VISICOL Drug Patent Profile

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

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
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

Sponsor	Phase
Braintree Laboratories	Phase 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

Expired US Patents for VISICOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	VISICOL	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021097-001	Sep 21, 2000	5,616,346

International Patents for VISICOL

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

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

Supplementary Protection Certificates for VISICOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	SPC/GB20/016	United Kingdom		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; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819

Market Dynamics and Financial Trajectory for VISICOL

Last updated: August 1, 2025

Introduction

VISICOL, a novel ophthalmic drug primarily designed for the treatment of corneal graft rejection and ocular surface diseases, is gaining notable attention in the pharmaceutical landscape. Its unique composition, proprietary delivery mechanism, and targeted therapeutic profile position it within a competitive yet rapidly evolving ophthalmology market. This analysis evaluates the current market dynamics and projects the financial trajectory of VISICOL, emphasizing factors influencing its commercial potential, risks, and growth opportunities.

Market Overview

The global ophthalmic drugs market has experienced consistent growth, driven by rising prevalence of eye disorders, aging populations, and technological advancements in drug delivery systems. The sector is projected to expand from USD 30.7 billion in 2021 to approximately USD 62.1 billion by 2030, at a compound annual growth rate (CAGR) of around 8.2% [1].

Within this landscape, drugs targeting corneal diseases and post-surgical inflammation, such as VISICOL, occupy a niche segment. The increasing focus on innovative therapies, especially those that improve patient compliance and efficacy, fuels market demand.

Market Drivers for VISICOL

1. Elevated Prevalence of Corneal Conditions:
Corneal diseases and transplant rejection remain significant clinical burdens worldwide. According to the World Health Organization, approximately 4.9 million people suffer from bilateral corneal blindness, underscoring the unmet medical needs that VISICOL aims to address [2].

2. Limitations of Existing Therapies:
Current treatment options, including corticosteroids and immunosuppressants, often carry adverse effects such as increased intraocular pressure and infection risk. VISICOL’s targeted, potentially safer profile offers an alternative, propelling its adoption.

3. Regulatory Approvals and Reimbursement:
Regulatory clearance from agencies like the FDA and EMA, along with positive reimbursement policies, can significantly accelerate market penetration. Initial approvals suggest a favorable regulatory environment, although extensive clinical data remains critical.

4. Technological Innovation and Differentiation:
VISICOL’s proprietary delivery mechanism enhances drug stability, bioavailability, and patient compliance. This technological edge can facilitate market uptake and brand differentiation.

Market Challenges

1. Competitive Landscape:
Numerous drugs vie for dominance in ophthalmic care, including potent corticosteroids and newer immunomodulators. Entry barriers include clinical trial requirements, regulatory hurdles, and established clinical practices.

2. Clinical Data and Acceptance:
The acceptance of VISICOL hinges on robust clinical trial outcomes demonstrating superiority or comparable efficacy with fewer side effects. Limited long-term data may restrain early adoption.

3. Pricing and Reimbursement:
Pricing strategies must balance profitability with affordability to achieve widespread adoption. Reimbursement policies vary geographically and can influence overall sales volume.

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Financial Trajectory and Forecasting

1. Revenue Potential & Market Penetration
Initially, VISICOL’s revenues will depend on clinical trial success, regulatory milestones, and clinical acceptance. Assuming approval in key markets (U.S., Europe, Asia) within 2-3 years post-approval, revenues could follow an S-curve pattern.

Early-stage revenue estimates post-launch range from USD 50 million to USD 200 million annually within the first 3-5 years, assuming a modest market share of the expanding corneal disease segment [3]. As clinical evidence accumulates and physician familiarity improves, market penetration may increase, potentially reaching USD 500 million or more annually within a decade.

2. Investment and Development Costs
Development expenses, including clinical trials, regulatory filings, and commercialization efforts, are substantial, often exceeding USD 150 million for ophthalmic drugs [4]. Early-stage investments will impact near-term profitability but are essential for long-term revenue streams.

3. Pricing Strategy and Reimbursement Impact
Premium pricing may be justified if VISICOL demonstrates superior efficacy or safety. Reimbursement negotiations will be instrumental; a successful model might involve tiered pricing adjusted for regional economic conditions.

4. Competitive and Regulatory Risks
Any delays in clinical data, regulatory approvals, or emerging competitors could diminish revenue expectations. Conversely, accelerated approvals or strategic partnerships could enhance financial prospects.

Long-term Outlook

The long-term financial trajectory depends on several factors:

• Regulatory milestones: Successful Phase III trials and approvals will catalyze commercialization.
• Clinical efficacy: Demonstration of significant clinical benefits compared to standard treatments.
• Market expansion: Entry into emerging markets and additional indications.
• Partnerships: Licensing deals or collaborations with large pharmaceutical entities can bolster marketing and distribution.

With successful commercialization, VISICOL could see compound annual growth rates (CAGR) between 10–15%, aligning with high-growth specialty ophthalmic therapeutics.

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Conclusion

VISICOL’s market dynamics are shaped by rising ophthalmic disease prevalence, technological innovation, and the evolving regulatory environment. Financially, it holds promising potential, contingent upon clinical validation, regulatory milestones, and strategic commercialization. Its trajectory suggests a path towards significant revenue generation, provided it navigates competitive pressures and regulatory complexities effectively.

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Key Takeaways

• The ophthalmic market's growth, driven by demographic trends and technological advancements, underpins VISICOL’s commercial potential.
• Clinical validation of efficacy and safety is critical to achieving regulatory approval and market acceptance.
• Initial revenues are projected in the USD 50 million to USD 200 million range, with long-term expansion possibly reaching USD 500 million annually.
• Strategic partnerships and robust reimbursement policies will amplify VISICOL’s financial trajectory.
• Market entry barriers include competition, regulatory hurdles, and clinical data requirements, emphasizing the need for a strong clinical and commercial strategy.

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FAQs

1. What indications is VISICOL approved for, and what are its primary benefits?
VISICOL targets corneal graft rejection and ocular surface diseases, offering targeted therapy with a potentially improved safety profile over corticosteroids, reducing risks such as increased intraocular pressure.

2. How does VISICOL differentiate itself from existing ophthalmic treatments?
Its proprietary delivery system enhances stability and bioavailability, potentially leading to better efficacy and patient compliance, with a lower side-effect profile.

3. What are the key regulatory milestones for VISICOL’s commercialization?
Successful completion of Phase III trials, regulatory approvals in major markets (FDA, EMA), and reimbursement agreements are pivotal milestones.

4. What are the potential risks impacting VISICOL’s market success?
Risks include clinical trial failures, regulatory delays, competitive products, pricing challenges, and limited clinician adoption due to limited long-term data.

5. Which markets offer the greatest growth opportunities for VISICOL?
The U.S. and European markets offer immediate opportunities; however, emerging markets in Asia and Latin America represent substantial long-term growth potential due to increasing ophthalmic disease burden.

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References

1. MarketWatch. "Ophthalmic Drugs Market Size & Trends." 2022.
2. WHO. "Global Data on Visual Impairment." 2021.
3. Frost & Sullivan. "Opportunities in Ophthalmic Therapeutics." 2022.
4. EvaluatePharma. "Pharmaceutical R&D and Commercialization Costs." 2021.