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Atropine - Generic Drug Details

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What are the generic sources for atropine and what is the scope of freedom to operate?

Atropine is the generic ingredient in twenty-two branded drugs marketed by Meridian Medcl Techn, Abbvie, Rafa Labs Ltd, Us Army, Akorn, Alcon Labs Inc, Accord Hlthcare, Hospira, Intl Medication Sys, Fresenius Kabi Usa, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Hikma Pharms, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Eci Pharms Llc, Fosun Pharma, Heather, Hikma, Inwood Labs, Kv Pharm, Lannett, Leading Pharma Llc, Lederle, Mayne Pharma Inc, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, Vangard, Superpharm, Pfizer, Halsey, Mylan Institutional, Wyeth Ayerst, and Meridian Medcl, and is included in sixty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine. One supplier is listed for this compound.

Summary for atropine

US Patents:	0
Tradenames:	22
Applicants:	51
NDAs:	60
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	298
Patent Applications:	6,387
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for atropine
What excipients (inactive ingredients) are in atropine?	atropine excipients list
DailyMed Link:	atropine at DailyMed

See drug prices for atropine

Recent Clinical Trials for atropine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aya Sabry Mohamed Mohamed	Phase 4
University of Southern California	Phase 4
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	N/A

See all atropine clinical trials

Pharmacology for atropine

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for atropine

Adjuvants, Anesthesia

Anti-Arrhythmia Agents

Bronchodilator Agents

Muscarinic Antagonists

Mydriatics

Parasympatholytics

US Patents and Regulatory Information for atropine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vangard	LO-TROL	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	088009-001	Mar 25, 1983		DISCN	No	No
Upsher Smith Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210571-001	Aug 31, 2018	AA	RX	No	No
Akorn	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	206289-001	Jul 18, 2014		RX	Yes	Yes
Hospira	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	021146-005	Aug 17, 2017	AP	RX	Yes	Yes
Inwood Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085509-001	Approved Prior to Jan 1, 1982		DISCN	No	No