PHOSLYRA Drug Patent Profile

When do Phoslyra patents expire, and what generic alternatives are available?

Phoslyra is a drug marketed by Fresenius Medcl and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in sixteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phoslyra

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

Summary for PHOSLYRA

International Patents:	23
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
Drug Prices:	Drug price information for PHOSLYRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHOSLYRA
What excipients (inactive ingredients) are in PHOSLYRA?	PHOSLYRA excipients list
DailyMed Link:	PHOSLYRA at DailyMed

See drug prices for PHOSLYRA

See drug sales revenues for PHOSLYRA

Recent Clinical Trials for PHOSLYRA

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

Sponsor	Phase
Vifor Fresenius Medical Care Renal Pharma	Phase 3
Fresenius Medical Care North America	Phase 4

See all PHOSLYRA clinical trials

Paragraph IV (Patent) Challenges for PHOSLYRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHOSLYRA	Oral Solution	calcium acetate	667 mg/5 mL	022581	2	2013-12-05

US Patents and Regulatory Information for PHOSLYRA

PHOSLYRA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No			Y

International Patents for PHOSLYRA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1202815	醋酸鈣的液體組合物 (LIQUID COMPOSITIONS OF CALCIUM ACETATE)
New Zealand	574331	LIQUID COMPOSITIONS OF CALCIUM ACETATE
Russian Federation	2009104774	ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ
South Africa	200900472	Liquid compositions of calcium acetate
Spain	2382993
World Intellectual Property Organization (WIPO)	2008011126

Supplementary Protection Certificates for PHOSLYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2365988	122018000012	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
2957286	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
0521471	C300125	Netherlands		PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712

Market Dynamics and Financial Trajectory for PHOSLYRA

Introduction to PHOSLYRA

PHOSLYRA, a brand name for calcium acetate, is a medication approved by the FDA for the treatment of hyperphosphatemia, a condition characterized by elevated levels of phosphate in the blood, often seen in patients with chronic kidney disease (CKD) and those undergoing dialysis.

Market Context: Hyperphosphatemia Treatment

The hyperphosphatemia treatment market is experiencing significant growth, driven by the increasing prevalence of CKD and the need for effective phosphate binders. The market is projected to grow from $1.31 billion in 2023 to $2.28 billion by 2030, at a CAGR of 8.2%[1].

Impact of COVID-19

The COVID-19 pandemic had a temporary slowing effect on the hyperphosphatemia treatment market due to supply chain disruptions and reduced patient visits for dialysis. However, the market saw a resurgence in 2020, partly due to increased sales of products like Auryxia and Velphoro, which helped mitigate the decline[1].

Market Segmentation and Distribution Channels

The hyperphosphatemia treatment market is segmented by distribution channels into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies dominate the market, driven by the high number of patients seeking dialysis treatment in hospital facilities. Online pharmacies are expected to record the fastest CAGR during the forecast period due to the increasing shift towards e-commerce platforms[1].

Regional Market Dynamics

North America, particularly the U.S., holds a significant share of the hyperphosphatemia treatment market due to the large number of CKD patients undergoing dialysis. Europe and Asia Pacific are also key regions, with Europe seeing increased demand for iron-based and sevelamer-based phosphate binders, and Asia Pacific experiencing a rise in the prescription of calcium-based phosphate binders[1].

Competitive Landscape

The market for hyperphosphatemia treatments is competitive, with major players such as Sanofi, Akebia Therapeutics, Inc., and CSL. These companies are focusing on R&D to develop new therapeutics and protect their products from generic competition. PHOSLYRA, as a calcium acetate product, competes in this landscape by offering an effective solution for managing hyperphosphatemia[1].

Financial Performance of Key Players

Companies involved in the hyperphosphatemia treatment market are experiencing steady financial growth. For instance, Akebia Therapeutics, Inc. saw a 16% increase in revenue from Auryxia in 2020, contributing to the overall market growth. However, the financial performance can be volatile due to factors like generic competition and regulatory approvals[1].

Generic Availability and Market Impact

PHOSLYRA, being a brand name for calcium acetate, faces competition from generic versions. The availability of generic calcium acetate can impact the market share of PHOSLYRA, as generics often offer a more affordable alternative. However, brand loyalty and the reputation of the manufacturer can help maintain market presence[4].

Regulatory and Approval Processes

The approval process for new drugs, including those for hyperphosphatemia, is stringent. Companies like Ardelyx, which is developing tenapanor (XPHOZAH) for the control of serum phosphorus in CKD patients, face challenges such as Complete Response Letters (CRLs) from the FDA. These regulatory hurdles can significantly impact the financial trajectory and market entry of new products[3].

Financial Trajectory for PHOSLYRA

While specific financial data for PHOSLYRA is not readily available, the overall market trends suggest that calcium acetate products like PHOSLYRA benefit from the growing demand for hyperphosphatemia treatments. The revenue growth in this segment is expected to be robust, driven by the increasing patient population and the need for effective phosphate binders.

Revenue Projections

Given the market growth rate, products like PHOSLYRA are likely to see increased revenue. However, the exact financial trajectory would depend on factors such as market share, competition from generics, and the company's ability to maintain or increase its customer base.

Challenges and Opportunities

The financial trajectory of PHOSLYRA will be influenced by the company's ability to navigate regulatory approvals, manage competition, and capitalize on the growing demand for hyperphosphatemia treatments. Emerging markets and the shift towards online pharmacies also present opportunities for growth.

Key Takeaways

• The hyperphosphatemia treatment market is growing at a CAGR of 8.2% from 2023 to 2030.
• PHOSLYRA competes in a market dominated by hospital pharmacies but with a growing online segment.
• Regulatory approvals and generic competition are key factors influencing the financial trajectory of PHOSLYRA.
• The increasing prevalence of CKD and the need for effective phosphate binders drive market growth.

FAQs

1. What is PHOSLYRA used for?

PHOSLYRA is used for the treatment of hyperphosphatemia, a condition characterized by elevated levels of phosphate in the blood, often seen in patients with chronic kidney disease (CKD) and those undergoing dialysis.

2. How is the hyperphosphatemia treatment market expected to grow?

The hyperphosphatemia treatment market is projected to grow from $1.31 billion in 2023 to $2.28 billion by 2030, at a CAGR of 8.2%.

3. What impact did COVID-19 have on the hyperphosphatemia treatment market?

COVID-19 caused a temporary slowdown in the market due to supply chain disruptions and reduced patient visits for dialysis, but the market saw a resurgence in 2020 driven by increased sales of certain products.

4. Which distribution channel dominates the hyperphosphatemia treatment market?

Hospital pharmacies dominate the market, driven by the high number of patients seeking dialysis treatment in hospital facilities.

5. What are the key challenges for PHOSLYRA in the market?

Key challenges include regulatory approvals, competition from generics, and managing market share in a competitive landscape.

Cited Sources:

1. Fortune Business Insights: Hyperphosphatemia Treatment Market Size | Analysis [2030]
2. PhosAgro: Financial Performance – Strategic report
3. Ardelyx INC: Form 10-Q filed 11/03/2022
4. Drugs.com: Generic Phoslyra Availability - Drugs.com