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
Austria	235894
European Patent Office	0858326	PREPARATIONS PURGATIVES NON AQUEUSES POUR LE COLON (NON-AQUEOUS COLONIC PURGATIVE FORMULATIONS)
Germany	69627170
Spain	2196149
World Intellectual Property Organization (WIPO)	9741838

Supplementary Protection Certificates for VISICOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2380576	20C1048	France		PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729
1948158	93075	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
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
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625

Market Dynamics and Financial Trajectory for Visicol

Overview of Visicol

Visicol, a purgative medication composed of sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous, is used to clean the colon prior to colonoscopy. Here’s a detailed look at the market dynamics and financial trajectory for Visicol, set against the broader pharmaceutical market context.

Market Context: Pharmaceutical Industry Trends

The U.S. pharmaceutical market is projected to grow significantly, reaching USD 1,093.79 billion by 2033, with a CAGR of 6.15% from 2024 to 2033[1].

Dominant Segments

• The branded segment dominates the market, holding a 68.19% revenue share in 2023.
• The prescription segment accounts for 88.23% of the market revenue in 2023[1].

Growth Drivers

• Biologics and biosimilars are expected to drive significant growth, with the fastest CAGR in the pharmaceutical market. Biosimilars, in particular, offer cost-effective alternatives to biologic medicines, enhancing market competition[1].

Specific Market Dynamics for Visicol

Clinical Efficacy and Safety

Visicol has been shown to be comparable in cleansing efficacy to other commercially available colon cleansing agents, such as polyethylene glycol-salt (PEG-salt) solutions. Clinical trials demonstrated that Visicol Tablets were effective in preparing patients for colonoscopy, although they were associated with higher rates of adverse events like bloating, nausea, and abdominal pain compared to the PEG-salt solution[5].

Market Position

Visicol operates within the gastrointestinal segment of the pharmaceutical market, which, while not the largest segment, is crucial for diagnostic procedures like colonoscopies. The demand for effective colon cleansing agents is steady, driven by the need for accurate diagnostic outcomes.

Competitive Landscape

The market for colon cleansing agents is competitive, with several products available, including PEG-salt solutions like NuLYTELY. Visicol must compete on efficacy, safety, and patient preference to maintain its market share.

Financial Trajectory

Revenue Streams

Visicol generates revenue primarily through prescription sales. Given that the prescription segment dominates the pharmaceutical market, Visicol benefits from this trend. However, the financial performance of Visicol is influenced by several factors:

• Prescription Volume: The number of colonoscopies performed annually drives the demand for Visicol. With an aging population and increased screening recommendations, this demand is likely to remain steady or increase.
• Pricing and Reimbursement: The pricing of Visicol and its reimbursement status under various healthcare plans can significantly impact its revenue. In a market where cost containment measures are increasingly important, the pricing strategy for Visicol must balance profitability with affordability and competitiveness[3].

Growth Projections

While specific financial projections for Visicol are not available, the overall growth trends in the pharmaceutical market suggest that it will benefit from the expanding market size. Here are some broader trends that could influence Visicol’s financial trajectory:

• Total Drug Spending: Total drug spending in the U.S. is projected to grow from $500 billion in 2018 to $863 billion by 2028, with prescription drugs representing a significant portion of this spending[2].
• Segment Growth: The gastrointestinal segment, while not the fastest-growing, is expected to see steady growth driven by the increasing prevalence of gastrointestinal disorders and the need for diagnostic procedures.

Key Challenges and Opportunities

Challenges

• Adverse Events: Visicol is associated with higher rates of adverse events compared to some competitors, which could impact patient and physician preference.
• Competition: The presence of other effective colon cleansing agents poses a significant competitive challenge.
• Regulatory Environment: Changes in regulatory policies, especially those related to drug pricing and reimbursement, can affect Visicol’s market position and revenue.

Opportunities

• Aging Population: An increasing aging population is likely to drive up the demand for colonoscopies, thereby increasing the demand for Visicol.
• Innovative Marketing: Differentiating Visicol through innovative marketing strategies and highlighting its unique benefits could help it gain a competitive edge.
• Expanding Indications: Potential expansion of Visicol’s indications to other gastrointestinal procedures could further boost its revenue.

Key Takeaways

• Market Position: Visicol operates in a competitive market for colon cleansing agents but benefits from the overall growth in the pharmaceutical industry.
• Clinical Efficacy: It has demonstrated comparable efficacy to other products, though with higher adverse event rates.
• Financial Trajectory: The financial performance of Visicol is tied to broader trends in prescription drug spending and the gastrointestinal segment.
• Challenges and Opportunities: The product faces challenges from competition and adverse events but has opportunities for growth driven by demographic changes and potential expansion of indications.

FAQs

Q: What is Visicol used for?

Visicol is used to clean the colon prior to colonoscopy, serving as a purgative medication.

Q: How does Visicol compare to other colon cleansing agents?

Visicol has been shown to be comparable in cleansing efficacy to other commercially available agents like polyethylene glycol-salt (PEG-salt) solutions, though it has higher rates of adverse events.

Q: What are the key drivers of the pharmaceutical market that could impact Visicol?

The key drivers include the growth of biologics and biosimilars, increasing prescription drug spending, and demographic changes such as an aging population.

Q: What challenges does Visicol face in the market?

Visicol faces challenges from competition, higher adverse event rates, and regulatory changes that could affect its pricing and reimbursement.

Q: What opportunities are available for Visicol’s growth?

Opportunities include an increasing aging population driving up demand for colonoscopies, innovative marketing strategies, and potential expansion of indications.

Sources

1. U.S. Pharmaceutical Market Size to Reach USD 1,093.79 Billion By 2033 - Biospace
2. Projections of US Prescription Drug Spending and Key Policy Implications - JAMA Health Forum
3. IQVIA Quarterly Pharmaceutical Market Outlook - IQVIA
4. Antibody Drugs: Technologies and Global Markets - BCC Research
5. Visicol: Package Insert / Prescribing Information - Drugs.com