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PLENVU Drug Profile
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Which patents cover Plenvu, and what generic alternatives are available?
Plenvu is a drug marketed by Salix and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixteen patent family members in thirty-five countries.
The generic ingredient in PLENVU is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Plenvu
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for PLENVU
| International Patents: | 116 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PLENVU |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PLENVU |
| What excipients (inactive ingredients) are in PLENVU? | PLENVU excipients list |
| DailyMed Link: | PLENVU at DailyMed |
Recent Clinical Trials for PLENVU
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | Phase 4 |
| Hospital Clinic of Barcelona | Phase 4 |
| Casen Recordati S.L. | Phase 4 |
Paragraph IV (Patent) Challenges for PLENVU
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PLENVU | FOR SOLUTION;ORAL | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | 209381 | 2018-12-06 |
US Patents and Regulatory Information for PLENVU
International Patents for PLENVU
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| India | 1704DEN2015 | Start Trial |
| Hungary | E043605 | Start Trial |
| Australia | 2015228962 | Start Trial |
| Japan | 2017507965 | Start Trial |
| Japan | 6297334 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
