Last Updated: October 4, 2026

VISICOL Drug Patent Profile


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  • What is the 5 year forecast for VISICOL?
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Summary for VISICOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 1
DailyMed Link:VISICOL at DailyMed
Recent Clinical Trials for VISICOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Braintree LaboratoriesPhase 3

See all VISICOL clinical trials

US Patents and Regulatory Information for VISICOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms VISICOL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021097-001 Sep 21, 2000 DISCN No 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

International Patents for VISICOL

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

Country Patent Number Title Estimated Expiration
Austria 235894 ⤷  Start Trial
Canada 2241445 PREPARATIONS PURGATIVES NON AQUEUSES POUR LE COLON (NON-AQUEOUS COLONIC PURGATIVE FORMULATIONS) ⤷  Start Trial
Germany 69627170 ⤷  Start Trial
Denmark 0858326 ⤷  Start Trial
European Patent Office 0858326 PREPARATIONS PURGATIVES NON AQUEUSES POUR LE COLON (NON-AQUEOUS COLONIC PURGATIVE FORMULATIONS) ⤷  Start Trial
Spain 2196149 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 9741838 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VISICOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0957929 06C0021 France ⤷  Start Trial PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511 SPC/GB08/036 United Kingdom ⤷  Start Trial PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823 1490064-1 Sweden ⤷  Start Trial PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340 99C0005 Belgium ⤷  Start Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687 SPC/GB98/030 United Kingdom ⤷  Start Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0290047 SPC/GB97/078 United Kingdom ⤷  Start Trial PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
0290047 97C0108 Belgium ⤷  Start Trial PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: July 22, 2026

VISICOL market dynamics and financial trajectory: sales, pricing, competitive pressure, and exclusivity outlook

VISICOL is a brand name used for prescription bowel-cleansing products containing sodium picosulfate and magnesium citrate (often marketed as a “bowel preparation” kit). Public financial disclosure is limited because VISICOL is typically a branded product within a niche GI pre-procedure market rather than a large, widely reported global franchise. Market dynamics are driven by (1) procedural volumes for colonoscopy and endoscopy, (2) payer and hospital formulary preferences for bowel prep kits, (3) competitive substitution among similarly positioned OTC and prescription regimens, and (4) regulatory/pharmacovigilance and labeling updates that shift prescriber and pharmacy behavior.

Below is the market and financial trajectory framework for VISICOL, anchored to how bowel-prep brands typically transact in the US and other regulated markets, and mapped to the levers that determine revenue durability: exclusivity, generic/biosimilar substitution risk, buy-and-bill versus pharmacy reimbursement patterns, contract pricing, and channel mix.


What drives VISICOL bowel prep demand and how do colonoscopy procedure trends affect sales?

Core demand signals for bowel preparation

Bowel cleansing demand tracks procedural volume and scheduling intensity:

  • Colonoscopy incidence and screening rates influence annual demand.
  • Geographic variation in screening and reimbursement changes baseline prescription and kit utilization.
  • Operating throughput in outpatient endoscopy centers affects conversion of “scheduled prep” into completed procedures.

Where VISICOL revenue tends to be concentrated

Bowel prep brands generally concentrate in:

  • GI and endoscopy specialty prescribing channels (clinic-based prescribing, hospital outpatient).
  • Hospital outpatient pharmacies and wholesaler distribution depending on the reimbursement model in each country.
  • Pack-based purchasing where procurement managers optimize total acquisition cost rather than unit price.

Payer and formulary effects

The most material market lever is whether VISICOL remains:

  • Preferred on commercial plans and hospital formularies, or
  • Non-preferred with higher patient cost-sharing that depresses adherence and drop-through.

In bowel prep, formulary “tiering” impacts completion rates. Non-preferred options often lose market share not only on price but on patient adherence and perceived tolerability.


How has VISICOL pricing and contracting typically evolved in the bowel prep market?

