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IMODIUM Drug Profile
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» See Plans and PricingWhich 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. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
US ANDA Litigation and Generic Entry Outlook for Imodium
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for IMODIUM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 8 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 22 |
| Patent Applications: | 3,982 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for IMODIUM |
| DailyMed Link: | IMODIUM at DailyMed |
Recent Clinical Trials for IMODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Naia Pharmaceuticals | Phase 1/Phase 2 |
| McNeil AB | Phase 1 |
| Allergan | 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 | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | IMODIUM A-D EZ CHEWS | loperamide hydrochloride | TABLET, CHEWABLE;ORAL | 020448-001 | Jul 24, 1997 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| J And J Consumer Inc | IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487-001 | Mar 1, 1988 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 020606-001 | Jun 26, 1996 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | IMODIUM | loperamide hydrochloride | CAPSULE;ORAL | 017694-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
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 | Start Trial | Start Trial |
| Janssen Pharms | IMODIUM | loperamide hydrochloride | SOLUTION;ORAL | 019037-001 | Jul 31, 1984 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IMODIUM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | S55120576 | Start Trial |
| Belgium | 767798 | Start Trial |
| Yugoslavia | 137671 | Start Trial |
| Hong Kong | 78076 | Start Trial |
| Poland | 81548 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for IMODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0428296 | SPC/GB98/013 | United Kingdom | Start Trial | PRODUCT NAME: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE; REGISTERED: UK 00242/0314 19970923 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
