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Last Updated: April 19, 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, 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, Mylan Institutional, and Wyeth Ayerst, and is included in sixty-eight 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:	55
NDAs:	68
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	406
Patent Applications:	6,195
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
Abant Izzet Baysal University	Phase 4
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited	Phase 1
Ann & Robert H Lurie Children's Hospital of Chicago	Phase 2

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
Mankind Pharma	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	218148-001	Jan 8, 2024	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roxane	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086057-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Medpointe Pharm Hlc	COLONAID	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085737-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210571-001	Aug 31, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.