ROCALTROL Drug Patent Profile

When do Rocaltrol patents expire, and when can generic versions of Rocaltrol launch?

Rocaltrol is a drug marketed by Esjay Pharma and is included in two NDAs.

The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rocaltrol

A generic version of ROCALTROL was approved as calcitriol by TEVA on October 12^th, 2001.

Summary for ROCALTROL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	27
Patent Applications:	4,015
Drug Prices:	Drug price information for ROCALTROL
What excipients (inactive ingredients) are in ROCALTROL?	ROCALTROL excipients list
DailyMed Link:	ROCALTROL at DailyMed

See drug prices for ROCALTROL

See drug sales revenues for ROCALTROL

Recent Clinical Trials for ROCALTROL

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

Sponsor	Phase
RenJi Hospital	N/A
Institut de Recerca Biomèdica de Lleida	Phase 4
Berta Alemany	Phase 4

See all ROCALTROL clinical trials

Pharmacology for ROCALTROL

Drug Class

Vitamin D3 Analog

US Patents and Regulatory Information for ROCALTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Esjay Pharma	ROCALTROL	calcitriol	SOLUTION;ORAL	021068-001	Nov 20, 1998	AA	RX	Yes	Yes

Expired US Patents for ROCALTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	3,697,559
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	4,391,802
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	4,225,596
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	4,391,802
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	4,225,596

International Patents for ROCALTROL

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

Country	Patent Number	Title	Estimated Expiration
Canada	962666	1,25-DIHYDROXYCHOLECALIFEROL
France	2126414
Japan	S57149224	TUMOR-SUPPRESSING AGENT
Netherlands	7202496
United Kingdom	1331011

Market Dynamics and Financial Trajectory of Calcitriol (ROCALTROL)

Introduction

Calcitriol, marketed under the brand name ROCALTROL, is a synthetic form of the active metabolite of vitamin D, playing a crucial role in the regulation of calcium and phosphate levels in the body. This article delves into the market dynamics and financial trajectory of calcitriol, highlighting key drivers, restraints, and future projections.

Global Market Size and Growth

As of 2023, the global calcitriol market was valued at approximately USD 441.62 million to USD 442.53 million, depending on the source[1][3].

• The market is projected to grow to USD 608.42 million by 2032 at a Compound Annual Growth Rate (CAGR) of 3.3% according to one report, while another estimates it to reach USD 679.49 million by 2032 with a CAGR of 4.88%[1][3].

Key Drivers of Market Growth

Increasing Prevalence of Osteoporosis and Bone-Related Diseases

The rising incidence of osteoporosis and other bone-related diseases is a significant driver. Osteoporosis causes over 8.9 million fractures annually worldwide, affecting around 75 million people in Europe, the U.S., and Japan[3][5].

Growing Elderly Population

An aging population, particularly in regions like North America and Europe, contributes to the increased demand for calcitriol. Elderly individuals are more prone to osteoporosis and chronic kidney disease, which require calcitriol for treatment[1][3].

Advancements in Healthcare Infrastructure

The expansion of healthcare facilities and increasing healthcare expenditure, especially in developed regions, are boosting the market. Advanced healthcare infrastructure supports the diagnosis and treatment of conditions requiring calcitriol[3][5].

Patent Expiry and Generic Market Growth

The expiry of patents for branded drugs and the subsequent increase in generic versions are expected to create new opportunities in the calcitriol market. This shift is likely to make calcitriol more accessible and affordable[3][5].

Market Segmentation

By Product Type

• Calcitriol capsules are the dominant product type due to their ease of use. Other forms include calcitriol solutions and injectables[3][5].

By Application

• The primary applications are in the treatment of osteoporosis and renal osteodystrophy. Other applications include hypoparathyroidism and rickets[3][5].

By Distribution Channel

• Hospital pharmacies hold the largest market share due to the need for close supervision by specialists in treating chronic diseases[1].

Regional Analysis

North America

• North America is the most significant market shareholder and is expected to expand substantially during the forecast period. The region's advanced healthcare facilities and high prevalence of osteoporosis and kidney diseases drive this growth[1][3][5].

Europe

• Europe is the second leading region, driven by the presence of advanced research and development facilities and the patent expiry of branded drugs[3][5].

Asia-Pacific

• The Asia-Pacific region is anticipated to be the fastest-growing market, driven by increasing healthcare infrastructure and a growing elderly population[1][3].

Latin America and Middle East & Africa

• These regions are expected to experience moderate growth due to improving healthcare facilities and increasing awareness of vitamin D deficiency[3].

Competitive Landscape

The calcitriol market is competitive, with key players including:

• F. Hoffmann-La Roche Ltd.
• Sun Pharmaceutical Industries Ltd.
• GlaxoSmithKline PLC
• Hikma Pharmaceuticals PLC
• Glenmark Pharmaceuticals
• Akorn, Incorporated
• Strides Pharma Science Limited
• Amneal Pharmaceuticals LLC[3].

Challenges and Restraints

Stringent Regulatory Requirements

The calcitriol market faces challenges from stringent regulatory processes and intellectual property rights. These factors can inhibit market growth and require rigorous quality control measures to maintain investor confidence[1][3][5].

Recent Product Recalls

Recent recalls of certain calcitriol products due to quality issues have also impacted market confidence and necessitate strict adherence to regulatory standards[1].

Financial Performance and Projections

Historical Performance

The global calcitriol market has shown steady growth from 2017, when it was valued at approximately USD 350 million, to 2023, when it reached around USD 441.62 million to USD 442.53 million[1][3][5].

Future Projections

By 2032, the market is expected to reach USD 608.42 million to USD 679.49 million, driven by the factors mentioned above. The CAGR of 3.3% to 4.88% indicates a stable and growing market[1][3].

Key Takeaways

• The calcitriol market is driven by the increasing prevalence of osteoporosis and other bone-related diseases.
• The aging population and advancements in healthcare infrastructure are significant growth factors.
• North America dominates the market, with the Asia-Pacific region expected to be the fastest-growing.
• Stringent regulatory requirements and recent product recalls pose challenges.
• The market is expected to grow at a CAGR of 3.3% to 4.88% from 2024 to 2032.

FAQs

What is the current market size of the global calcitriol market?

The global calcitriol market was valued at approximately USD 441.62 million to USD 442.53 million in 2023[1][3].

What is the projected growth rate of the calcitriol market?

The market is expected to grow at a CAGR of 3.3% to 4.88% from 2024 to 2032[1][3].

Which region dominates the calcitriol market?

North America is the most significant market shareholder and is expected to expand substantially during the forecast period[1][3][5].

What are the main applications of calcitriol?

The primary applications are in the treatment of osteoporosis and renal osteodystrophy, with other applications including hypoparathyroidism and rickets[3][5].

What challenges does the calcitriol market face?

The market faces challenges from stringent regulatory processes, intellectual property rights, and recent product recalls[1][3][5].

Sources

1. Straits Research: Global Calcitriol Market Size to Grow at a CAGR of 3.3% by 2032.
2. AnnualReports.com: Amgen 2007 Annual Report and Financial Summary.
3. Zion Market Research: Calcitriol Market Size, Share, Growth and Forecast 2024 - 2032.
4. MarketScreener: Roche: ambitions set out at Pharma Day 2024.
5. GlobeNewswire: Global Calcitriol Market Expected to Reach USD 470 Million By 2024.