Atropine sulfate - Generic Drug Details

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, 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, Abbvie, and Wyeth Ayerst, and is included in sixty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for atropine sulfate

US Patents:	0
Tradenames:	17
Applicants:	53
NDAs:	63
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	50
Patent Applications:	6,444
Formulation / Manufacturing:	see details
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085372-001	Approved Prior to Jan 1, 1982	AA	RX	No	No
Accord Hlthcare	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	213424-001	Mar 19, 2021	AP	RX	No	No
Hospira	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	021146-001	Jul 9, 2001	AP	RX	Yes	Yes
Am Regent	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	216120-001	May 26, 2022	AP	RX	No	No
Sun Pharm Industries	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085506-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	207128-001	Oct 21, 2020	AA	RX	No	No
Wyeth Ayerst	MEPERIDINE AND ATROPINE SULFATE	atropine sulfate; meperidine hydrochloride	INJECTABLE;INJECTION	085121-001	Approved Prior to Jan 1, 1982		DISCN	No	No