LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Drug Patent Profile
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When do Loperamide Hydrochloride And Simethicone patents expire, and what generic alternatives are available?
Loperamide Hydrochloride And Simethicone is a drug marketed by Perrigo, Aurobindo Pharma Ltd, Bionpharma, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd. and is included in eight NDAs.
The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-one 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 And Simethicone
A generic version of LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE was approved as loperamide hydrochloride; simethicone by PERRIGO R AND D on September 5th, 2018.
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Summary for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| DailyMed Link: | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE at DailyMed |
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McNeil AB | Phase 1 |
| Rocky Mountain MS Research Group, LLC | Phase 4 |
| Biogen | Phase 4 |
See all LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE clinical trials
Pharmacology for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Skin Barrier Activity |
US Patents and Regulatory Information for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Perrigo | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 076029-001 | Aug 30, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo R And D | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 209837-001 | Sep 5, 2018 | OTC | No | No | ⤷ 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
