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ATROPINE (AUTOINJECTOR)

NDA

ATROPINE | N212319 | RAFA LABORATORIES LTD

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

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Dr. Robert Gold, MD and Dr. Cheryl Chapman, OD FDA-2026-P-1534 · 3 docket documents Dr. Robert Gold, MD and Dr. Cheryl Chapman, OD filed this citizen petition pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act and 21 CFR §10.30 requesting that the FDA reconsider and expedite regulatory review of SYD-101, a standardized low-dose atropine ophthalmic formulation for p	Other	2026-02-10	Open	Dr. Robert Gold, MD and Dr. Cheryl Chapman, OD
Attachment 2 Atropine Prescribing Information re Suitability Petition from Ph... FDA-2023-P-4550 · 8 docket documents Pharmobedient Consulting LLC filed a suitability petition requesting that the FDA evaluate the prescribing information for atropine to determine its appropriateness and suitability for its intended use. The petition seeks FDA review of the product's labeling under regulatory mechanisms governing dru	Suitability	2023-10-17	Denied	Pharmobedient Consulting LLC
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0134 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP at a strength of 5 mg/0.05 mg per 5 mL suitable for sub	Other	2008-12-24	Denied	Lachman Consultant Services, Inc.
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

115 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 83 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability NCT02078336	Phase 4	Active	Universitaire Ziekenhuizen KU Leuven	40	2013-12 → 2025-07
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)NCT03140358	Phase 3	Active	Singapore National Eye Centre	300	2017-04-21 → 2025-12-31
Low-dose Atropine for Myopia Control in Children NCT03865160	Phase 2/3	Active	University Eye Hospital, Freiburg	302	2021-10-19 → 2027-11
Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom NCT03690089	Phase 2	Active	Belfast Health and Social Care Trust	289	2019-04-03 → 2027-02-02
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery NCT00992901	Early Phase 1	Recruiting	The University of Texas Health Science Center at San Antonio	160	2009-10 → 2027-08
The Effects of Bariatric Surgeries on Glucose Metabolism NCT02823665	Early Phase 1	Recruiting	The University of Texas Health Science Center at San Antonio	200	2015-07 → 2027-08
An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old NCT00094692	Phase 3	Completed	Jaeb Center for Health Research	507	2002-10 → 2005-12
Remifentanil and Atropine for Intubation in Neonates NCT00815048	Phase 4	Completed	King Saud University	30	2006-01 → 2008-02
A Study of Inhaled Atropine Sulfate in Healthy Adults NCT00947596	Phase 1	Completed	MicroDose Defense Products L.L.C.	18	2009-08 → 2010-08
Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation NCT01427985	Phase 4	Completed	University of Ulm	24	2011-06 → 2012-07

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

API Supply Chain1 active DMF4 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ROLABO OUTSOURCING SLATROPINE USP

DMF 295212015

SIGMA F AND D DIV LTDInactiveATROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED

DMF 55141983

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveATROPINE

DMF 57911985

BOEHRINGER INGELHEIM PHARMA KGInactiveATROPINE METHYLNITRATE

DMF 73341988

C-SQUARED PHARMA SARLInactiveATROPINE

DMF 357692021

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2023	SUPPL -7	View Letter (PDF)
Jul 10, 2019	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Jul 9, 2018

No patent or exclusivity listings for this strength.