MOVIPREP Drug Patent Profile

Which patents cover Moviprep, and what generic alternatives are available?

Moviprep is a drug marketed by Salix Pharms and is included in one NDA.

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. 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.

Summary for MOVIPREP

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVIPREP

Paragraph IV (Patent) Challenges for MOVIPREP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVIPREP	For Oral Solution	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch	021881	1	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

International Patents for MOVIPREP

See the table below for patents covering MOVIPREP around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	404223
Australia	2003274377	COLON CLEANSING COMPOSITIONS
Australia	2008100865	Colon cleansing compositions
Australia	2009227838	Colon cleansing compositions
Canada	2502103	COMPOSITIONS DE NETTOYAGE DU COLON (COLON CLEANSING COMPOSITIONS)
Canada	2672427	COMPOSITIONS DE NETTOYAGE DU COLON (COLON CLEANSING COMPOSITIONS)
China	101897721	Colon cleansing compositions

Supplementary Protection Certificates for MOVIPREP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
3141251	132021000000044	Italy		PRODUCT NAME: UN PRODOTTO MEDICINALE COSTITUITO DA UNA COMBINAZIONE DI UNA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E UNA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA, LA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, SOLFATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO E LA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, ACIDO ASCORBICO, ASCORBATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO.(PLENVU); AUTHORISATION NUMBER(S) AND DATE(S): IS/1/17/083/01, 20171016;045671017, 045671029, 045671031, 045671043, 045671056, 20171213
3141251	C202130017	Spain		PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016

MOVIPREP (sodium picosulfate, magnesium oxide, citric acid) Investment Scenario and Patent/FDA Fundamentals Analysis

Last updated: July 30, 2026

MOVIPREP is a branded US bowel-cleansing product with limited near-term generic leverage risk because it is not a large, high-volume blockbuster and faces typical, product-specific reformulation and substitution frictions. The investment case is driven less by patent scarcity than by (1) Orange Book exclusivity and listed patents for the specific listed NDA, (2) FDA labeling and substitution behavior in bowel-prep formularies, and (3) competitive intensity from both lower-cost generics and alternate regimens (split-dose PEG-electrolyte and other stimulant/combination bowel-prep kits).

What is MOVIPREP and how does it compete in bowel prep?

MOVIPREP is an oral bowel-cleansing medicine used for bowel preparation prior to colonoscopy. The active ingredient combination is sodium picosulfate, magnesium oxide, and citric acid (often marketed as a “stimulant + magnesium-based + acid” regimen designed to create an osmotically active cathartic environment). Commercially, bowel-prep share is shaped by:

• dosing convenience and patient tolerability
• split-dose use patterns
• insurance formulary placement
• perceived efficacy and safety in outpatient colonoscopy workflows
• switching behavior among gastroenterology practices

Where does MOVIPREP sit vs PEG-electrolyte, sulfate, and other kits?

• PEG-electrolyte products dominate many US bowel-prep pathways due to established endoscopy standardization and payer comfort with dosing and tolerability.
• MOVIPREP’s role is typically as an alternative regimen where clinicians or payers favor smaller-volume liquids or specific safety profiles.
• Competitive substitutions often occur at the level of “bowel prep kit class” rather than strict API-level substitution, so branded differentiation can persist even after generic availability.

What patents protect MOVIPREP in the US and how strong is the estate?

This section cannot be completed to Bloomberg-grade precision without the MOVIPREP-specific US patent estate and Orange Book listing data (NDA number, listed patent numbers, expiration dates, and exclusivity codes). The result must be accurate and complete to support investment and litigation-risk conclusions, and the required listing-level facts are not provided.

What would the patent estate typically include for bowel-cleansing kits?

A bowel-prep kit like MOVIPREP can have patent coverage spanning:

• composition of matter for the fixed-dose combination and specific ratios
• formulation patents (particle size, granulation, stabilization, moisture control)
• manufacturing process patents (dry blending, encapsulation, packaging control)
• method-of-use patents (colonoscopy preparation timing, split-dose regimens)
• polymorph/crystal form or solid-state control patents (less common for kit powders but present in some delivery systems)
• package and kit-device integration (desiccant, measuring system, kit assembly)

How does patent strength translate to investment risk?

Investment risk for MOVIPREP generally comes from:

• early generic entry if an ANDA is approved to a listed formulation patent or if exclusivity is near expiry
• settlement dynamics that can delay generic launch even after patent expiry
• payer substitution leading to volume erosion if generic or AB-rated alternatives achieve preferred status

What is the Orange Book status of MOVIPREP and which patents are listed for the NDA?

This section cannot be produced without the specific Orange Book listing for the MOVIPREP NDA (listed patents, patent types, expiration dates, and exclusivity blocks).

What is the Orange Book-driven decision framework for investors?

• Identify all listed patents tied to the active ingredient(s) and dosage form(s).
• Track which patents expire first and whether any exclusivity (3-year/5-year/7-year, pediatric, etc.) extends effective market exclusivity.
• Determine whether any listed patents are susceptible to Paragraph IV challenges and whether the NDA has a history of settlements.

When does MOVIPREP lose exclusivity in the US?

This section cannot be completed without Orange Book expiration dates and exclusivity end-dates for the specific MOVIPREP NDA listing. Investors need exact end points to model generic-entry probability.

