RAYOS Drug Patent Profile

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

Rayos is a drug marketed by Horizon and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in RAYOS is prednisone. There are sixteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rayos

A generic version of RAYOS was approved as prednisone by WATSON LABS on December 31^st, 1969.

Summary for RAYOS

International Patents:	53
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	4,570
Drug Prices:	Drug price information for RAYOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RAYOS
What excipients (inactive ingredients) are in RAYOS?	RAYOS excipients list
DailyMed Link:	RAYOS at DailyMed

See drug prices for RAYOS

Pharmacology for RAYOS

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for RAYOS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAYOS	Delayed-release Tablets	prednisone	5 mg	202020	1	2012-11-26

US Patents and Regulatory Information for RAYOS

RAYOS is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012		DISCN	Yes	No	8,309,124
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012		DISCN	Yes	No	9,040,085
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012		DISCN	Yes	No	8,394,407		Y

Expired US Patents for RAYOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	9,040,085
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	9,040,085
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	6,488,960

International Patents for RAYOS

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

Country	Patent Number	Title	Estimated Expiration
Israel	195155	צורת מינון לשחרור מושהה המכילה גלוקוקורטיקואיד ושימושיה לטיפול במחלות ראומטיות (Delayed-release dosage form comprising glucocorticoid and uses thereof in the treatment of rheumatic disease)
Japan	2006524229
Mexico	PA05011446	TABLETA CON LIBERACION RETARDADA CON GEOMETRIA DE NUCLEO DEFINIDA. (DELAYED RELEASE TABLET WITH DEFINED CORE GEOMETRY.)

Market Dynamics and Financial Trajectory for RAYOS

Introduction

RAYOS, a delayed-release formulation of prednisone, was approved by the U.S. Food and Drug Administration (FDA) in 2012 for the treatment of various conditions, including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease (COPD)[4].

Approval and Initial Market Impact

The FDA approval of RAYOS was supported by data from the CAPRA-1 and CAPRA-2 trials, which demonstrated its efficacy in treating moderate to severe rheumatoid arthritis. This approval marked a significant milestone for Horizon Pharma, now part of Amgen, as it expanded their portfolio in rheumatologic diseases[4].

Clinical Data and Differentiation

RAYOS utilizes SkyePharma's proprietary Geoclock™ technology, which provides a delayed-release profile. This formulation allows for the administration of prednisone at 10 p.m. with food, aligning with the natural circadian rhythm of cytokine levels, thereby providing therapeutic benefits during the night when cytokine levels rise[4].

Market Positioning

RAYOS was initially focused on rheumatologic diseases such as rheumatoid arthritis and polymyalgia rheumatica. However, the broad range of approved indications allowed Horizon Pharma to develop a broader commercial strategy, targeting other IL-6 mediated diseases like asthma and COPD[4].

Financial Performance

Early Years

In the initial years following its approval, RAYOS contributed to the growth of Horizon Pharma's rheumatology business unit. While specific financial figures for RAYOS alone are not detailed in the available sources, the rheumatology business unit, which includes RAYOS, saw significant growth. For example, in 2017, the rheumatology business unit of Horizon Pharma, which includes KRYSTEXXA, another key product, grew by 50% year-over-year[5].

Integration with Amgen

Following Amgen's acquisition of Horizon Therapeutics, RAYOS became part of Amgen's expanded portfolio. The acquisition significantly enhanced Amgen's presence in the rare disease and rheumatology markets. In 2023, Amgen reported strong financial performance, with total revenues increasing by 7% to $28.2 billion, driven in part by the inclusion of Horizon-acquired products[3].

Current Financial Trajectory

Product Sales

While specific sales figures for RAYOS are not provided in the recent financial reports, the overall performance of Amgen's product sales, which include RAYOS, has been robust. For the third quarter of 2024, Amgen reported a 24% increase in product sales, driven by 29% volume growth, partially offset by a 2% decline in net selling price[2].

Therapeutic Pillars

RAYOS falls under Amgen's General Medicine therapeutic pillar, one of the four pillars of growth for the company. This pillar, along with Oncology, Inflammation, and Rare Disease, contributes to Amgen's balanced portfolio and growth strategy[3].

Operating Expenses and Margins

The integration of Horizon Therapeutics has led to increased operating expenses for Amgen, including higher royalties and profit share, as well as increased commercial expenses related to the acquired products. However, these expenses are part of Amgen's broader strategy to invest in its pipeline and deliver innovative therapies across its core therapeutic areas[2].

Future Outlook

Given the strong performance of Amgen's portfolio, including the products acquired from Horizon Therapeutics, the outlook for RAYOS remains positive. Amgen anticipates more than a dozen significant pipeline milestones in 2024, which could further enhance the company's market position and financial performance[1].

Key Takeaways

• Approval and Market Impact: RAYOS was approved in 2012 for various rheumatologic and respiratory conditions, marking a significant expansion for Horizon Pharma.
• Clinical Differentiation: RAYOS uses a delayed-release formulation, aligning with the natural circadian rhythm of cytokine levels.
• Financial Performance: While specific figures for RAYOS are not detailed, it contributed to the growth of Horizon Pharma's rheumatology business unit and is now part of Amgen's expanded portfolio.
• Current Trajectory: Amgen's product sales, including those from Horizon-acquired products like RAYOS, have seen significant growth in recent quarters.
• Future Outlook: Amgen's investment in its pipeline and the anticipated milestones suggest a positive future outlook for RAYOS and the broader portfolio.

FAQs

1. What is RAYOS used for? RAYOS is used for the treatment of various conditions including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease (COPD)[4].

2. How does RAYOS differ from immediate-release prednisone? RAYOS uses a delayed-release formulation, allowing for the administration of prednisone at 10 p.m. with food, which aligns with the natural circadian rhythm of cytokine levels[4].

3. Who acquired Horizon Pharma, the original developer of RAYOS? Amgen acquired Horizon Therapeutics, which includes the portfolio of RAYOS[1][2].

4. What are the key therapeutic areas for Amgen, including RAYOS? Amgen's portfolio, including RAYOS, is balanced across four therapeutic pillars: General Medicine, Oncology, Inflammation, and Rare Disease[3].

5. How has the acquisition of Horizon Therapeutics impacted Amgen's financial performance? The acquisition has led to increased product sales and a broader portfolio for Amgen, although it has also resulted in higher operating expenses and changes in earnings mix[2].