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 seventy-five patent family members in thirty-seven 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:	175
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	1
Patent Applications:	3,257
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

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

Germany

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
European Patent Office	3332773
Portugal	2481400
San Marino	T202000424
Slovenia	1993559

Supplementary Protection Certificates for RAYALDEE

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

Market Dynamics and Financial Trajectory for Rayaldee

Introduction

Rayaldee, a vitamin D3 analogue known as calcifediol, has been approved for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and low serum 25-hydroxyvitamin D levels. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Approval and Indications

Rayaldee was approved by the U.S. Food and Drug Administration (FDA) in June 2016 and by Health Canada in November 2018. The drug is specifically indicated for the treatment of SHPT in adult patients with stage 3 or 4 CKD and serum total 25-hydroxyvitamin D levels less than 30 ng/mL[4][2].

Target Market

The target market for Rayaldee is substantial, given the prevalence of CKD and associated SHPT. In the United States, there are approximately 9 million patients with SHPT, stage 3 or 4 CKD, and vitamin D insufficiency. This large patient population presents a significant market opportunity for Rayaldee[4].

Clinical Efficacy

The approval of Rayaldee was based on two Phase III clinical trials that demonstrated its efficacy in reducing plasma intact parathyroid hormone (iPTH) levels and increasing serum 25-hydroxyvitamin D levels. A larger proportion of patients treated with Rayaldee achieved a 30% reduction in iPTH levels compared to those receiving a placebo[2].

Market Launch and Sales Performance

OPKO Health, the company behind Rayaldee, planned to launch the drug in the U.S. through its dedicated renal sales force in the second half of 2016. The sales performance of Rayaldee has shown steady growth. In the fourth quarter of 2022, revenue from Rayaldee sales was $9.1 million, up from $7.7 million in the prior-year period. By the fourth quarter of 2023, this figure increased to $9.3 million[2][5].

Financial Performance of OPKO Health

The financial performance of OPKO Health, particularly in relation to Rayaldee, reflects the drug's growing market presence. Here are some key financial highlights:

• Revenue Growth: Revenue from Rayaldee has consistently increased, contributing to the overall growth in product sales for OPKO Health. In the fourth quarter of 2023, total product revenue increased to $43.0 million from $37.9 million in the fourth quarter of 2022, partly driven by Rayaldee sales[2].
• Operating Expenses: While OPKO Health has reported operating losses, the company's investments in pre-launch activities, marketing, and research and development have been significant. For instance, in 2022, total costs and expenses were $240.7 million, with a notable portion allocated to selling, general, and administrative expenses, as well as research and development[5].

Competitive Landscape

Rayaldee operates in a niche market focused on treating SHPT in patients with CKD. The competitive landscape is characterized by other treatments for CKD and SHPT, but Rayaldee's unique formulation and efficacy profile set it apart. Vifor Pharma Group, which has a significant presence in nephrology, has also been a key player in this market, further highlighting the competitive dynamics[3].

Growth Strategy

OPKO Health and its partners, such as Vifor Pharma Group, have a strategic focus on driving growth through commercial deals, in-licensed innovation, in-house discovery, and relevant acquisitions. This strategy is aimed at establishing a strong presence in the nephrology market. The launch of Rayaldee and other pipeline products is central to this growth plan[3].

Regulatory and Safety Profile

The regulatory approval process for Rayaldee was rigorous, involving detailed reviews of quality, non-clinical, and clinical data. Health Canada and the FDA have both concluded that Rayaldee has a favourable benefit-risk profile for its intended use. The safety profile of Rayaldee is acceptable, with identified safety issues adequately described in the product monograph and appropriate risk mitigation recommendations included[2].

Patient and Market Impact

Rayaldee has a significant impact on patient care by addressing a critical need in the treatment of SHPT associated with CKD. The drug's ability to raise serum 25-hydroxyvitamin D levels and reduce iPTH levels improves the management of this condition, enhancing patient outcomes.

Future Outlook

Given the growing sales and the expanding patient population with CKD and SHPT, the future outlook for Rayaldee appears promising. Continued investments in marketing and sales efforts, along with the potential for further clinical trials to expand indications, could further bolster the drug's market position.

Key Takeaways

• Market Approval: Rayaldee is approved for treating SHPT in adults with stage 3 or 4 CKD and low serum 25-hydroxyvitamin D levels.
• Clinical Efficacy: Demonstrated efficacy in reducing iPTH levels and increasing serum 25-hydroxyvitamin D levels.
• Sales Performance: Steady growth in sales revenue, with $9.3 million in the fourth quarter of 2023.
• Financial Performance: Contributes to OPKO Health's overall product revenue growth, despite operating losses.
• Competitive Landscape: Operates in a niche market with a unique formulation and efficacy profile.
• Growth Strategy: Part of OPKO Health's and Vifor Pharma Group's broader strategy to dominate the nephrology market.

FAQs

Q: What is Rayaldee used for? A: Rayaldee is used for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and low serum 25-hydroxyvitamin D levels.

Q: Who approved Rayaldee? A: Rayaldee was approved by the U.S. Food and Drug Administration (FDA) in June 2016 and by Health Canada in November 2018.

Q: What are the key clinical benefits of Rayaldee? A: Rayaldee reduces plasma intact parathyroid hormone (iPTH) levels and increases serum 25-hydroxyvitamin D levels, improving the management of SHPT.

Q: How has Rayaldee performed in terms of sales? A: Rayaldee has shown steady growth in sales, with revenue increasing to $9.3 million in the fourth quarter of 2023.

Q: What is the competitive landscape for Rayaldee? A: Rayaldee operates in a niche market focused on treating SHPT in patients with CKD, with Vifor Pharma Group being a significant player in the nephrology market.

Cited Sources

1. Health Canada: Summary Basis of Decision for Rayaldee.
2. OPKO Health: FDA Approves New Drug Application for RAYALDEE® to Treat Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Stage 3-4 Chronic Kidney Disease.
3. Vifor Pharma Group: Annual Report 2019.
4. OPKO Health: OPKO Health Reports Fourth Quarter 2023 Business Highlights and Financial Results.
5. OPKO Health: OPKO Health Reports Fourth Quarter 2022 Business Highlights and Financial Results.