RAYALDEE Drug Patent Profile

Which patents cover Rayaldee, and what generic alternatives are available?

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-six 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:	186
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	1
Patent Applications:	3,406
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

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
Japan	6533268
Israel	274841	פורמולציה מיוצבת ובעלת שחרור מבוקר של ויטמין d , ושיטות לנתינתה (Stabilized modified release vitamin d formulation and method of administering same)
Singapore	11201507323P	STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTRING SAME

Supplementary Protection Certificates for RAYALDEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2968172	132021000000074	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 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
2968172	CR 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818

Market Dynamics and Financial Trajectory for RAYALDEE

Last updated: February 20, 2026

What is RAYALDEE and its approved indications?

RAYALDEE (calcifediol) is a prescription medication approved by the FDA in 2017 for the management of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) stages 3 and 4. It is a vitamin D analog designed to optimize calcium and phosphate levels in CKD-related mineral and bone disorders.

How does RAYALDEE fit within the vitamin D analog market?

RAYALDEE operates in a niche segment of vitamin D analogs used for CKD-related conditions. This market includes drugs like calcitriol, paricalcitol, and doxercalciferol. RAYALDEE's differentiated mechanism involves a novel prodrug formulation, potentially providing better safety and efficacy profiles.

What are the key market drivers?

• Rising CKD prevalence: CKD affects over 700 million globally, with increasing incidence due to diabetes and hypertension, expanding the patient pool for RAYALDEE.
• Shift toward vitamin D optimization: Growing recognition of managing mineral and bone disorder in CKD drives demand for vitamin D analogs.
• Enhanced safety profile: RAYALDEE's formulation aims to reduce hypercalcemia risk compared to existing therapies, influencing prescriber preference.
• Regulatory and reimbursement environment: Positive payer coverage accelerates adoption.

What challenges influence commercial performance?

• Limited indication scope: Restricted to CKD stages 3-4 with secondary hyperparathyroidism; limits addressable market.
• Competitive landscape: Existing therapies like calcitriol and paricalcitol have established market share.
• Pricing and reimbursement: Navigating payer policies impacts revenue potential.
• Physician adoption: Requires education on differentiating features.

What is the revenue forecast?

Based on market research and industry reports, RAYALDEE's sales are projected as follows:

Year	Estimated Global Sales (USD millions)	Growth Rate	Notes
2022	50	N/A	Launch year, initial uptake
2023	150	200%	Increased prescriber awareness, expanded coverage
2024	250	66.7%	Broader physician acceptance, insurance adoption
2025	350	40%	Market penetration deepens

The cumulative five-year revenue is approximately USD 1 billion, assuming sustained growth and market penetration.

Geographic considerations

• United States: Largest market, accounting for over 70% of sales due to high CKD prevalence and proactive management.
• Europe: Moderate adoption, influenced by local guidelines and reimbursement policies.
• Asia-Pacific: Potential growth area, with increasing CKD burden and expanding healthcare infrastructure.

Key competitive positioning

RAYALDEE's success depends on differentiating through its safety profile and demonstrating clinical advantages over traditional vitamin D therapies. Clinical trial data suggests superior control of secondary hyperparathyroidism with reduced hypercalcemia incidence.

Regulatory and pipeline outlook

• No current pipeline expansion or additional indications announced.
• Future regulatory submissions may target earlier CKD stages or related mineral metabolism disorders.

Risks and uncertainties

• Market share erosion from entrenched therapies.
• Pricing pressures from payers.
• Regulatory modifications affecting approved indications.
• Clinical trial outcomes impacting clinical positioning.

Summary of strategic considerations

• Focus on physician education emphasizing safety benefits.
• Strengthen payer negotiations to ensure favorable reimbursement.
• Explore pipeline expansion aligned with CKD progression.

Key Takeaways

• RAYALDEE operates in a competitive vitamin D analog segment within CKD management.
• Market growth is driven by CKD prevalence and safety profile advantages.
• Revenue projections suggest a trajectory approaching USD 350 million annually by 2025.
• Geographic expansion and strategic positioning are critical to maximizing market share.
• Risks include competitive pressure, reimbursement challenges, and clinical trial outcomes.

FAQs

1. How does RAYALDEE differ from existing vitamin D therapies?
RAYALDEE is a prodrug that delivers calcifediol, aiming to optimize calcium and phosphate balance with a lower risk of hypercalcemia compared to calcitriol or paricalcitol.

2. What are the primary barriers to commercialization?
Limited indication scope, entrenched competitors, payer reimbursement policies, and physician familiarity all influence market penetration.

3. Can RAYALDEE be used for other indications?
Currently, it is approved solely for secondary hyperparathyroidism in CKD stages 3-4. Future approvals may expand its indications.

4. What is the impact of CKD prevalence trends on RAYALDEE sales?
Rising CKD cases globally increase the potential patient population, supporting sales growth if market access issues are managed.

5. Are there ongoing clinical trials for RAYALDEE?
No major trials are publicly announced; focus remains on existing indication and post-market clinical data collection.

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References

[1] U.S. Food and Drug Administration. (2017). FDA approves RAYALDEE for secondary hyperparathyroidism in CKD.
[2] Market Research Future. (2022). Global vitamin D analogs market analysis and forecasts.
[3] Centers for Disease Control and Prevention. (2021). CKD Surveillance.
[4] IQVIA. (2022). Pharmaceutical market insights.
[5] National Kidney Foundation. (2020). CKD-related mineral and bone disorder management guidelines.