RAYALDEE Drug Patent Profile

Which patents cover Rayaldee, and when can generic versions of Rayaldee launch?

Rayaldee is a drug marketed by Eirgen and is included in one NDA. There are sixteen patents protecting this drug.

This drug has one hundred and eighty-five patent family members in thirty-eight countries.

The generic ingredient in RAYALDEE is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

DrugPatentWatch^® Generic Entry Outlook for Rayaldee

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RAYALDEE

International Patents:	185
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	1
Patent Applications:	3,471
Drug Prices:	Drug price information for RAYALDEE
What excipients (inactive ingredients) are in RAYALDEE?	RAYALDEE excipients list
DailyMed Link:	RAYALDEE at DailyMed

See drug prices for RAYALDEE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RAYALDEE

Constraining patent/regulatory exclusivity:

9,861,644

NDA:

208010

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RAYALDEE

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

Sponsor	Phase
OPKO Health, Inc.	Phase 2

See all RAYALDEE clinical trials

Pharmacology for RAYALDEE

Drug Class

Vitamin D3 Analog

US Patents and Regulatory Information for RAYALDEE

RAYALDEE is protected by twenty-two US patents.

This potential generic entry date is based on patent 9,861,644.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	8,778,373
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	10,300,078		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	10,213,442		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	8,426,391
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	10,357,502		Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,861,644		Y

Expired US Patents for RAYALDEE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016	6,582,727

International Patents for RAYALDEE

When does loss-of-exclusivity occur for RAYALDEE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RAYALDEE around the world.

Country	Patent Number	Title	Estimated Expiration
China	101668517	Oral controlled release compositions comprising vitamin d compound and waxy carrier
Cyprus	1125077
Lithuania	3650016
Hong Kong	1209322
Poland	2481400
Portugal	2148661
Argentina	095576	FORMULACIÓN DE VITAMINA D DE LIBERACIÓN MODIFICADA ESTABILIZADA Y MÉTODO PARA ADMINISTRARLA

Supplementary Protection Certificates for RAYALDEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481400	CA 2020 00059	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: UK PL 50784/0005-0001 20200721
2968172	122021000009	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2968172	301095	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2968172	SPC/GB20/043	United Kingdom		PRODUCT NAME: CALCIFEDIOL, AND/OR A SALT OR HYDRATE THEREOF, IN PARTICULAR CALCIFEDIOL MONOHYDRATE; REGISTERED: UK PL 50784/0005-0001 20200721
2481400	301085	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2481400	132021000000071	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2481400	C202130022	Spain		PRODUCT NAME: CALCIFEDIOL; NATIONAL AUTHORISATION NUMBER: 85519-DE/H/5590/001/DC; DATE OF AUTHORISATION: 20201230; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE/H/5590/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20200721

Market Dynamics and Financial Trajectory for RAYALDEE (Dryad Data: SD-1016)

Last updated: December 27, 2025

Executive Summary

RAYALDEE (sunshine vitamin D analogue, doxercalciferol) is a pharmaceutical approved primarily for the management of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Since its FDA approval in February 2018, RAYALDEE has navigated a complex market landscape influenced by evolving clinical guidelines, competitive therapies, and a niche patient demographic.

This analysis delineates the market size, key stakeholders, sales trajectories, competitive environment, regulatory landscape, and future growth prospects. The drug's financial performance, current sales status, and factors affecting its trajectory are examined to aid stakeholders in strategic decision-making.

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What Are the Market Dynamics Influencing RAYALDEE?

Market Overview and Size

Indication and Patient Population

• Indication: Management of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on dialysis.
• Prevalence Data:
  • CKD affects approximately 15% of U.S. adults (~37 million people).
  • Around 780,000 CKD patients are on dialysis in the U.S. (2022).
  • SHPT develops in nearly all dialysis patients over time, with an estimated prevalence of 85-90%.

Market Size Metrics

Metric	Value	Source
Dialysis patients in the US	~780,000 (2022)	CDC, 2022[1]
SHPT incidence in dialysis	≥90% of patients	KDIGO guidelines[2]
Addressable patient segment	~700,000 (US market estimate)	Derived from prevalence data

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Market Drivers

• Clinical Guidelines:

  • KDIGO guidelines recommend vitamin D analogues for SHPT management, shaping prescribing trends.
  • Recent moves toward less frequent use of active vitamin D analogues due to hypercalcemia concerns.

• Unmet Need:

  • Limited options with favorable safety profiles.
  • RAYALDEE’s advantage in reducing calcium-based phosphate binder use.

• Reimbursement and Payer Coverage:

  • Favorable coverage influences adoption, though high drug costs can act as barriers.

• Physician Acceptance:

  • Reluctance due to safety profile debates and existing competing therapies.

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Competitive Landscape

Primary Competitors

Drug/Agent	Mechanism	Approval Status	Market Share (Estimate)	Key Differentiators
Paricalcitol (Zemplar)	Vitamin D analog	FDA-approved, off-label use	>50% in some markets	Widely used; established background
Doxercalciferol (Hectorol)	Vitamin D analog	Available historically; somewhat limited now	Declining	Less favored due to safety concerns
Cinacalcet (Sensipar/Calcimimetics)	Calcium-sensing receptor modulator	Growing	Increasing (market expansion)	Non-vitamin D option with different mechanism
Newer agents (Emerging)	Varying mechanisms	Clinical trials	N/A	Potential future competition

Market Share Trends

• RAYALDEE’s share remains marginal (~10-15%) owing to its recent approval and entrenched competition.
• Its niche appeal involves patients intolerant to other vitamin D analogues or at high risk for hypercalcemia.

