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Last Updated: February 22, 2024

Loperamide hydrochloride - Generic Drug Details


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What are the generic drug sources for loperamide hydrochloride and what is the scope of patent protection?

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, Akorn, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, 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. Ninety-nine suppliers are listed for this compound.

Summary for loperamide hydrochloride
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
Aurobindo Pharma LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 206548-001 Dec 15, 2015 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 213484-001 Sep 10, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 021855-001 Aug 4, 2005 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 loperamide hydrochloride CAPSULE;ORAL 017694-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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