OSMOPREP Drug Patent Profile

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

Osmoprep is a drug marketed by Salix Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in eleven countries.

The generic ingredient in OSMOPREP 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.

DrugPatentWatch^® Generic Entry Outlook for Osmoprep

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for OSMOPREP

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
Drug Prices:	Drug price information for OSMOPREP
What excipients (inactive ingredients) are in OSMOPREP?	OSMOPREP excipients list
DailyMed Link:	OSMOPREP at DailyMed

See drug prices for OSMOPREP

See drug sales revenues for OSMOPREP

Recent Clinical Trials for OSMOPREP

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4

See all OSMOPREP clinical trials

Paragraph IV (Patent) Challenges for OSMOPREP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OSMOPREP	Tablets	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	1.102 g and 0.398 g	021892	1	2008-04-09

US Patents and Regulatory Information for OSMOPREP

OSMOPREP is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006		DISCN	Yes	No	7,687,075		Y	Y

Expired US Patents for OSMOPREP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006	5,616,346

International Patents for OSMOPREP

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

Country	Patent Number	Title	Estimated Expiration
China	102648980	Colonic purgative composition with soluble binding agent
Germany	69627170
Canada	2814523	COMPOSITION PURGATIVE POUR LE COLON A AGENT DE LIAISON SOLUBLE (COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT)
Canada	2546637	COMPOSITION PURGATIVE POUR LE COLON A AGENT DE LIAISON SOLUBLE (COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT)

Supplementary Protection Certificates for OSMOPREP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OSMOPREP

Last updated: July 28, 2025

Introduction

OSMOPREP, a pharmaceutical compound approved for the treatment of gastrointestinal conditions, exemplifies the evolving landscape of targeted medication development and market positioning within the pharmaceutical industry. As a drug primarily used for bowel preparation, its market dynamics are influenced by factors including regulatory approvals, patent status, competitive landscape, healthcare provider adoption, and patient preferences. Analyzing these components provides insight into its financial trajectory and strategic growth potential.

Pharmaceutical Profile and Regulatory Status

OSMOPREP, developed by Otsuka Pharmaceutical Co., Ltd., is marketed as a low-volume, osmotic bowel cleanser. Its active ingredient typically involves osmotic agents like sodium picosulfate, magnesium oxide, and citrate, which promote bowel cleansing for colonoscopy procedures. Regulatory approvals across major markets such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have positioned OSMOPREP as an alternative to traditional high-volume prep solutions, emphasizing patient tolerability and convenience.

The drug received approval based on clinical trials demonstrating efficacy comparable to existing bowel preparations, with a safety profile deemed acceptable for routine clinical use. Ongoing post-market surveillance continues to monitor safety and efficacy, which influences long-term market acceptance.

Market Drivers

1. Growing Incidence of Colorectal Cancer and Colonoscopy Procedures

The rising incidence of colorectal cancer globally, especially among aging populations, significantly boosts the demand for colonoscopies. As preventive screenings become more routine, the market for bowel preparation agents like OSMOPREP expands proportionally. According to the World Health Organization, colorectal cancer ranks as the third most common cancer worldwide, underscoring the clinical need for effective bowel prep solutions.

2. Patient Preference for Low-Volume Preparations

Traditional bowel prep regimens involve large-volume solutions (typically 4 liters), which often lead to poor patient compliance due to volume-related discomfort. OSMOPREP’s low-volume format enhances patient tolerability, thereby increasing adoption rates among gastroenterologists and patients alike. This innovation provides a competitive advantage, especially in markets with high consumer demand for patient-friendly alternatives.

3. Regulatory and Reimbursement Factors

Regulatory approvals that recognize OSMOPREP as a safe and effective option facilitate its uptake. Furthermore, reimbursement policies from insurers and national health systems influence prescribing habits. In markets where reimbursement is favorable, sales volume increases—highlighting the importance of ongoing engagement with payers.

Competitive Landscape

The bowel preparation market is mature, with key players such as Braintree Laboratories (GoLYTELY, Miralax), and other proprietary formulations. OSMOPREP positions itself within a segment emphasizing low-volume, more tolerable options. Its main competitors include:

• Polyethylene glycol (PEG)-based solutions: e.g., PEG with electrolytes.
• Sodium sulfate-based agents: e.g., OsmoPrep.
• Other novel formulations: emerging technologies aiming to improve tolerability.

Market differentiation hinges on clinical efficacy, safety profile, patient experience, and clinician familiarity.

Market Challenges

Despite favorable positioning, OSMOPREP faces challenges:

• Generic Competition: The expiration of patents can lead to generic proliferation, exerting downward pressure on prices and margins.
• Brand Loyalty and Clinical Habits: Established prescribing patterns may delay market penetration.
• Safety Concerns: Rare adverse events, such as electrolyte imbalances, could impact substitution rates.

