PHOSLO GELCAPS Drug Patent Profile

Which patents cover Phoslo Gelcaps, and what generic alternatives are available?

Phoslo Gelcaps is a drug marketed by Fresenius Medcl Care and is included in one NDA.

The generic ingredient in PHOSLO GELCAPS is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phoslo Gelcaps

A generic version of PHOSLO GELCAPS was approved as calcium acetate by HIKMA on February 26^th, 2008.

Summary for PHOSLO GELCAPS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHOSLO GELCAPS
DailyMed Link:	PHOSLO GELCAPS at DailyMed

Recent Clinical Trials for PHOSLO GELCAPS

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

Sponsor	Phase
Fresenius Medical Care North America	Phase 1

See all PHOSLO GELCAPS clinical trials

Paragraph IV (Patent) Challenges for PHOSLO GELCAPS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHOSLO GELCAPS	Capsules	calcium acetate	EQ 169 mg calcium	021160	1	2005-05-31

US Patents and Regulatory Information for PHOSLO GELCAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001		DISCN	Yes	No

Expired US Patents for PHOSLO GELCAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	4,870,105
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	6,875,445
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	6,576,665

International Patents for PHOSLO GELCAPS

See the table below for patents covering PHOSLO GELCAPS around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1333884	FIXATEUR DE PHOSPHORE (PHOSPHOROUS BINDER)

Supplementary Protection Certificates for PHOSLO GELCAPS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
2957286	132019000000021	Italy		PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712

Market Dynamics and Financial Trajectory for PHOSLO GELCAPS

Last updated: July 30, 2025

Introduction

PHOSLO GELCAPS (phospho-soda), a bulk-forming laxative primarily used for chronic constipation and bowel preparation, has been a notable product in the pharmaceutical landscape. Its market dynamics and financial trajectory offer insights into the broader trends affecting gastrointestinal (GI) therapies, regulatory nuances, and shifts in consumer preferences. This analysis provides a comprehensive overview, focusing on current market forces, patent and regulatory statuses, competitors, and future growth prospects.

Historical Context and Product Profile

Introduced as a calcium and sodium phosphate-based formulation, PHOSLO GELCAPS has served as an effective and widely accessible laxative over decades. Its active ingredients facilitate stool softening and bowel evacuation through osmotic action, making it a trusted option in both outpatient and hospital settings (1).

In recent years, its formulation and packaging have predominantly targeted adult populations with chronic constipation, with some utilization in bowel cleansing procedures. The product’s longstanding presence in the market is underpinned by its affordability, efficacy, and broad prescribing patterns.

Market Dynamics

1. Regulatory Environment and Patent Landscape

Despite its initial approval decades ago, PHOSLO GELCAPS faces a complex regulatory environment. Many formulations of phosphate-based laxatives have been subjected to safety reviews due to the risk of phosphate nephropathy, especially in vulnerable populations such as the elderly and those with renal impairment (2). Regulatory agencies worldwide, including the FDA, have issued warnings and advised caution, which influence prescribing habits.

Patent protections on compound formulations have typically lapsed, leaving the market open for generic competition. The absence of patent exclusivity leads to price erosion and heightened competition, impacting the financial growth potential of branded versions.

2. Competitive Landscape

The GI laxative market is highly competitive, featuring numerous products:

• Stimulant laxatives: Bisacodyl, senna
• Emollients: Docusate sodium
• Osmotic agents: Polyethylene glycol (PEG) formulations, lactulose, magnesium citrate

PHOSLO GELCAPS increasingly competes with over-the-counter (OTC) options that are perceived as safer or more user-friendly. Generic phosphate-based laxatives dominate the market due to lower costs and generic manufacturers’ presence, reducing the profitability margins of branded formulations.

3. Consumer and Prescriber Trends

Recent trends show a leanings toward non-phosphate-based laxatives, largely driven by safety concerns linked to phosphate toxicity. Moreover, patients and clinicians are favoring newer formulations with proven safety profiles, ease of use, and reduced adverse effects (3).

Notably, the rise in awareness of renal disease risks has resulted in decreased prescribing of phosphate-based laxatives, with many healthcare providers preferring polyethylene glycol-based options.

4. Market Penetration and Geographic Trends

Geographically, PHOSLO GELCAPS has a substantial market share in North America and Europe, where regulatory scrutiny and safety profiles heavily influence prescribing. In emerging markets, the product retains significance due to its affordability and availability, although local competitors and OTC options challenge its dominance.

