VISICOL Drug Patent Profile

When do Visicol patents expire, and when can generic versions of Visicol launch?

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

The generic ingredient in VISICOL is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.

Summary for VISICOL

US Patents:	0
Applicants:	1
NDAs:	1

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

International Patents for VISICOL

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

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

Supplementary Protection Certificates for VISICOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1856135	CR 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
2666774	CA 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217

VISICOL (Cisapride) Investment Scenario and Fundamentals Analysis

Last updated: April 23, 2026

What is VISICOL and how is it positioned in the market?

VISICOL is a brand name for cisapride, a prokinetic/antiemetic marketed for gastrointestinal motility disorders. In most major markets, cisapride’s commercial life has been constrained by safety-driven regulatory actions that narrowed or eliminated routine access.

Core market implication: the addressable market for a cisapride brand is structurally limited versus earlier lifecycle stages, because prescribability and distribution were curtailed by regulators over safety concerns.

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What is the regulatory and safety context that defines long-term value?

Cisapride has a well-documented association with QT interval prolongation and torsades de pointes, driven by effects on cardiac repolarization. This translated into regulatory actions that materially reduced mainstream availability.

Key policy endpoint (EU):

• European Medicines Agency (EMA): cisapride product availability was suspended in Europe via restrictive measures following safety review outcomes. (European public health guidance and EMA communications reflect this outcome.) [1]

Key policy endpoint (US):

• US FDA: cisapride faced market restriction and ultimately withdrawal of routine marketing authorization; access moved to limited pathways with strong safety framing. [2]

Investment consequence: VISICOL-related revenue potential is tied less to marketing execution and more to whether any remaining jurisdictions maintain legal pathways for cisapride prescriptions (typically narrow, physician-controlled, and limited-use). That profile drives low visibility for new entrants and compresses upside for brand-extension strategies.

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What is the current fundamentals profile (demand, pricing, and durability)?

Because cisapride is primarily an established, safety-constrained product class rather than an innovation pipeline, fundamentals cluster around three variables: surviving prescriber demand, restricted supply/distribution, and pricing under constrained demand.

Demand durability drivers

• Chronic GI indications with motility impairment: clinicians may still seek a historical option when alternatives fail, but use is usually constrained.
• Physician governance: safety rules increase monitoring burden (ECG/QT awareness), reducing routine adoption.
• Competition from safer prokinetics: in markets where cisapride use is restricted, prescribers shift to alternatives.

Pricing and reimbursement constraints

• In restricted regimes, pricing tends to be capped by:
  • limited patient volume
  • reimbursement friction
  • supply risks (fewer manufacturing sources)

Supply and distribution risk

• Safety-driven withdrawal dynamics typically reduce the number of actively marketed channels over time. That raises:
  • stocking discontinuity risk
  • price volatility in remaining channels

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What does the patent landscape imply for VISICOL investors?

Cisapride is a legacy molecule; VISICOL is a brand. For investment decisioning, the differentiator is whether any secondary protections (polymorphs, formulations, dosage forms, or methods of use) exist in the target geography.

Practical patent takeaway

• For an older molecule like cisapride, core composition-of-matter exclusivity is usually expired in major jurisdictions.
• Value tends to come from:
  • remaining regulatory exclusivity (if any)
  • brand-level residual market presence
  • manufacturing/distribution control
  • any formulation/regulatory data protections (rare for legacy brands)

Investment consequence: VISICOL’s economic model is usually not “patent runway-led.” It is a restricted-market continuation model.

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What are the key commercial levers and their impact on returns?

1) Jurisdiction-specific access

• Returns depend on whether VISICOL remains available under local prescribing rules.
• If remaining access is limited to specific indications, returns track those indications, not total GI market volume.

2) Safety monitoring logistics

• Any brand that is used under risk controls faces higher friction:
  • prescriber adherence requirements
  • patient monitoring workflow
• This caps growth even where some demand remains.

3) Substitution pressure

• Safer prokinetics and newer GI therapeutics typically take share when available.
• For a safety-constrained molecule, therapeutic switching is a structural risk, not a marketing risk.

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How does a competitor-and-alternative landscape shape upside?

For a prokinetic class position, cisapride competes with therapies aimed at GI motility and nausea that generally carry less torsades risk profiles. The presence of alternatives directly limits patient capture and reinforces restricted use.

Fundamentals impact: even if VISICOL remains marketed in some markets, growth is structurally capped by substitution and prescriber preference drift.

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What is the investment scenario by archetype?

Archetype A: “Residual brand value” (lowest volatility, low upside)

• Assumes VISICOL remains on formulary lists in a shrinking niche.
• Revenue is stable or mildly declining.
• Upside is tied to maintaining supply reliability and meeting safety protocol adherence.

Best fit: value-oriented investors expecting limited demand but controlled discontinuity risk.

Archetype B: “Regulatory reactivation” (high optionality, low base case)

• Assumes a jurisdiction reverses constraints or introduces renewed pathways.
• Base case remains unfavorable due to the strong torsades risk record.

Best fit: event-driven investors underwriting scenario probability.

Archetype C: “Portfolio manufacturing/distribution consolidation” (operations-led)

• If fewer suppliers remain, distribution scale and manufacturing cost control can protect margins even as demand declines.

Best fit: operational investors focused on throughput, quality systems, and continuity planning.

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What are the principal risks to underwriting VISICOL?

1. Regulatory tightening or suspension in any remaining jurisdiction.
2. Therapeutic substitution as prescribers switch to alternatives.
3. Supply and continuity risk if manufacturing economics degrade.
4. Safety signal reinforcement from post-marketing data and pharmacovigilance actions.
5. Reimbursement friction driven by low utilization and guideline displacement.

These risks primarily act as downside multipliers, not just timeline shifts.

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Investment decision frame: where should capital focus?

Underwriting priorities

• Confirm remaining legal access at the country level (not molecule-level).
• Map remaining indication scope and prescriber governance requirements.
• Assess supply chain stability (manufacturing and distribution continuity).
• Quantify competitive substitution in the exact clinical subsegments where VISICOL is still used.

Return drivers

• Revenue durability in restricted niches.
• Margin through supply continuity and procurement scale.
• Cost discipline and pharmacovigilance compliance execution.

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Key Takeaways

• VISICOL is a brand for cisapride, a legacy prokinetic whose commercial footprint is constrained by QT prolongation and torsades risk and subsequent major regulatory restrictions.
• The investment case is usually not patent-led; it is jurisdiction- and access-led, with upside limited by substitution and safety-driven prescribing friction.
• Best-return opportunities typically come from residual niche execution or operations-led consolidation rather than growth-stage expansion.

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FAQs

Is VISICOL expected to generate innovation-style growth returns?

No. CISAPIDE (VISICOL) is a legacy safety-constrained molecule; growth is constrained by restricted access and substitution.

What primarily determines VISICOL’s addressable market?

Country-level prescribing permissions and remaining indication scope, not broader GI market trends.

How does safety monitoring affect commercial performance?

Safety governance increases prescriber workflow friction, which reduces routine adoption and caps demand expansion.

Does patent life materially drive VISICOL valuation?

Typically not for cisapride brands; value more often depends on residual market access and operational continuity.

What is the biggest downside risk for investors?

Regulatory tightening or suspension in remaining markets, combined with ongoing substitution away from cisapride.

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References

[1] European Medicines Agency (EMA). Public assessment and safety communications regarding cisapride market restrictions in the European Union.
[2] U.S. Food and Drug Administration (FDA). Regulatory actions on cisapride safety and market authorization limitations in the United States.