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Last Updated: August 17, 2022

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, Bionpharma Inc, Chartwell Rx, Edenbridge Pharms, Mylan, Roxane, Strides Pharma, Teva, Janssen Pharms, Akorn, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma Ltd, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty 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
Spanish Breast Cancer Research GroupPhase 2
Pierre Fabre LaboratoriesPhase 2
Chinese Academy of Medical SciencesPhase 2

See all loperamide hydrochloride clinical trials

Pharmacology for loperamide hydrochloride
Drug ClassOpioid Agonist
Mechanism of Action Opioid 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
Roxane LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 073080-001 Nov 27, 1991 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Perrigo LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 073243-001 Jan 21, 1992 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 072993-001 Aug 28, 1992 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wockhardt Bio Ag LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 074730-001 Aug 28, 1997 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Contract Pharmacal LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 073254-001 Jul 30, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 073478-001 Jun 23, 1995 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
J And J Consumer Inc IMODIUM loperamide hydrochloride CAPSULE;ORAL 017690-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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