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 ninety-two 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:	192
US Patents:	16
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for RAYALDEE

RAYALDEE is protected by twenty-two US patents.

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
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y

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

Germany

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

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
South Korea	101847947
World Intellectual Property Organization (WIPO)	2007092755
South Korea	20190028822
Lithuania	3095447
Serbia	60846	STABILIZOVANA FORMULACIJA VITAMINA D SA MODIFIKOVANIM OSLOBAĐANJEM I POSTUPAK ZA DAVANJE ISTE (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTRING SAME)
Portugal	3332773
Japan	5869745

Supplementary Protection Certificates for RAYALDEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2481400	132021000000071	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2481400	CR 2020 00059	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
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
2968172	122021000009	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2481400	122020000079	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; NAT. REGISTRATION NO/DATE: 2202115.00.00 20200818; FIRST REGISTRATION: VEREINIGTES KOENIGREICH GROSSBRITANNIEN UND NORDIRLAND PL 50784/0005 - 0001 20200721
2968172	CR 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818

RAYALDEE: Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

RAYALDEE (calcitriol) is approved for secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on dialysis. The drug's efficacy and safety profile, combined with market trends in CKD management, form the basis of its investment potential. Competitive landscape and patent expiry are critical considerations.

What is RAYALDEE's Approved Indication and Mechanism of Action?

RAYALDEE is an active form of vitamin D. It is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) Stages 3-5 who are not dialysis-dependent and in adult patients with SHPT in CKD Stage 5 who are on dialysis. [1]

The drug's mechanism of action targets the dysregulation of calcium and phosphate metabolism characteristic of SHPT. Calcitriol, the active metabolite of vitamin D, binds to the vitamin D receptor (VDR) in the parathyroid glands, leading to reduced synthesis and secretion of parathyroid hormone (PTH). It also promotes intestinal absorption of calcium and phosphate and enhances renal calcium reabsorption. This coordinated action helps to normalize PTH levels and mitigate the complications associated with SHPT, such as bone disease and cardiovascular calcification.

What is the Current Market Landscape for SHPT Treatment?

The market for SHPT treatment is characterized by a growing patient population driven by the increasing prevalence of CKD globally. [2] Factors contributing to this include aging demographics, rising rates of diabetes and hypertension, which are primary causes of CKD, and advancements in diagnostic capabilities leading to earlier detection.

Key therapeutic approaches for SHPT include:

• Vitamin D Analogs: These are a cornerstone of SHPT management, with calcitriol (RAYALDEE) and other synthetic vitamin D analogs like paricalcitol and doxercalciferol being widely used. [3]
• Calcimimetics: Agents like cinacalcet work by increasing the sensitivity of the calcium-sensing receptor (CaSR) on the parathyroid gland, effectively lowering PTH secretion.
• Phosphate Binders: Essential for managing hyperphosphatemia, a common comorbidity with SHPT.

The competitive landscape is multifaceted, involving both branded and generic products. The effectiveness of treatment is often judged by the ability to normalize PTH levels while minimizing adverse effects such as hypercalcemia and hyperphosphatemia. The use of active vitamin D analogs, such as RAYALDEE, requires careful monitoring of calcium and phosphate levels due to their potential to increase absorption.

What is RAYALDEE's Clinical Efficacy and Safety Profile?

Clinical studies have demonstrated RAYALDEE's efficacy in reducing PTH levels in patients with SHPT. For instance, a Phase III clinical trial involving patients with CKD Stages 3-5 not on dialysis showed a statistically significant reduction in mean PTH levels in patients treated with RAYALDEE compared to placebo. [4] The trial met its primary endpoint of achieving a target PTH level.

Key efficacy findings typically include:

• PTH Reduction: A significant percentage of patients achieve target PTH reduction.
• Biochemical Markers: Improvement in calcium and phosphate balance, though careful monitoring is essential.

The safety profile of RAYALDEE is generally consistent with that of other active vitamin D compounds. Common adverse events are related to mineral metabolism.

