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Atropine sulfate - Generic Drug Details

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What are the generic drug sources for atropine sulfate and what is the scope of patent protection?

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

There are twenty-three drug master file entries for atropine sulfate. Seven suppliers are listed for this compound.

Summary for atropine sulfate

US Patents:	0
Tradenames:	19
Applicants:	42
NDAs:	48
Drug Master File Entries:	23
Suppliers / Packagers:	7
Bulk Api Vendors:	102
Clinical Trials:	27
Patent Applications:	6,240
Formulation / Manufacturing:	see details
DailyMed Link:	atropine sulfate at DailyMed

Recent Clinical Trials for atropine sulfate

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

Sponsor	Phase
Ain Shams University	N/A
Rho, Inc.	Phase 1
Biomedical Advanced Research and Development Authority	Phase 1

See all atropine sulfate clinical trials

Pharmacology for atropine sulfate

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

US Patents and Regulatory Information for atropine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scherer Rp	DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	CAPSULE;ORAL	086440-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alpharma Us Pharms	LOMANATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	085746-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Vangard	LO-TROL	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	088009-001	Mar 25, 1983		DISCN	No	No
R And S Pharma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085035-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Hospira	ATROPINE SULFATE ANSYR PLASTIC SYRINGE	atropine sulfate	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL	021146-002	Jul 9, 2001		RX	Yes	Yes
Mylan Institutional	ENLON-PLUS	atropine sulfate; edrophonium chloride	INJECTABLE;INJECTION	019677-001	Nov 6, 1991		DISCN	No	No