Net price pressure mechanics

For branded bowel prep kits, net pricing typically compresses through:

  • Mandatory rebates/discounts under managed care contracting.
  • Hospital group purchasing organization (GPO) leverage and multi-source bidding.
  • Switching to lower-cost alternatives once a generic or lower-priced kit is accepted on formularies.

Switching triggers

Switching away from a branded kit usually occurs after one or more of:

  • A generic sodium picosulfate/magnesium citrate kit enters widely.
  • A competitor with a more favorable tolerability profile gains guideline alignment.
  • A payer moves the regimen from a lower tier to a higher tier.

When does VISICOL lose exclusivity and what are the generic entry risks?

Exclusivity reality for older GI brands

Bowel-cleansing products based on well-known active ingredients typically face exclusivity constraints:

  • Composition-of-matter exclusivity is usually not the long tail driver because the actives are established.
  • Revenue durability is commonly tied to:
    • Formulation/process patents (if any remain),
    • Packaging/configuration and specific kit presentation, and
    • Method-of-use or instruction/patient-experience claims (if protected).

Generic risk model

Generic risk is usually highest when:

  • Orange Book listings (or local equivalent) show near-term expirations for listed patents,
  • Manufacturing process differences are not protected, and
  • The product’s kit format does not have protectable proprietary elements.

Paragraph IV / litigation pathway

If a generic applicant seeks to launch before patent expiry, the economic outcome depends on:

  • Whether the relevant patents are listed for the exact dosage form/strength,
  • The scope of exclusivity (method-of-use vs formulation vs packaging),
  • The likelihood of settlement versus sustained litigation.

What is the Orange Book status of VISICOL, and which patents are listed for exclusivity?

VISICOL’s Orange Book (FDA US) coverage depends on whether the marketed strengths/dosage forms have listed patents. Without verified listing data for each strength and applicant, a precise Orange Book patent-by-patent mapping cannot be provided here.

For bowel prep products, the typical pattern is:

  • If patents are listed, they are often limited to formulation/process/patient-instruction method claims.
  • Once listed patents expire, generic kit launch becomes the dominant revenue disruptor.

How many patents protect VISICOL formulations and delivery/kit presentation?

Typical protection structure in bowel prep

For sodium picosulfate/magnesium citrate kit products, protection usually clusters into:

  • Formulation (tablet/powder combinations, dissolution characteristics, excipients),
  • Manufacturing process (mixing, granulation, stability-related parameters),
  • Kit assembly (components and instructions),
  • Method-of-use (timing, dosing schedule, patient guidance claims).

What matters commercially

The number of patents matters less than:

  • Whether patents cover the exact product configuration used today,
  • Whether they block generic manufacturing without design-arounds,
  • Whether they include regulatory exclusivity hooks via listed patents.

What patent litigation affects VISICOL, and how do settlements typically change launch timing?

Litigation as a launch-timing determinant

In GI brands, litigation effects show up in:

  • Stay of FDA approval (automatic or by settlement),
  • Temporary loss of exclusivity if courts invalidate key claims,
  • Design-around approvals if generic sponsors can avoid claim scope.

Settlement patterns

Settlements in bowel-prep are often structured as:

  • Agreed launch windows for generics, or
  • Revenue sharing and stipulated injunction triggers tied to specific formulations.

How does VISICOL compare with competing bowel prep kits on adherence, tolerability, and payer preference?

Competitive set

VISICOL’s competitive pressure is usually “within class” and “adjacent class”:

  • Other prescription bowel preps for colonoscopy,
  • OTC and low-cost regimens positioned for payer and patient affordability.

What wins market share

Market share tends to shift when competitors deliver:

  • Better tolerability (less nausea/vomiting),
  • Clearer dosing instructions that increase completion,
  • Contract pricing advantages (lower net cost).

Hospital formulary influence

Endoscopy centers often standardize bowel prep selection:

  • Standardization favors kits with stable supply, consistent dosing, and favorable total cost.
  • Switchovers are usually annual procurement cycles or when supply/pricing changes.

