984

ZAMBON SPAInactiveLACTULOSE

DMF 78331988

INALCO SPAInactiveLACTULOSE CRYSTALS

DMF 95371992

INALCO SPAInactiveLACTULOSE CRYSTALS

DMF 112621994

SOLVAY DUPHAR BVInactiveLACTULOSE CONCENTRATE

DMF 114481995

SOLVAY DUPHAR BVInactiveLACTULOSE CRYSTALLINE

DMF 126991997

DANIPHARM ASInactiveLACTULOSE PURUM LIQUIDUM

DMF 183892005

FRESENIUS KABI AUSTRIA GMBHInactiveLACTULOSE SOLUTION USP

DMF 223282008

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

Products (1)

#001 — 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.