ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for atropine sulfate; diphenoxylate hydrochloride and what is the scope of patent protection?

Atropine sulfate; diphenoxylate hydrochloride is the generic ingredient in ten branded drugs marketed by Scherer Rp, Medpointe Pharm Hlc, Hikma, 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, and Halsey, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-one suppliers are listed for this compound.

Summary for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

US Patents:	0
Tradenames:	10
Applicants:	36
NDAs:	39
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	1
Patent Applications:	122
DailyMed Link:	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

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

Sponsor	Phase
University of California, San Francisco	Phase 2
Puma Biotechnology, Inc.	Phase 2
Napo Pharmaceuticals, Inc.	Phase 2

See all ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE clinical trials

Pharmacology for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

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

US Patents and Regulatory Information for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	087708-001	May 3, 1982		RX	No	Yes
Gd Searle Llc	LOMOTIL	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	012699-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Heather	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086798-001	Approved Prior to Jan 1, 1982		DISCN	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
Superpharm	LOGEN	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	088962-001	May 10, 1985		DISCN	No	No
Lederle	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086950-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Usl Pharma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	087842-001	Mar 29, 1982		DISCN	No	No