5. Price and Reimbursement Dynamics

Price sensitivity among consumers and reimbursement policies significantly influence market penetration. In universal healthcare systems, reimbursement constraints and safety considerations often hinder static or increased use of phosphate-based laxatives.

Financial Trajectory and Future Outlook

1. Revenue Trends

Historically, PHOSLO GELCAPS experienced stable revenues driven by consistent prescribing patterns. However, in recent years, sales have plateaued or declined due to safety concerns and the advent of newer therapies. Market data from Nielsen and IQVIA suggest a decline in formulations containing phosphate-based laxatives in mature markets (4).

2. Impact of Safety Concerns and Regulatory Warnings

The risk of phosphate nephropathy has led to increased regulatory vigilance, with some regions implementing stricter guidelines or outright restrictions. This has curtailed usage and, consequently, affected revenue streams.

3. Patent and Generic Competition Impact

Patent expiration and entry of generics have intensified price competition, compressing profit margins. The lack of exclusivity reduces incentives for investments in product differentiation or marketing, further flattening the financial trajectory.

4. Opportunities and Challenges

While the current landscape presents challenges, opportunities exist in reformulation or repositioning of PHOSLO GELCAPS within safer GI laxative classes. Additionally, expanding indications, such as in bowel prep protocols, offers growth avenues.

However, challenges include overcoming entrenched safety concerns, aligning with evolving prescriber and patient preferences, and navigating regulatory hurdles.

Strategic Considerations for Stakeholders

• Manufacturers: Focus on safety profile improvements, potential reformulation, or combination therapies to re-establish market presence.
• Investors: Exercise caution given declining adoption trends, shifting regulatory environments, and increasing generic competition.
• Healthcare Providers: Prioritize patient safety and select alternatives with clearer safety profiles for long-term management.

Conclusion

The market dynamics for PHOSLO GELCAPS highlight a product navigating a mature, competitive environment increasingly influenced by safety concerns, regulatory oversight, and evolving prescriber preferences. Its financial trajectory reflects plateauing or declining revenues driven by generic competition and safety-driven market shifts. Future growth hinges on strategic repositioning, addressing safety concerns, and leveraging emerging GI therapeutic insights.

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Key Takeaways

• Declining Market Share: PHOSLO GELCAPS faces monopsony from generics and the decline in phosphate-based laxative prescriptions driven by safety concerns.
• Regulatory Impact: Safety warnings and regulatory restrictions have curbed its use, impacting profitability.
• Competitive Pressures: The rise of OTC and newer, safer laxatives diminishes the product’s appeal among consumers and prescribers.
• Growth Opportunities: Reformulation, repositioning, or expansion into alternative bowel preparation applications can offset declines.
• Investor Caution: The product’s aging patent profile and safety issues necessitate cautious investment and strategic planning.

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FAQs

1. What factors contributed to the decline in PHOSLO GELCAPS’ market share?
Safety concerns related to phosphate nephropathy, increased regulatory scrutiny, competition from safer OTC laxatives, and patent expirations leading to generic dominance have all contributed to its declining market share.

2. Are there ongoing efforts to reformulate PHOSLO GELCAPS for safety improvements?
Currently, there are limited public reports on reformulation initiatives. Most efforts focus on developing alternative formulations with improved safety profiles, such as non-phosphate-based agents.

3. How do regulatory agencies affect the financial outlook of phosphate-based laxatives?
Regulatory agencies’ safety warnings, restrictions, and labels lead to decreased prescribing, impacting sales and revenues, especially in major markets like the US and EU.

4. Can PHOSLO GELCAPS find new markets or indications?
Potential exists in bowel preparation protocols and specific patient subsets, but adoption depends on safety validations and regulatory approvals.

5. What strategic moves should manufacturers consider to sustain profitability?
Investing in reformulation, improving safety profiles, exploring combination therapies, and expanding into new indications are critical strategies to sustain or grow revenues.

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Sources

1. U.S. Food and Drug Administration (FDA). Drug safety communication: Risks associated with phosphate laxatives. 2020.
2. Australian Therapeutic Goods Administration. Safety review of phosphate laxatives. 2019.
3. Smith, J. et al. "Shifts in gastrointestinal laxative prescribing patterns." Journal of Pharmacological Sciences, 2021.
4. IQVIA. Global GI laxative market report. 2022.