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ATROPINE SULFATE

NDA

ATROPINE SULFATE | N020056 | UNITED STATES ARMY OFFICE SURGEON GENERAL

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 4 Draft Guidance on Atropine Sulfate re Suitability Petition from ... FDA-2023-P-4550 Pharmobedient Consulting LLC filed a petition regarding atropine sulfate seeking FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations. The petition requests clarification on regulatory pathways and acceptance criteria for atropine sulfate submissions under app	Suitability	2023-10-17	Open	Pharmobedient Consulting LLC

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

Clinical Trials

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

Trial	Phase	Status	Sponsor	Enrollment	Dates
Atropine Eye Drops for Watery Eyes (Excessive Tearing)NCT07676981	Phase 2	Recruiting	Rehan Ahmed	18	2026-06 → 2026-07
Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial NCT07567040	Phase 3	Recruiting	Ohio State University	664	2026-05-27 → 2028-05-15
An Investigation of Topical Ophthalmic Low-Dose Atropine on Pupil Size and Accommodation NCT07674966	Phase 1	Completed	University of California, Berkeley	24	2022-03-16 → 2022-10-09

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

Medicare Part D Spending

CMS annual spending data for Atropine Sulfate (2023)

Total Spending

$17K

Total Claims

358

Beneficiaries

239

Avg Cost/Unit

$4.38

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

Medicare Part B Spending

CMS physician-administered drug spending for Atropine Sulfate (2023)

Total Spending

$190K

Total Claims

50,725

Beneficiaries

9,280

ASP Price

—

HCPCS: J0461 — Injection, atropine sulfate, 0.01 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain11 active DMFs1 inactive

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

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 289782014

ROLABO OUTSOURCING SLATROPINE SULFATE USP

DMF 293962015

SCL LIFESCIENCES LTDATROPINE SULFATE USP

DMF 296052015

RESONANCE LABORATORIES PVT LTDATROPINE SULFATE

DMF 298032015

MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 302272016

C-SQUARED PHARMA LTDATROPINE SULFATE USP

DMF 306052016

ALCHEM INTERNATIONAL PRIVATE LTDATROPINE SULFATE USP

DMF 312782016

MATRIX PHARMACORP PRIVATE LTDATROPINE SULFATE USP

DMF 322902017

SS PHARMA LLCATROPINE SULFATE MONOHYDRATE USP

DMF 337812019

HENAN PURUI PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 364842021

FLOWCHEM PHARMA PVT LTDATROPINE SULFATE USP

DMF 422992025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveATROPINE SULFATE

DMF 54941984

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

Products (1)

#001 — EQ 0.36MG BASE/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Sep 19, 1990

No patent or exclusivity listings for this strength.