IMODIUM Drug Patent Profile
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Which patents cover Imodium, and what generic alternatives are available?
Imodium is a drug marketed by J And J Consumer Inc and Janssen Pharms and is included in eight NDAs.
The generic ingredient in IMODIUM 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 Imodium
A generic version of IMODIUM was approved as loperamide hydrochloride; simethicone by PERRIGO R AND D on September 5th, 2018.
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Summary for IMODIUM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 25 |
| Patent Applications: | 2,902 |
| What excipients (inactive ingredients) are in IMODIUM? | IMODIUM excipients list |
| DailyMed Link: | IMODIUM at DailyMed |
Recent Clinical Trials for IMODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MedSIR | Phase 2 |
| Gilead Sciences | Phase 2 |
| 9 Meters Biopharma, Inc. | Phase 1/Phase 2 |
US Patents and Regulatory Information for IMODIUM
| 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 | loperamide hydrochloride | CAPSULE;ORAL | 017690-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 | ||||
| J And J Consumer Inc | IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487-001 | Mar 1, 1988 | OTC | Yes | Yes | ⤷ 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 IMODIUM
| 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 |
| 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 |
International Patents for IMODIUM
See the table below for patents covering IMODIUM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 2126559 | ⤷ Sign Up | |
| Japan | S5754508 | ⤷ Sign Up | |
| Belgium | 767798 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IMODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0428296 | SPC/GB98/013 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE; REGISTERED: UK 00242/0314 19970923 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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