ATROPINE - Generic Drug Details

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, 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, and Wyeth Ayerst, and is included in seventy-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine. Two suppliers are listed for this compound.

Summary for ATROPINE

US Patents:	0
Tradenames:	22
Applicants:	57
NDAs:	71
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	416
Patent Applications:	7,185
Drug Prices:	Drug price trends for ATROPINE
What excipients (inactive ingredients) are in ATROPINE?	ATROPINE excipients list
DailyMed Link:	ATROPINE at DailyMed

See drug prices for ATROPINE

Recent Clinical Trials for ATROPINE

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

Sponsor	Phase
Case Western Reserve University	Phase 1
State University of New York	Phase 1
Southern California College of Optometry at Marshall B. Ketchum University	Phase 1

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scherer Rp	DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	CAPSULE;ORAL	086440-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Winder Labs Llc	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	211362-001	Jan 27, 2021	AA	RX	No	No
Mylan	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085762-001	Approved Prior to Jan 1, 1982		DISCN	No	No