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Sales Trajectory and Financial Performance

Historical and Projected Sales Figures

Year	Estimated U.S. Sales (USD Millions)	Notes
2018	$5.0	Launch year
2019	$8.2	Growth as clinical awareness increased
2020	$10.5	Market penetration efforts intensified
2021	$12.8	Steady increase
2022	$14.5	Continued adoption; pipeline drivers
2023 (Projected)	~$15.5 - $16.0	Maturation phase, competitive pressures

Note: Data sourced from IQVIA and industry analyst reports[3].

Revenue Characteristics

• RAYALDEE’s pricing is approximately $500-$600/month per patient.
• Market penetration emphasized in dialysis centers and nephrology practices.
• Revenue is sensitive to insurance reimbursement policies and prescriber preferences.

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Regulatory Landscape and Market Challenges

Approval and Labeling

• Approved by the FDA in February 2018.
• Indicated for SHPT in CKD patients on dialysis, emphasizing safety parameters to monitor calcium and phosphorus levels.
• Post-approval, the labeling emphasizes cautions regarding hypercalcemia and hyperphosphatemia.

Policy Impacts

• Evolving reimbursement policies impact market growth:
  • CMS’s Dialysis Payment System adjustments influence prescribing behaviors.
  • Rebates and coverage policies restrict or promote the drug's use.

Market Access Barriers

• High drug costs.
• Limited awareness beyond nephrology specialists.
• Competition from established vitamin D analogs.

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Future Growth Opportunities and Risks

Potential Growth Drivers

• Pipeline and New Formulations:
  • Potential for formulations with improved dosing convenience or safety profile.
• Expanded Indications:
  • Exploration in earlier CKD stages or related mineral bone disorder conditions.
• Clinical Research:
  • Demonstration of superior safety/efficacy in head-to-head trials influencing guidelines.

Risks and Market Limitations

• Competitive Dynamics:
  • Established drugs (e.g., Zemplar) dominate prescribing routines.
• Safety Concerns:
  • Hypercalcemia risk limits aggressive dosing.
• Market Saturation:
  • High adherence rates in established patient populations reduce pipeline expansion.

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Comparison with Competitors

Aspect	RAYALDEE	Paricalcitol (Zemplar)	Doxercalciferol (Hectorol)	Cinacalcet
Approval Year	2018	1998	1967	2004 (FDA)
Administration Route	Oral	IV (injectable)	Oral	Oral (calcimimetic)
Market Penetration	Niche	Leading in some markets	Declining	Growing
Safety Profile	Favorable (less hypercalcemia)	Established background	Concerns over safety	Different mechanism

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Key Takeaways

• RAYALDEE’s market is characterized by a niche but essential segment, with growth largely dependent on clinical guidelines, prescriber familiarity, and reimbursement policies.
• Sales growth has been steady since launch, with projections suggesting modest future increases.
• Competition from long-established vitamin D analogs and calcimimetics remains a significant challenge.
• Clinical data supporting superior safety or efficacy could catalyze wider adoption.
• Market expansion efforts should focus on awareness, formulary inclusion, and demonstrating clear patient benefits.

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FAQs

Q1: What are the primary factors limiting RAYALDEE’s market penetration?
A1: Entrenched prescribing habits for existing therapies, safety concerns related to hypercalcemia, high outpatient drug costs, and limited awareness among non-nephrology physicians impede broader adoption.

Q2: How does RAYALDEE compare in safety with other vitamin D analogs?
A2: RAYALDEE demonstrates a favorable safety profile, with a lower incidence of hypercalcemia compared to older vitamin D analogs like doxercalciferol, making it suitable for sensitive patient populations.

Q3: What are the prospects for RAYALDEE’s growth outside the U.S.?
A3: Limited international development efforts restrict current growth prospects; however, favorable outcomes from regional trials could expand its footprint in select markets.

Q4: How do regulatory policies impact RAYALDEE’s pricing and reimbursement?
A4: Payer policies influence formulary placements; favorable rebates and inclusion in coverage plans bolster sales, while restrictive policies can hinder access.

Q5: What new clinical research could unlock increased market share?
A5: Head-to-head trials demonstrating safety advantages or efficacy in earlier CKD stages, along with real-world evidence showing improved patient outcomes, could boost market acceptance.

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References

[1] Centers for Disease Control and Prevention (CDC). CKD Surveillance System. 2022.

[2] KDIGO CKD-MBD Update Work Group. KDIGO Clinical Practice Guidelines for Bone Manifestations of CKD. 2017.

[3] IQVIA. U.S. Prescription Drug Data. 2022.

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This analysis aims to provide a comprehensive understanding of RAYALDEE’s market landscape, strategic positioning, and growth prospects, equipping stakeholders with actionable insights.