How to model “effective exclusivity” for a bowel-prep kit

Effective exclusivity for MOVIPREP is the later of:

• the last listed patent expiration date for the marketed strength and dosage form
• any relevant FDA exclusivity periods tied to the NDA or supplemental approvals
• pediatric exclusivity extensions if applicable
• any settlement-triggered “stay” or delayed launch timelines that follow Paragraph IV litigation

Which companies are challenging MOVIPREP with Paragraph IV ANDAs?

This section cannot be completed without court-docket-level Paragraph IV filings and the ANDA sponsor names for MOVIPREP. Litigation details are required to quantify settlement likelihood and launch scheduling.

What investors need from Paragraph IV disputes

• Paragraph IV notice date, ANDA number, and the patent(s) asserted
• filer identity and prior ANDA behavior (launch history)
• claim construction outcomes, final judgment dates, and any Federal Circuit posture
• settlement terms if present (trigger dates, launch conditions, co-marketing royalties, or supply allocations)

What generic entry risks exist for MOVIPREP?

This section cannot be produced without the MOVIPREP Orange Book listing and any known ANDA activity.

Generic entry risk drivers for MOVIPREP

• first generic’s ability to demonstrate bioequivalence for the kit regimen and dosage form
• formulation/packaging switching costs for patients and practices
• the payer’s willingness to switch and the relative price spread
• potential “at-risk” launch timing versus patent stays or injunction risk

How does MOVIPREP compare with competing bowel prep products on IP and regulatory status?

This section requires a product-by-product comparison table grounded in Orange Book status and FDA approvals for each comparator, which is not available here.

Typical comparator set investors model

• PEG-based split-dose regimens (large formulary presence)
• sulfate-based kits and other stimulant-mix regimens
• lower-volume formulations where available
• prescription vs OTC-adjacent alternatives (where relevant)

What is the FDA regulatory path for MOVIPREP and what does it mean for follow-on products?

This section cannot be completed without MOVIPREP NDA labeling details, approval history, supplement history, and current FDA status.

Investor implications of FDA status

• Changes to labeling claims can prompt new exclusivity questions or trigger new patent coverages in supplements.
• Manufacturing site updates and quality system compliance can create operational risk even if IP risk is low.
• Pediatric labeling or regimen instructions can affect perceived clinical substitution and thus revenue trajectory.

What formulation patents or method-of-use patents cover MOVIPREP?

This section cannot be completed without the MOVIPREP listed patent claims and patent types from the Orange Book.

Typical claim themes to verify in litigation or freedom-to-operate

• method claims on timing relative to procedure and diet restrictions
• dosing schedules aligned with split-dose bowel cleansing protocols
• formulation claims tied to stability under humidity and packaging

What licensing deals and settlement agreements matter for MOVIPREP commercialization?

This section cannot be completed without known settlement docket data and/or licensor-announcement records tied to MOVIPREP ANDA challenges.

What settlement terms investors watch in bowel prep

• launch dates and “carve-out” products
• royalties or co-promotion obligations
• supply agreements or exclusivity-like market allocation
• mutual covenant-not-to-sue scope

How does MOVIPREP’ revenue exposure map to volume, pricing, and payer dynamics?

Because MOVIPREP is not specified with disclosed financials in the prompt, this section cannot include hard revenue exposure metrics without creating unverifiable projections.

High-information, non-financial drivers investors should still model

• endoscopy procedure volumes by geography and site-of-care mix
• formulary status and step therapy placement
• utilization controls tied to bowel prep quality and repeat procedures
• brand switch friction: patient intolerance, adherence issues, and clinic protocol lock-in

Investment scenario: base case, downside, and upside framework (IP + market structure)

Without the MOVIPREP Orange Book and litigation dataset, only a structural framework can be stated, not a numeric scenario. The investment case for MOVIPREP is best built around:

• whether any listed patent barrier remains for the specific kit strength/formulation
• whether generic entry is delayed or blocked by active litigation
• whether payer substitution after generic entry materially compresses price and share

Downside scenario mechanics

• effective exclusivity ends earlier than expected due to patent expiration cascade
• a fast-moving first filer launches at-risk (or within stay windows)
• formulary switches shift quickly to the cheapest AB-rated kit

Upside scenario mechanics

• patent estate includes formulation or method patents that are harder to design around
• settlements push generic entry dates beyond effective exclusivity
• MOVIPREP retains formulary position due to protocol fit or tolerability perception

Key Takeaways

• MOVIPREP’s investment fundamentals hinge on Orange Book-listed patents and exclusivity end-dates for the exact MOVIPREP NDA listing; without that listing data, IP and generic-entry timing cannot be quantified.
• Competitive risk is meaningful in US bowel prep because patient and payer substitution is common, but brand-to-generic transition speed depends on kit-level switching behavior and local formulary practices.
• The most decision-relevant diligence items are: listed patent expiration sequencing, any Paragraph IV ANDA challenges, settlement terms, and active litigation status tied to the specific MOVIPREP patents.

FAQs

1. How do I find MOVIPREP’s exact FDA NDA number and associated Orange Book listings?
2. Which MOVIPREP patent types (composition, formulation, method-of-use) usually matter most for ANDA design-around strategies?
3. What evidence supports whether a generic bowel-prep kit will substitute quickly after approval?
4. How does split-dose colonoscopy labeling affect generic switching and payer formulary decisions?
5. What litigation milestones most influence generic launch timing after a Paragraph IV notice for bowel-cleansing drugs?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via Orange Book database).
2. U.S. Food and Drug Administration. FDA Drug Approval Reports and NDA approval history records. (Accessed via FDA databases).