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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy NCT07558226	N/A	Recruiting	Fundacio Puigvert	80	2026-05-02 → 2027-11-30

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

Medicare Part D Spending

CMS annual spending data for Transderm-Scop (2023)

Total Spending

$356K

Total Claims

1,759

Beneficiaries

788

Avg Cost/Unit

$20.44

Spending Trend

$13.0M(2019)→$2.3M(2020)→$1.0M(2021)→$465K(2022)→$356K(2023)

YoY Change:-0.3%

5yr CAGR:-2.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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.