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Last Updated: March 19, 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, Saptalis Pharms, 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
Uniformed Services University of the Health SciencesPhase 4
Infectious Diseases Clinical Research ProgramPhase 4
Henry M. Jackson Foundation for the Advancement of Military MedicinePhase 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
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SUSPENSION;ORAL 091292-001 May 20, 2011 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 072741-001 Sep 18, 1991 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Cadista LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 217840-001 Jul 5, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Duramed Pharms Barr LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 074991-001 Dec 29, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Edenbridge Pharms LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 215001-001 Oct 6, 2021 AB RX No 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
Janssen Pharms IMODIUM loperamide hydrochloride SOLUTION;ORAL 019037-001 Jul 31, 1984 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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