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 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-two 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
Finished Product Suppliers / Packagers:	2
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	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	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001

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
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
2365988	2018C/006	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2957286	1990003-4	Sweden		PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	SPC/GB19/003	United Kingdom		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721

PHOSLO GELCAPS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PhosLo Gelcaps

Introduction

PhosLo Gelcaps, containing calcium acetate, are a crucial medication for controlling hyperphosphatemia in patients with end-stage renal failure. Understanding the market dynamics and financial trajectory of PhosLo Gelcaps is essential for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

The demand for PhosLo Gelcaps is driven by several key factors:

Growing Pharmaceutical Industry

The global pharmaceutical industry is experiencing robust growth, driven by advancements in drug delivery technologies and the increasing prevalence of chronic diseases. This growth directly impacts the demand for pharmaceutical excipients and formulations like PhosLo Gelcaps[1].

Advancements in Drug Delivery Technologies

The integration of cutting-edge technologies in drug delivery systems, such as controlled-release and modified-release formulations, is a significant driver. PhosLo Gelcaps, with their specific formulation, benefit from these advancements[1].

Increasing Healthcare Investments

Expanding pharmaceutical manufacturing capabilities and increasing healthcare investments in emerging economies are also driving the market. These investments enhance the production and distribution of medications like PhosLo Gelcaps[1].

Market Segmentation

The market for PhosLo Gelcaps can be segmented in several ways:

By Application

PhosLo Gelcaps fall under the category of stabilizing agents and desired release agents. They are specifically used for controlling hyperphosphatemia, which is a critical application in the management of end-stage renal failure[1].

By Formulation

PhosLo Gelcaps are classified under oral formulations, specifically gelatin capsules. This formulation is crucial for the controlled release of calcium acetate, ensuring effective management of hyperphosphatemia[1].

By Functionality

As a stabilizing agent, PhosLo Gelcaps ensure the stability and bioavailability of the active pharmaceutical ingredient (API), which is calcium acetate in this case. This functionality is vital for the efficacy of the medication[1].

Financial Performance

The financial performance of PhosLo Gelcaps is significant, given their market position:

Revenue

Historically, PhosLo Gelcaps have generated substantial revenue. For instance, in 2015, PhosLo Gelcaps had annual US sales of $54.5 million[5].

Market Growth

The global pharmaceutical excipients market, which includes products like PhosLo Gelcaps, is expected to grow continuously. The market is driven by the increasing demand for pharmaceutical formulations and advancements in drug delivery technologies, which suggests a positive financial trajectory for PhosLo Gelcaps[1].

Competitive Landscape

The competitive landscape for PhosLo Gelcaps involves several key players:

Major Manufacturers

Companies like Fresenius Medical Care and Physicians Total Care, Inc. are involved in the manufacturing and distribution of PhosLo Gelcaps. Other players in the broader pharmaceutical excipients market include major companies like Catalent Inc., Capsugel (a Lonza Co.), and EuroCaps Ltd.[1][4].

Generic Competition

The launch of generic versions of PhosLo Gelcaps, such as the one by Lupin, can impact the market dynamics. Generic competition can reduce the market share of the original product but also expands access to the medication[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of PhosLo Gelcaps:

FDA Approval and Compliance

PhosLo Gelcaps have undergone rigorous clinical trials and have received FDA approval. Compliance with regulatory standards is essential, and manufacturers must ensure that their products meet these requirements. For example, the FDA reviewed the bioequivalence of liquid PhosLo to PhosLo Gelcaps, ensuring safety and efficacy[3].

Safety and Efficacy

Regulatory bodies emphasize the safety and efficacy of pharmaceutical products. Studies have shown that PhosLo Gelcaps are safe and effective, with minimal adverse events reported. This positive safety profile supports their continued use and market presence[3].

Geographical Market

The geographical market for PhosLo Gelcaps is diverse:

Emerging Economies

Emerging economies are experiencing significant growth in pharmaceutical manufacturing and healthcare investments. This growth is expected to drive the demand for PhosLo Gelcaps in these regions[1].

Developed Markets

In developed markets, the demand for PhosLo Gelcaps is stable, driven by the ongoing need for effective management of hyperphosphatemia in patients with end-stage renal failure[1].

Future Outlook

The future outlook for PhosLo Gelcaps is promising:

Continuous Market Expansion

The pharmaceutical excipients market, including products like PhosLo Gelcaps, is poised for continuous expansion. This growth is driven by the integration of cutting-edge technologies and the increasing demand for specialized drug formulations[1].

Strategic Partnerships and Innovations

Manufacturers are focusing on strategic partnerships, acquisitions, and product development to innovate and introduce new excipient formulations. This strategic focus is expected to maintain the competitive edge of PhosLo Gelcaps in the market[1].

Key Takeaways

• Growing Demand: Driven by the expanding pharmaceutical industry and advancements in drug delivery technologies.
• Regulatory Compliance: Ensuring safety and efficacy through rigorous FDA approval processes.
• Competitive Landscape: Involves major manufacturers and generic competition.
• Geographical Growth: Significant growth in emerging economies and stable demand in developed markets.
• Future Outlook: Continuous market expansion driven by technological innovations and strategic partnerships.

FAQs

1. What is the primary use of PhosLo Gelcaps? PhosLo Gelcaps are primarily used for controlling hyperphosphatemia in patients with end-stage renal failure.

2. Who are the major manufacturers of PhosLo Gelcaps? Major manufacturers include Fresenius Medical Care and Physicians Total Care, Inc.

3. How does the regulatory environment impact PhosLo Gelcaps? The regulatory environment ensures compliance with safety and efficacy standards through FDA approval and ongoing monitoring.

4. What is the financial performance of PhosLo Gelcaps? Historically, PhosLo Gelcaps have generated significant revenue, with annual US sales of $54.5 million in 2015.

5. What is the future outlook for PhosLo Gelcaps? The future outlook is promising, with continuous market expansion driven by technological innovations and strategic partnerships.

Sources

1. ResearchAndMarkets.com - Global Pharmaceutical Excipients Market Analysis, Competitive Landscape and Forecasts 2024-2033.
2. DailyMed - PhosLo Calcium Acetate Capsule.
3. FDA - 022581Orig1s000 SumR.
4. BCC Research - Softgel Capsules: Global Markets.
5. Lupin - Lupin Launches Generic PhosLo® in the US.