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Last Updated: January 25, 2021

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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, Mylan, Roxane, Teva, Yaopharma Co Ltd, 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, and Sun Pharm Inds Ltd, and is included in thirty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for loperamide hydrochloride. Ninety-nine suppliers are listed for this compound.

Recent Clinical Trials for loperamide hydrochloride

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

SponsorPhase
TakedaPhase 2
SOLTI Breast Cancer Research GroupPhase 2
Jiangsu HengRui Medicine Co., Ltd.Phase 1

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
Sun Pharm Inds Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 077500-001 Sep 6, 2006 OTC No No   Start Trial   Start Trial   Start Trial
Mylan LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 072741-001 Sep 18, 1991 AB RX No Yes   Start Trial   Start Trial   Start Trial
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 074730-001 Aug 28, 1997 OTC No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc IMODIUM loperamide hydrochloride CAPSULE;ORAL 017690-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 DISCN Yes No   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Janssen Pharms IMODIUM loperamide hydrochloride SOLUTION;ORAL 019037-001 Jul 31, 1984   Start Trial   Start Trial
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988   Start Trial   Start Trial
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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