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CEPHULAC

NDA

LACTULOSE | N017657 | 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study NCT07140120	—	Active	University of Michigan	52	2023-06-13 → 2026-08
Gut Permeability and Microbiome in Preterm Infants NCT07667049	Phase 1	Not Yet Recruiting	University of Maryland, Baltimore	150	2026-07-15 → 2027-06-30
Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy NCT07589465	N/A	Recruiting	Nanchong Central Hospital	150	2026-06-21 → 2029-06-30

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

Medicare Part D Spending

CMS annual spending data for Kristalose (2023)

Total Spending

$3.8M

Total Claims

6,536

Beneficiaries

3,070

Avg Cost/Unit

$9.41

Spending Trend

$4.1M(2019)→$4.5M(2020)→$4.3M(2021)→$3.8M(2022)→$3.8M(2023)

YoY Change:+4.5%

5yr CAGR:+4.9%

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

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, RECTAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.