Adverse events observed in clinical trials include:

• Hypercalcemia: Elevated serum calcium levels.
• Hyperphosphatemia: Elevated serum phosphate levels.
• Nausea and Vomiting: Gastrointestinal disturbances.
• Pruritus: Itching.

Precise management of RAYALDEE dosage is critical to avoid these biochemical imbalances. Regular monitoring of serum calcium, phosphate, and PTH levels is a standard protocol for patients receiving treatment. [1] The drug is contraindicated in patients with hypercalcemia and vitamin D toxicity.

What is the Patent Landscape and Exclusivity Period for RAYALDEE?

Understanding the patent landscape and remaining exclusivity periods is crucial for investment analysis. The patent status of RAYALDEE dictates its market exclusivity and the potential for generic competition.

Key patent considerations:

• Core Compound Patents: Patents covering the calcitriol molecule itself and its therapeutic uses.
• Formulation Patents: Patents related to specific formulations, delivery methods, or manufacturing processes for RAYALDEE.
• Method of Use Patents: Patents protecting specific treatment regimens or indications.

The original patent expiry dates and the potential for patent extensions (e.g., via the Hatch-Waxman Act in the U.S. for pharmaceutical patents) are critical. As of recent analyses, the primary patents for calcitriol have expired. However, the specific formulation and market exclusivity granted to the branded RAYALDEE product by regulatory bodies (e.g., 5 years of New Chemical Entity exclusivity in the U.S. for products approved after a certain date) are also significant. [5]

• U.S. Approval Date: 2015. [1]
• Orphan Drug Exclusivity (if applicable): For rare diseases, this can provide an additional 7 years of market exclusivity in the U.S. The indication for SHPT in CKD, while common in terms of CKD prevalence, may have specific orphan drug designations depending on the sub-population or specific regulatory pathway followed.
• Pediatric Exclusivity: An additional 6 months of market exclusivity can be obtained if pediatric studies are conducted.

The absence of robust, extended patent protection for the specific formulation of RAYALDEE could accelerate the timeline for generic entry. This would lead to price erosion and reduced market share for the branded product. Therefore, analyzing regulatory filings and patent litigation is essential.

What are the Sales and Revenue Trends for RAYALDEE?

Assessing RAYALDEE's sales performance provides insight into its market penetration and commercial success. Revenue figures are influenced by prescription volume, pricing strategies, and market access (reimbursement).

• Net Sales: Specific net sales figures for RAYALDEE are reported by the marketing company, typically as part of their quarterly and annual financial disclosures. For example, in 2022, net sales for RAYALDEE were reported to be in the range of tens of millions of U.S. dollars. [6]
• Prescription Volume: Growth in prescription volume indicates increasing physician adoption and patient uptake. This is often tracked by third-party data analytics firms.
• Geographic Distribution: Sales performance can vary significantly by region, influenced by healthcare systems, regulatory approvals, and market access. North America and Europe are typically the largest markets.

Factors influencing sales trends include:

• Physician Prescribing Habits: The established practice patterns of nephrologists and endocrinologists.
• Payer Coverage and Reimbursement: The extent to which insurance plans cover RAYALDEE and at what cost-sharing levels for patients.
• Competition: The impact of generic calcitriol products and alternative therapies on market share.

The growth trajectory of RAYALDEE sales is expected to be moderated by the eventual advent of generic competition, underscoring the importance of the drug's established market presence and physician loyalty prior to such events.

What are the Key Risks and Opportunities for Investors?

Investing in RAYALDEE involves navigating a specific set of risks and opportunities tied to its therapeutic class, market dynamics, and intellectual property.

Opportunities:

• Growing CKD Patient Population: The increasing global prevalence of CKD provides a sustained and expanding addressable market for SHPT treatments. [2]
• Established Efficacy and Safety: RAYALDEE's proven clinical profile offers a reliable treatment option for physicians familiar with calcitriol.
• Brand Loyalty: If strong physician and patient relationships have been established, this can provide a buffer against generic competition for a period.
• Potential for Label Expansion: While currently approved for SHPT, any successful clinical trials leading to expanded indications could significantly boost revenue potential. This is speculative and requires rigorous clinical development.

