Loperamide hydrochloride; simethicone - Generic Drug Details
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What are the generic drug sources for loperamide hydrochloride; simethicone and what is the scope of freedom to operate?
Loperamide hydrochloride; simethicone
is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, 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 ten NDAs. Additional information is available in the individual branded drug profile pages.Thirty-one suppliers are listed for this compound.
Summary for loperamide hydrochloride; simethicone
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 31 |
| Clinical Trials: | 5 |
| DailyMed Link: | loperamide hydrochloride; simethicone at DailyMed |
Recent Clinical Trials for loperamide hydrochloride; simethicone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McNeil AB | Phase 1 |
| Biogen | Phase 4 |
| Rocky Mountain MS Research Group, LLC | Phase 4 |
See all loperamide hydrochloride; simethicone clinical trials
Pharmacology for loperamide hydrochloride; simethicone
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Skin Barrier Activity |
Anatomical Therapeutic Chemical (ATC) Classes for loperamide hydrochloride; simethicone
Paragraph IV (Patent) Challenges for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| IMODIUM MULTI-SYMPTOM RELIEF | Tablets | loperamide hydrochloride; simethicone | 2 mg/125 mg | 021140 | 2004-12-29 |
US Patents and Regulatory Information for loperamide hydrochloride; simethicone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 020606-001 | Jun 26, 1996 | DISCN | Yes | 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 | ||||
| Hetero Labs Ltd V | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211438-001 | Jun 17, 2021 | OTC | 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 | ||||
| >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; simethicone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 020606-001 | Jun 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 020606-001 | Jun 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 020606-001 | Jun 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140-001 | Nov 30, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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