PHOSLO Drug Patent Profile

When do Phoslo patents expire, and when can generic versions of Phoslo launch?

Phoslo is a drug marketed by Fresenius Medcl and is included in two NDAs.

The generic ingredient in PHOSLO 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

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

Summary for PHOSLO

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	7
Drug Prices:	Drug price information for PHOSLO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHOSLO
What excipients (inactive ingredients) are in PHOSLO?	PHOSLO excipients list
DailyMed Link:	PHOSLO at DailyMed

See drug prices for PHOSLO

See drug sales revenues for PHOSLO

Recent Clinical Trials for PHOSLO

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

Sponsor	Phase
Amgen	N/A
Azienda Ospedaliera Sant'Anna	N/A
Albany Medical College	Phase 4

See all PHOSLO clinical trials

US Patents and Regulatory Information for PHOSLO

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	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001		DISCN	No	No
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001		DISCN	Yes	No
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001		DISCN	No	No
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990		DISCN	Yes	No

Expired US Patents for PHOSLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	4,870,105
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	4,870,105
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	6,576,665
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	4,870,105

International Patents for PHOSLO

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

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

Supplementary Protection Certificates for PHOSLO

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

PHOSLO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phoslo

Introduction

Phoslo, a calcium acetate phosphate binder, is a crucial medication for managing phosphate levels in patients with end-stage renal disease (ESRD). Here, we delve into the market dynamics and financial trajectory of Phoslo, highlighting its significance, market trends, and financial performance.

Market Significance

Phoslo is used to control phosphate levels in the blood, a critical aspect of managing ESRD. Excess phosphate can lead to severe health issues, including bone disease, thyroid problems, and vascular calcification. The demand for phosphate binders like Phoslo is driven by the growing prevalence of chronic kidney disease and the need for effective dialysis management[4].

Market Size and Growth

The global phosphate binder market, which includes Phoslo, is substantial. As of 2006, this market exceeded $500 million worldwide. The acquisition of PhosLo by Fresenius Medical Care from Nabi Biopharmaceuticals for $65 million, along with royalties and milestone payments, underscores the market's potential and the strategic importance of phosphate binders in the renal care segment[4].

Key Players and Acquisitions

Fresenius Medical Care's acquisition of the PhosLo business from Nabi Biopharmaceuticals was a significant move in the market. This acquisition allowed Fresenius to expand its clinical therapy offerings and enhance its growth opportunities in the renal care sector. The deal included a cash payment of $65 million, royalties on new product formulations, and milestone payments totaling $20 million over several years[4].

Financial Performance

The financial performance of PhosLo is closely tied to the overall phosphate binder market and the strategic initiatives of its parent company, Fresenius Medical Care. Here are some key financial highlights:

• Revenue: At the time of the acquisition, PhosLo generated approximately $40 million in revenues in the U.S. alone. This figure indicates a strong market presence and revenue potential[4].
• Acquisition Cost: The total consideration for the acquisition was $65 million, plus additional royalties and milestone payments. This investment reflects the market value and growth potential of PhosLo[4].
• Growth Opportunities: The integration of PhosLo into Fresenius Medical Care's portfolio has enhanced the company's growth opportunities in the renal care market. This includes expanding clinical therapy offerings and improving bone mineralization management during dialysis treatment[4].

Market Trends

Several trends influence the market dynamics of PhosLo:

• Increasing Prevalence of ESRD: The growing number of patients with end-stage renal disease drives the demand for phosphate binders like PhosLo.
• Advancements in Dialysis Management: Improvements in dialysis technologies and therapies, including the use of phosphate binders, are crucial for managing ESRD effectively.
• Regulatory and Reimbursement Environment: Medicare coverage and other reimbursement policies play a significant role in the financial trajectory of PhosLo. Medicare prescription drug plans and savings programs like those offered by GoodRx can impact patient access and affordability[5].

Competitive Landscape

The phosphate binder market is competitive, with several products available to manage phosphate levels in ESRD patients. PhosLo competes with other calcium-based and non-calcium-based phosphate binders. The competitive landscape is influenced by factors such as efficacy, safety, patient compliance, and cost.

Future Outlook

The future outlook for PhosLo is positive, driven by the increasing need for effective phosphate management in ESRD patients. Here are some key points:

• Growing Demand: The rising prevalence of chronic kidney disease and the need for advanced dialysis management will continue to drive demand for phosphate binders.
• Innovations and Improvements: Continuous innovations in phosphate binder formulations and delivery methods can enhance the market position of PhosLo.
• Strategic Initiatives: Fresenius Medical Care's integrated "pharma-tech" therapy approach, which includes PhosLo, is expected to enhance patient outcomes and drive market growth[4].

Key Takeaways

• Market Significance: Phoslo is a critical medication for managing phosphate levels in ESRD patients.
• Financial Performance: The acquisition by Fresenius Medical Care and the revenue generated by PhosLo indicate its financial viability.
• Market Trends: Increasing ESRD prevalence, advancements in dialysis management, and regulatory environments shape the market dynamics.
• Future Outlook: Growing demand and strategic initiatives by Fresenius Medical Care are expected to drive the market forward.

FAQs

1. What is Phoslo used for? Phoslo is used to control phosphate levels in the blood of patients with end-stage renal disease (ESRD).

2. Who acquired the PhosLo business? Fresenius Medical Care acquired the PhosLo business from Nabi Biopharmaceuticals.

3. What was the acquisition cost of PhosLo? The acquisition cost was $65 million, plus royalties and milestone payments.

4. How does Medicare coverage affect PhosLo? Medicare prescription drug plans and savings programs can impact patient access and affordability of PhosLo.

5. What are the future growth prospects for PhosLo? The future outlook is positive, driven by the increasing need for effective phosphate management in ESRD patients and strategic initiatives by Fresenius Medical Care.

Sources

1. Fresenius Medical Care to acquire phosphate binder business from Nabi Pharmaceuticals - Fresenius Medical Care.
2. Phoslo Medicare Coverage and Co-Pay Details - GoodRx.
3. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance - Pfizer (though not directly related, provides context on pharmaceutical market trends).
4. Corporate Overview 2011 Investor Day - Perrigo (provides broader context on pharmaceutical market strategies).