LOPERAMIDE HYDROCHLORIDE Drug Patent Profile
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When do Loperamide Hydrochloride patents expire, and what generic alternatives are available?
Loperamide Hydrochloride is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, Able, Contract Pharmacal, L Perrigo Co, LNK, Marksans Pharma, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd. and is included in forty NDAs.
The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Loperamide Hydrochloride
A generic version of LOPERAMIDE HYDROCHLORIDE was approved as loperamide hydrochloride; simethicone by PERRIGO R AND D on September 5th, 2018.
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Questions you can ask:
- What is the 5 year forecast for LOPERAMIDE HYDROCHLORIDE?
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Summary for LOPERAMIDE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 30 |
| NDAs: | 40 |
| Finished Product Suppliers / Packagers: | 102 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 84 |
| Patent Applications: | 4,232 |
| DailyMed Link: | LOPERAMIDE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ohio State University Comprehensive Cancer Center | NA |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | NA |
| Jiangnan University | NA |
Pharmacology for LOPERAMIDE HYDROCHLORIDE
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for LOPERAMIDE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ohm Labs | LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 074091-001 | Dec 10, 1992 | OTC | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Contract Pharmacal | LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 073254-001 | Jul 30, 1993 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Perrigo | LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 074194-001 | Oct 30, 1992 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
