You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Loperamide hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, 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 four 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: 104
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
Mylan LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 072741-001 Sep 18, 1991 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 215981-001 Aug 29, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 213484-001 Sep 10, 2021 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Jubilant Cadista LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 217840-001 Jul 5, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Guardian Drug LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 214541-001 May 27, 2021 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 021855-002 Aug 4, 2005 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Edenbridge Pharms LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 215001-001 Oct 6, 2021 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 loperamide hydrochloride CAPSULE;ORAL 017694-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
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 A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 ⤷  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
Janssen Pharms IMODIUM loperamide hydrochloride SOLUTION;ORAL 019037-001 Jul 31, 1984 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.