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MOVIPREP Drug Profile
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See Plans and PricingWhich patents cover Moviprep, and when can generic versions of Moviprep launch?
Moviprep is a drug marketed by Salix Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-four patent family members in twenty-two countries.
The generic ingredient in MOVIPREP is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Two 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 Moviprep
Annual sales in 2017 were $8mm indicating the motivation for generic entry (peak sales were $33mm in 2009).
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 MOVIPREP
| International Patents: | 54 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 33 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MOVIPREP |
| Drug Sales Revenues: | Drug sales revenues for MOVIPREP |
| DailyMed Link: | MOVIPREP at DailyMed |
Recent Clinical Trials for MOVIPREP
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Russian Society of Colorectal Surgeons | N/A |
| Zealand University Hospital | Phase 1 |
| University of Copenhagen | Phase 1 |
Paragraph IV (Patent) Challenges for MOVIPREP
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MOVIPREP | FOR SOLUTION;ORAL | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | 021881 | 2007-11-27 |
US Patents and Regulatory Information for MOVIPREP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salix Pharms | MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881-001 | Aug 2, 2006 | AA | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Salix Pharms | MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881-001 | Aug 2, 2006 | AA | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for MOVIPREP
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1126678 | Start Trial |
| Slovenia | 1567193 | Start Trial |
| Japan | 2012025732 | Start Trial |
| Australia | 2008100865 | Start Trial |
| Germany | 08014286 | Start Trial |
| China | 101897721 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
