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Last Updated: January 30, 2023

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 MMT, Abbvie, Rafa Labs Ltd, Us Army, Akorn, Amneal, Apotex Inc, Bausch And Lomb Inc, 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, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mayne Pharma Inc, 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, Mylan Institutional, and Wyeth Ayerst, and is included in sixty-seven 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:	54
NDAs:	67
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	389
Patent Applications:	5,355
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

Drug Prices for atropine

See drug prices for atropine

Recent Clinical Trials for atropine

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

Sponsor	Phase
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
National Institute of Cardiovascular Diseases, Karachi	Phase 4
Erasmus Medical Center	Phase 3

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

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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
Am Regent	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	216120-001	May 26, 2022	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mmt	DUODOTE	atropine; pralidoxime chloride	INJECTABLE;INTRAMUSCULAR	021983-001	Sep 28, 2006		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Accord Hlthcare	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	213424-001	Mar 19, 2021	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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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Serving leading biopharmaceutical companies globally:

Dow

Mallinckrodt

Merck

Boehringer Ingelheim

Colorcon

AstraZeneca

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