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Last Updated: November 22, 2024

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 seventeen branded drugs marketed by 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, Abbvie, and Wyeth Ayerst, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for atropine sulfate

US Patents:	0
Tradenames:	17
Applicants:	55
NDAs:	66
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	50
Patent Applications:	6,405
What excipients (inactive ingredients) are in atropine sulfate?	atropine sulfate excipients list
DailyMed Link:	atropine sulfate at DailyMed

Recent Clinical Trials for atropine sulfate

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

Sponsor	Phase
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited	Phase 1
Shandong University of Traditional Chinese Medicine	N/A
Shanghai Eye Disease Prevention and Treatment Center	N/A

See all atropine sulfate clinical trials

Pharmacology for atropine sulfate

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

Anatomical Therapeutic Chemical (ATC) Classes for atropine sulfate

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 sulfate

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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
Wyeth Ayerst	MEPERIDINE AND ATROPINE SULFATE	atropine sulfate; meperidine hydrochloride	INJECTABLE;INJECTION	085121-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	214652-001	Sep 29, 2020	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	087765-001	Mar 15, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Able	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	040395-001	Nov 27, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fosun Pharma	LONOX	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085311-002	Approved Prior to Jan 1, 1982		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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