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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 patent protection?
Loperamide hydrochloride; simethicone
is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, Perrigo, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for loperamide hydrochloride; simethicone. Eighteen suppliers are listed for this compound.
Summary for loperamide hydrochloride; simethicone
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 18 |
| Clinical Trials: | 5 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for loperamide hydrochloride; simethicone |
| 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 |
| Rocky Mountain MS Research Group, LLC | Phase 4 |
| Biogen | Phase 4 |
See all loperamide hydrochloride; simethicone clinical trials
Recent Litigation for loperamide hydrochloride; simethicone
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALDERMAN v. MCNEIL-PPC, INC. | 2002-06-27 |
Paragraph IV (Patent) Challenges for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| IMODIUM MULTI-SYMPTOM RELIEF | TABLET;ORAL | loperamide hydrochloride; simethicone | 021140 | 2004-12-29 |
| IMODIUM MULTI-SYMPTOM RELIEF | TABLET, CHEWABLE;ORAL | loperamide hydrochloride; simethicone | 020606 |
US Patents and Regulatory Information for loperamide hydrochloride; simethicone
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 | Start Trial | Start Trial |
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140-001 | Nov 30, 2000 | Start Trial | Start Trial |
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET, CHEWABLE;ORAL | 020606-001 | Jun 26, 1996 | Start Trial | Start Trial |
| J And J Consumer Inc | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140-001 | Nov 30, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
