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Last Updated: November 3, 2024

LOPERAMIDE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for loperamide hydrochloride and what is the scope of freedom to operate?

Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Janssen Pharms, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for loperamide hydrochloride. One hundred and three suppliers are listed for this compound.

Summary for LOPERAMIDE HYDROCHLORIDE
US Patents:0
Tradenames:6
Applicants:31
NDAs:45
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 103
Raw Ingredient (Bulk) Api Vendors: 117
Clinical Trials: 76
Patent Applications: 7,180
What excipients (inactive ingredients) are in LOPERAMIDE HYDROCHLORIDE?LOPERAMIDE HYDROCHLORIDE excipients list
DailyMed Link:LOPERAMIDE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE

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

SponsorPhase
Infectious Diseases Clinical Research ProgramPhase 4
Henry M. Jackson Foundation for the Advancement of Military MedicinePhase 4
Uniformed Services University of the Health SciencesPhase 4

See all LOPERAMIDE HYDROCHLORIDE clinical trials

Pharmacology for LOPERAMIDE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for LOPERAMIDE HYDROCHLORIDE

US Patents and Regulatory Information for LOPERAMIDE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 209837-001 Sep 5, 2018 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 217471-001 Mar 23, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LOPERAMIDE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc IMODIUM loperamide hydrochloride CAPSULE;ORAL 017694-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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. 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.