Viewing data from:

TRANSDERM SCOP

NDA

SCOPOLAMINE | N017874 | BAXTER HEALTHCARE CORP

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

43 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Multimodal Analgesia Effect on Post Surgical Patient NCT04240626	Phase 4	Active	University of California, Davis	60	2021-01-20 → 2026-06-24
Toward a Computationally-Informed, Personalized Treatment for Hallucinations NCT04366518	Early Phase 1	Recruiting	Yale University	35	2021-07-15 → 2032-08
The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope NCT02811341	Phase 1	Completed	Shandong University	122	2014-08 → 2015-06
Effects of Hallucinogens and Other Drugs on Mood and Performance NCT02033707	Phase 1	Completed	Johns Hopkins University	20	2014-04 → 2019-02
Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects NCT03988530	Phase 3	Completed	Repurposed Therapeutics, Inc.	98	2019-06-07 → 2020-11-23
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting NCT00659737	N/A	Completed	Drexel University College of Medicine	115	2008-04 → 2010-03
Motion Sickness Medications and Vestibular Time Constant NCT03270839	Phase 4	Completed	Medical Corps, Israel Defense Force	54	2017-06-01 → 2020-01-01
The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study NCT02273895	N/A	Completed	Mentis Cura	29	2004-04 → 2010-01
Scopolamine Patch Pharmacokinetics in Healthy Adults NCT03029650	Phase 4	Completed	University of Iowa	26	2016-11 → 2018-03
Effects of Transdermal Scopolamine on Occupational Performance NCT00374478	Phase 2	Completed	Boston University	33	2005-04 → 2006-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$11.24

per ea

Lowest NADAC/Unit

$11.24

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
10019000810TRANSDERM-SCOP 1 MG/3 DAY PTCH	$11.24	EA	Brand	$4.38	2026-06-17
10019000824TRANSDERM-SCOP 1 MG/3 DAY PTCH	$11.24	EA	Brand	$4.38	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 | 2 NDCs (2 FSS)

Lowest Price

$53.87

Highest Price

$129.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
10019-0008-10TRANSDERM SCOP 0.33MG/24HRS TDS	$53.87	FSS	Baxter Healthcare Corporation	08/14/2026
10019-0008-24TRANSDERM SCOP 0.33MG/24HRS TDS	$129.29	FSS	Baxter Healthcare Corporation	08/14/2026

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

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Scopolamine (2024)

Total Spending

$31.2M

Total Claims

398,915

Beneficiaries

229,942

Avg Cost/Unit

$11.60

Spending Trend

$8.7M(2019)→$18.5M(2020)→$19.5M(2021)→$26.0M(2022)→$30.0M(2023)→$31.2M(2024)

YoY Change:-11.1%

5yr CAGR:-7.3%

Transderm-Scop (2024)

Total Spending

$291K

Total Claims

1,636

Beneficiaries

768

Avg Cost/Unit

$19.96

Spending Trend

$13.0M(2019)→$2.3M(2020)→$1.0M(2021)→$444K(2022)→$348K(2023)→$291K(2024)

YoY Change:-2.5%

5yr CAGR:-2.2%

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

API Supply Chain6 active DMFs6 inactive

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

PHYTEX AUSTRALIA PARTY LTDSCOPOLAMINE BASE

DMF 74081988

PHYTEX AUSTRALIA PVT LTDSCOPOLAMINE HYDROBROMIDE

DMF 74151988

PHYTEX AUSTRALIA PARTY LTDSCOPOLAMINE METHONITRATE

DMF 74171988

FINE CHEMICALS CORP PTY LTDSCOPOLAMINE (HYOSCINE)

DMF 253162011

ALCHEM INTERNATIONAL PRIVATE LTDSCOPOLAMINE HYDROBROMIDE USP

DMF 307212016

ALKALOIDS CORPSCOPOLAMINE HYDROBROMIDE

DMF 317082017

BOEHRINGER INGELHEIM PHARMA KGInactiveSCOPOLAMINE AMINOXIDE HYDROBROMIDE

DMF 36221979

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveSCOPOLAMINE HYDROBROMIDE

DMF 61521983

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveSCOPOLAMINE

DMF 87231990

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveSCOPOLAMINE (HYOSCINE)

DMF 197742006

VITAL LABORATORIES PVT LTDInactiveSCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL BROMIDE)

DMF 244772010

VITAL LABORATORIES PVT LTDInactiveSCOPOLAMINE HYDRO BROMIDE USP

DMF 256132011

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Sep 8, 2025	SUPPL -52	View Letter (PDF)
May 1, 2025	SUPPL -53	View Letter (PDF)
Mar 4, 2024	SUPPL -51	View Letter (PDF)
Mar 5, 2019	SUPPL -44	View Letter (PDF)
Mar 5, 2019	SUPPL -43	View Letter (PDF)
Jun 12, 2018	SUPPL -42	View Letter (PDF)
May 2, 2013	SUPPL -38	View Letter (PDF)
Jan 16, 2007	SUPPL -35	View Letter (PDF)
Mar 22, 2002	SUPPL -32	View Letter (PDF)
Jul 26, 2001	SUPPL -27	View Letter (PDF)
Jul 26, 2001	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/72HR

RLDAB

0 patents0 exclusivities▴

SYSTEM;TRANSDERMAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.