LOPERAMIDE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for loperamide hydrochloride and what is the scope of freedom to operate?
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 three 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: | 103 |
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
Sponsor | Phase |
---|---|
Infectious Diseases Clinical Research Program | Phase 4 |
Henry M. Jackson Foundation for the Advancement of Military Medicine | Phase 4 |
Uniformed Services University of the Health Sciences | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||||
J And J Consumer Inc | IMODIUM A-D EZ CHEWS | loperamide hydrochloride | TABLET, CHEWABLE;ORAL | 020448-001 | Jul 24, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Zydus Lifesciences | LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 217471-001 | Mar 23, 2023 | 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 A-D EZ CHEWS | loperamide hydrochloride | TABLET, CHEWABLE;ORAL | 020448-001 | Jul 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
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 | loperamide hydrochloride | SOLUTION;ORAL | 019487-001 | Mar 1, 1988 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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