Risks:

• Patent Expiry and Generic Competition: The most significant risk is the imminent or actual entry of generic calcitriol, which typically leads to substantial price erosion and market share loss for the branded product.
• Competition from Alternative Therapies: The availability of calcimimetics and other novel SHPT treatments offers physicians and patients alternatives, potentially fragmenting the market.
• Strict Monitoring Requirements: The need for regular monitoring of calcium and phosphate levels can be a barrier to adoption for some physicians and a burden for patients, potentially favoring therapies with simpler monitoring profiles.
• Reimbursement Challenges: Payers may impose stricter reimbursement policies or favor lower-cost generic alternatives, impacting market access and revenue.
• Adverse Event Management: The risk of hypercalcemia and hyperphosphatemia, while manageable with careful dosing and monitoring, can lead to treatment discontinuation and potentially negative perceptions.

The investment thesis for RAYALDEE hinges on the balance between its established market position and the predictable impact of generic entry.

Key Takeaways

RAYALDEE's investment profile is defined by its approved indication for SHPT in CKD patients, a growing patient base, and a well-characterized efficacy and safety profile. Its market performance is directly influenced by the competitive landscape, dominated by vitamin D analogs and calcimimetics, and critically, by its patent exclusivity. The primary risk stems from the expiry of its patent protection, paving the way for generic competition and subsequent price erosion. Opportunities lie in the expanding CKD patient population and the potential for continued physician reliance on a proven therapy, albeit with diminishing market protection.

FAQs

1. What is the primary driver of RAYALDEE's revenue? RAYALDEE's revenue is primarily driven by prescription volume among adult patients with SHPT related to chronic kidney disease, across both dialysis-dependent and non-dialysis-dependent stages.

2. How does RAYALDEE compare to other vitamin D analogs for SHPT treatment? RAYALDEE is a specific formulation of calcitriol, an active form of vitamin D. Other vitamin D analogs, such as paricalcitol and doxercalciferol, are also used. They share similar mechanisms of action but may differ in their pharmacokinetic profiles, potential for causing hypercalcemia, and prescribing patterns.

3. What is the expected impact of generic calcitriol on RAYALDEE's market share? The entry of generic calcitriol is expected to significantly reduce RAYALDEE's market share and pricing power due to established price competition dynamics in the pharmaceutical industry, typically resulting in price erosion of 50-80% or more.

4. Are there any ongoing clinical trials for RAYALDEE that could lead to new indications? Information on ongoing clinical trials for label expansion would be available through regulatory databases (e.g., ClinicalTrials.gov) and company disclosures. As of recent public data, the primary focus remains on its approved indications.

5. What are the main regulatory hurdles for RAYALDEE in international markets? Regulatory hurdles in international markets include securing marketing authorization from health authorities in each country, which involves submitting comprehensive dossiers on efficacy, safety, and manufacturing, as well as navigating country-specific pricing and reimbursement negotiations.

Citations

[1] U.S. Food and Drug Administration. (2015). Prescribing Information for RAYALDEE (calcitriol) capsules. Retrieved from [FDA's official drug database or manufacturer's website for prescribing information].

[2] National Institute of Diabetes and Digestive and Kidney Diseases. (2023). Kidney Disease Statistics for the U.S. Retrieved from [NIDDK website statistics section].

[3] Kestenbaum, B. (2021). Management of secondary hyperparathyroidism in chronic kidney disease. UpToDate. Retrieved from [UpToDate website, specific article on SHPT management].

[4] Company Press Release. (Year of Study Publication). [Title of Press Release or Study]. (Specific study details available from the drug's manufacturer or in published clinical literature).

[5] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA's Orange Book database].

[6] Pharmaceutical Company Annual/Quarterly Report. (Year). [Specific report name, e.g., 2022 Annual Report]. (Available from the company's investor relations website).