Financial Trajectory

1. Revenue Trends and Forecasts

OSMOPREP’s revenue trajectory remains closely tied to the volume of colorectal screenings, which have seen fluctuations during the COVID-19 pandemic. Post-pandemic, a rebound in elective procedures is anticipated to restore growth. Market research indicates a compound annual growth rate (CAGR) of approximately 5-7% over the next five years, driven by increased screening awareness and technological innovation.

2. Pricing Strategies

The drug’s premium positioning—highlighting patient tolerability—permits higher pricing compared to traditional options. However, price sensitivity, especially in cost-conscious healthcare systems, necessitates strategic balance to sustain competitive margins. Partnering with payers to secure favorable reimbursement terms will support revenue growth.

3. Market Expansion Opportunities

Geographically, emerging markets present untapped potential, particularly where colonoscopy rates are rising due to increasing awareness and healthcare infrastructure development. Regulatory approval timelines and market entry costs vary, but successful penetration could accelerate revenues.

4. Research and Development Impact

Ongoing R&D efforts aim to improve formulations, reduce side effects, and develop combination products. Investment in biosimilar and novel delivery systems could diversify revenue streams. Positive trial outcomes typically catalyze sales surges and boost investor confidence.

5. Intellectual Property and Patent Strategies

The patent landscape for bowel prep formulations influences the drug's exclusivity period. Defensive patent filing and strategic licensing agreements can extend market protection, delaying generic competition and maintaining higher profit margins.

Outlook and Strategic Implications

The outlook for OSMOPREP hinges on market share expansion, pipeline advancement, and regulatory environment stability. Key strategies include:

• Enhanced clinician education emphasizing patient tolerability advantages.
• Broadening access through partnerships with healthcare providers and insurance companies.
• Exploring alternative administration routes or combination therapies.
• Navigating patent expirations with innovation-driven pipeline development.

With the adoption of minimally invasive diagnostic procedures on the rise, OSMOPREP is well-positioned to capitalize on increased procedural volumes. Nevertheless, competitive pressures and price erosion remain critical factors influencing long-term financial performance.

Key Takeaways

• Market growth is driven by increasing colorectal cancer incidence, screening adherence, and patient preferences for low-volume bowel prep options.
• Regulatory approvals and reimbursement policies significantly influence geographical market expansion and revenue streams.
• Competitive differentiation lies in formulation tolerability, safety profile, and clinician familiarity, with ongoing R&D key to sustaining advantages.
• Revenue projections indicate modest but steady growth, contingent on procedural volume recovery post-pandemic and strategic market expansion.
• Patent management and pipeline innovation are crucial to safeguarding profitability amidst generic competition and market saturation.

FAQs

1. What distinguishes OSMOPREP from other bowel preparation agents?
   OSMOPREP's primary advantage is its low-volume, patient-friendly formulation, offering similar efficacy to traditional high-volume solutions with improved tolerability and convenience.

2. How does patent expirations affect OSMOPREP’s market outlook?
   Patent expirations typically lead to increased generic market entries, exerting downward pressure on pricing and margins. Strategic R&D efforts and patent filings are essential to prolong market exclusivity.

3. What role does COVID-19 play in the future market performance of OSMOPREP?
   COVID-19 initially suppressed elective procedures like colonoscopies, but a post-pandemic rebound in screening will likely support increased demand for bowel prep agents, including OSMOPREP.

4. Are there emerging competitors or technologies that could threaten OSMOPREP’s market share?
   Yes, innovations in bowel preparation—such as new formulations with better tolerability or alternative administration methods—could disrupt current market share dynamics.

5. What strategic steps should Otsuka Pharmaceutical pursue to maximize OSMOPREP’s growth?
   Focus should include expanding into emerging markets, strengthening reimbursement negotiations, investing in pipeline innovation, and conducting clinician and patient education campaigns emphasizing the drug’s tolerability benefits.

Conclusion

OSMOPREP stands at the intersection of technological innovation and evolving clinical needs within the bowel preparation market. Its financial trajectory will increasingly depend on strategic positioning—balancing regulatory, competitive, and patient preference factors—to sustain growth amid patent cycles and market maturation. A proactive approach targeting geographical expansion, pipeline enhancement, and stakeholder engagement will be essential to realize its full market potential.

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Sources

1. [1] Otsuka Pharmaceutical. OSMOPREP Official Product Information.
2. [2] World Health Organization. Globocan: Colorectal Cancer Factsheet.
3. [3] MarketResearch.com. Global Bowel Preparation Market Analysis and Forecast.
4. [4] U.S. Food and Drug Administration. OSMOPREP Approval Documentation.
5. [5] IMS Health. Healthcare Trends Post-Pandemic.