Last Updated: June 22, 2026

DIPHENOXYLATE Drug Patent Profile

Name: DIPHENOXYLATE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Diphenoxylate, and what generic alternatives are available?

Diphenoxylate is a drug marketed by Hikma, Able, Ani Pharms, Ascot, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Parke Davis, Pvt Form, Quagen, R And S Pharma, Roxane, Specgx Llc, Strides Pharma Intl, Sun Pharm Industries, Unichem, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, and Scherer Rp. and is included in twenty-nine NDAs.

The generic ingredient in DIPHENOXYLATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

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Summary for DIPHENOXYLATE

US Patents:	0
Applicants:	27
NDAs:	29
Drug Prices:	Drug price information for DIPHENOXYLATE
DailyMed Link:	DIPHENOXYLATE at DailyMed

Drug patent expirations by year for DIPHENOXYLATE

US Patents and Regulatory Information for DIPHENOXYLATE

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Glossary

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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
Winder Labs Llc	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	211362-001	Jan 27, 2021	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Scherer Rp	DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	CAPSULE;ORAL	086440-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	087708-001	May 3, 1982		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Quagen	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210571-001	Aug 31, 2018		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Unichem	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210819-001	Nov 13, 2018	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.