Viewing data from:

LOMOTIL

NDA

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | N012462 | PFIZER INC

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

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0381 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on April 25, 2005, requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP 5 mg/0.05 mg suitable for submission as an ANDA based on the reference listed drug Lomotil Tablets 2.5 mg/0.025 mg. The petition seeks	Other	2008-12-24	Denied	Lachman Consultant Services, Inc.

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas NCT03030417	Phase 1	Completed	National Cancer Institute (NCI)	36	2017-02-27 → 2023-10-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.1384

per ea

Lowest NADAC/Unit

$0.1384

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762106101DIPHENOXYLATE-ATROPINE 2.5-0.025 MG TABLET	$0.1384	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$18.13

Highest Price

$307.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-1061-01ATROPINE SO4 0.025MG/DIPHENOXYLATE HCL 2.5MG	$30.61	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-1061-01ATROPINE SO4 0.025MG/DIPHENOXYLATE HCL 2.5MG	$18.13	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00025-0061-31LOMOTIL TABLETS	$307.93	FSS	Pfizer Inc.	06/30/2029
00025-0061-31LOMOTIL TABLETS	$227.45	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Lomotil (2024)

Total Spending

$247K

Total Claims

773

Beneficiaries

306

Avg Cost/Unit

$2.83

Spending Trend

$429K(2019)→$386K(2020)→$326K(2021)→$246K(2022)→$218K(2023)→$247K(2024)

YoY Change:-2.2%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 14, 2018	SUPPL -48	View Letter (PDF)
Oct 6, 2017	SUPPL -45	View Letter (PDF)
May 2, 2006	SUPPL -42	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.025MG;2.5MG

RLDAA

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.