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Last Updated: November 22, 2024

Atropine - Generic Drug Details

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

Atropine is the generic ingredient in twenty-two branded drugs marketed by MMT, Abbvie, Rafa Labs Ltd, Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, Hikma, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, Vangard, Superpharm, Pfizer, Halsey, Norvium Bioscience, and Wyeth Ayerst, and is included in seventy-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for atropine

US Patents:	0
Tradenames:	22
Applicants:	57
NDAs:	71
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	416
Patent Applications:	7,185
Drug Prices:	Drug price trends for atropine
What excipients (inactive ingredients) are in atropine?	atropine excipients list
DailyMed Link:	atropine at DailyMed

Drug Prices for atropine

See drug prices for atropine

Recent Clinical Trials for atropine

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

Sponsor	Phase
Southern California College of Optometry at Marshall B. Ketchum University	Phase 1
Ohio State University	Phase 1
Indiana University	Phase 1

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

Anatomical Therapeutic Chemical (ATC) Classes for atropine

A03BA	Belladonna alkaloids, tertiary amines
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for atropine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Us Army	ATNAA	atropine; pralidoxime chloride	INJECTABLE;INTRAMUSCULAR	021175-001	Jan 17, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	ENLON-PLUS	atropine sulfate; edrophonium chloride	INJECTABLE;INJECTION	019678-001	Nov 6, 1991		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	218148-001	Jan 8, 2024	AT1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascot	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	087934-001	Jul 19, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medpointe Pharm Hlc	COLONAID	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	085735-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Pharm Intl	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	087195-001	Feb 16, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	ENLON-PLUS	atropine sulfate; edrophonium chloride	INJECTABLE;INJECTION	019677-001	Nov 6, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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