What does VISICOL revenue concentration look like by channel and geography?

Channel

Common channel allocations for bowel prep brands:

  • Wholesaler distribution into hospital outpatient and GI clinics.
  • Retail pharmacy for outpatient prescriptions where allowed.

Channel mix affects:

  • Reported revenue volatility (hospital contracting changes slower than retail),
  • Net price outcomes (hospital contracts can compress faster once multi-source becomes accepted).

Geography

In international markets, financial trajectory typically hinges on:

  • Whether the product is authorized as a local brand versus an import,
  • National reimbursement rates and reimbursement category placement,
  • Local generic substitution speed and tendering frameworks.

How strong is the commercial outlook for VISICOL as generics expand?

Base case dynamic

For GI bowel preps with older actives, the standard trajectory is:

  • Branded sales peak or stabilize while formulary position remains favorable,
  • Then decline as generic kits capture standardization tenders and payer preferred lists.

What can extend the tail

VISICOL can maintain revenue longer if it retains:

  • A preferred position on major formularies,
  • Contracts that delay competitive switching,
  • Differentiation that affects adherence (patient completion outcomes),
  • Residual patent or exclusivity protection for the exact kit configuration.

Key financial trajectory framework for VISICOL (how to model revenue under multi-source risk)

Because VISICOL’s granular sales figures are not provided in the prompt and can vary across markets and reporting regimes, the actionable path is modeling revenue with bowel-prep-specific drivers:

Revenue lever Branded exposure Generic pressure vector Practical impact
Net price Rebates/contracting reduce unit margin Multi-source bidding compresses net price Margin erosion accelerates after formulary switch
Volume Depends on procedural volumes and completion rates Generic availability increases prescribing substitution Volume declines once switched as default prep
Channel mix Hospital vs retail changes stability Hospital standardization quickly reshapes mix Hospital contracts can cause step-changes in sales
Patient adherence Differentiates brand selection Cheap alternatives can reduce completion if instructions differ Lower adherence can reduce repeat use
Litigation/period of protection Delays generic launch Patent expiry and design-arounds accelerate entry Revenue step-down follows launch timing

Key Takeaways

  • VISICOL demand tracks colonoscopy/endoscopy procedural volumes and payer/hospital formulary preference.
  • Financial trajectory in bowel prep products is usually dominated by net price contracting and multi-source substitution rather than long-lived global exclusivity.
  • Generic entry timing, driven by patent/Orange Book status and litigation outcomes where applicable, is the primary determinant of revenue step-down.
  • Competitive wins typically come from tolerability/adherence performance plus lower net acquisition costs through hospital and payer contracting.

FAQs

1) What happens to VISICOL sales when a generic sodium picosulfate/magnesium citrate kit becomes preferred?

Sales typically decline due to formulary switch and prescriber standardization, with faster reductions in hospital outpatient procurement than in retail.

2) Does VISICOL revenue depend more on pricing or on procedural volumes?

Pricing dominates once multi-source options are available. Procedural volumes set the ceiling; net price and share determine realized revenue.

3) Are bowel prep branded products usually protected by composition-of-matter patents?

Often not in a way that drives long duration. Protection commonly concentrates in formulation/process/kit and, less frequently, method-of-use elements.

4) How do hospital contracts change the timeline of generic impact for VISICOL?

Hospital tender cycles can create delayed but abrupt sales drops when the kit becomes non-preferred or replaced in standard protocols.

5) What labeling or tolerability changes most affect bowel prep adoption?

Changes that affect perceived tolerability, adherence instructions, or safety communications can shift prescribing and adherence, which can change market share even when pricing is similar.


References (APA)

  1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
  2. FDA. (n.d.). Drug Trials Snapshots. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
  3. IQVIA. (n.d.). Oncology and GI market access and pharmacy contracting insights (industry reporting). IQVIA.

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