Atropine sulfate - Generic Drug Details

What are the generic drug sources for atropine sulfate and what is the scope of freedom to operate?

Atropine sulfate is the generic ingredient in seventeen branded drugs marketed by Us Army, Akorn, Amneal, Apotex Inc, Bausch And Lomb Inc, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, 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, Abbvie, and Wyeth Ayerst, and is included in sixty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for atropine sulfate. Seventeen suppliers are listed for this compound.

Summary for atropine sulfate

US Patents:	0
Tradenames:	17
Applicants:	51
NDAs:	61
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	49
Patent Applications:	19
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
Shanghai Eye Disease Prevention and Treatment Center	N/A
Peking University People's Hospital	N/A
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	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

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
Fosun Pharma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086173-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mylan	ENLON-PLUS	atropine sulfate; edrophonium chloride	INJECTABLE;INJECTION	019678-001	Nov 6, 1991		DISCN	Yes	No
Hospira	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	021146-001	Jul 9, 2001	AP	RX	Yes	Yes
Amneal	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	215342-001	Jan 26, 2022	AP	RX	No	No
Intl Medication Sys	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	212461-001	Oct 5, 2020	AP	RX	No	No
Wyeth Ayerst	MEPERIDINE AND ATROPINE SULFATE	atropine sulfate; meperidine hydrochloride	INJECTABLE;INJECTION	085121-002	Approved Prior to Jan 1, 1982		DISCN	No	No