CALDEROL Drug Patent Profile

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

Calderol is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in CALDEROL 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.

Summary for CALDEROL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	138
Patent Applications:	3,260
DailyMed Link:	CALDEROL at DailyMed

US Patents and Regulatory Information for CALDEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CALDEROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982

International Patents for CALDEROL

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

Country	Patent Number	Title	Estimated Expiration
Germany	1933375	25-HYDROXYVERBINDUNGEN DER VITAMIND-REIHE, VERFAHREN ZU IHRER HERSTELLUNG UND 25-HYDROXYCHOLECALCIFEROL ENTHALTENDES MITTEL
Belgium	747492
Italy	1052283	PROCESSO PER PREPARARE COMPOSTI DEL CALCIFEROLO E RELATIVI COMPOSTI
United Kingdom	1261292
Canada	970362	PROCESS FOR PREPARING 25-HYDROXYCHOLECALCIFEROL
Switzerland	533610	Verfahren zur Herstellung von 5,7-Cholestadien-3B,25-diol und Verwendung desselben
Netherlands	6910023

Supplementary Protection Certificates for CALDEROL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481400	C202130022	Spain		PRODUCT NAME: CALCIFEDIOL; NATIONAL AUTHORISATION NUMBER: 85519-DE/H/5590/001/DC; DATE OF AUTHORISATION: 20201230; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE/H/5590/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20200721
2968172	CA 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
2968172	132021000000074	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
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
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
2481400	132021000000071	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
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

CALDEROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oncology Drugs: A Case Study

Introduction

The oncology drugs market is one of the most dynamic and rapidly growing segments within the pharmaceutical industry. This article will delve into the market dynamics and financial trajectory of oncology drugs, using the broader market trends as a backdrop to understand the potential for specific drugs like CALDEROL.

Global Oncology Drugs Market Overview

The global oncology drugs market is projected to expand significantly, driven by several key factors. As of 2024, the market is valued at $231.56 billion and is expected to reach $532.91 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 12.6% during the forecast period[1].

Market Drivers

• Increasing Prevalence of Cancer: Cancer is the second leading cause of death globally, with 9.6 million deaths in 2018 and an estimated 29.5 million new cases and 16.5 million deaths by 2040, according to the International Agency for Research on Cancer (IARC)[1].
• Advancements in Targeted Therapies: The development of targeted therapies and immunotherapies has significantly improved treatment outcomes, reducing side effects and increasing efficacy. This has boosted the demand for these innovative drugs[1].
• Growing Awareness and Treatment Options: Increased awareness about cancer and its treatments has led to higher demand for oncology drugs.

Market Segmentation

• By Drug Class: Cytotoxic drugs currently dominate the market but are expected to be surpassed by targeted therapies by 2031. Targeted therapies are gaining traction due to their higher efficacy and lower side effects[1].
• By Therapy: Chemotherapy is the current leader, but targeted therapy and immunotherapy segments are expected to exhibit significant growth due to novel mechanisms and drugs[1].
• By Geography: North America, Europe, and the Asia Pacific are key regions driving the market growth, with the U.S. and China being significant contributors[1].

Financial Trajectory

The financial trajectory of the oncology drugs market is robust, with several indicators pointing to sustained growth:

• Revenue Forecast: The market is expected to more than double from $231.56 billion in 2024 to $532.91 billion by 2031[1].
• CAGR: A CAGR of 12.6% during the forecast period highlights the rapid expansion of this market[1].
• Investment Trends: Investors, such as pension funds like CalSTRS, are showing strong returns in healthcare and pharmaceutical sectors, indicating a favorable investment climate for oncology drugs[2].

Challenges and Constraints

Despite the positive outlook, there are several challenges:

• High Development Costs: The cost of developing new oncology drugs is extremely high, which can be a significant barrier to entry for new players[1].
• Stringent Government Regulations: Regulatory hurdles can slow down the approval process for new drugs, affecting their market entry and adoption[1].

Impact of Technological Advancements

Technological advancements, such as Next-Generation Sequencing (NGS), are revolutionizing the field of oncology. NGS technologies are expected to grow from $1.3 billion in 2023 to $2.9 billion by 2028, with a CAGR of 17.7%, driving precision medicine and individualized treatment plans for cancer patients[3].

Market Trends and Future Outlook

• Precision Medicine: The shift towards precision medicine is driving the demand for targeted therapies and personalized treatment plans.
• Immunotherapy: Immunotherapies are gaining traction due to their potential in treating various types of cancers.
• Geographical Expansion: Emerging markets in the Asia Pacific and Latin America are expected to contribute significantly to the growth of the oncology drugs market.

Case Study: CALDEROL

While specific data on CALDEROL is not available, its success would likely be tied to the broader trends in the oncology drugs market:

• Innovation: If CALDEROL is a targeted therapy or immunotherapy, it would benefit from the growing demand for these types of treatments.
• Efficacy and Safety: Demonstrating higher efficacy and reduced side effects would align with market preferences and drive adoption.
• Regulatory Approval: Navigating stringent regulatory processes efficiently would be crucial for its market entry and success.
• Market Penetration: Strong marketing and distribution strategies would be necessary to penetrate the market effectively.

Key Takeaways

• The oncology drugs market is driven by the increasing prevalence of cancer and advancements in targeted therapies.
• The market is expected to grow significantly, with a CAGR of 12.6% from 2024 to 2031.
• Technological advancements like NGS are transforming the field of oncology.
• High development costs and stringent regulations are key challenges.
• Precision medicine and immunotherapy are emerging trends.

FAQs

Q: What is the projected value of the global oncology drugs market by 2031? A: The global oncology drugs market is projected to reach $532.91 billion by 2031[1].

Q: What are the primary drivers of the oncology drugs market? A: The primary drivers include the increasing prevalence of cancer, advancements in targeted therapies, and growing awareness about cancer treatments[1].

Q: Which segment is expected to dominate the oncology drugs market by 2031? A: The targeted therapy segment is expected to emerge as the largest segment by 2031[1].

Q: How do technological advancements like NGS impact the oncology drugs market? A: NGS technologies are driving precision medicine and individualized treatment plans, contributing to the growth of the market[3].

Q: What are the major challenges faced by the oncology drugs market? A: High development costs and stringent government regulations are significant challenges[1].

Cited Sources

1. Coherent Market Insights, "Oncology Drugs Market to Reach USD 532.91 Billion by 2031".
2. CalSTRS, "CalSTRS earns 8.4% net return, exceeds benchmark in fiscal year 2023-24".
3. Synapse, "Sealed Air Corp. - Drug pipelines, Patents, Clinical trials - Synapse".
4. IQVIA, "The Use of Medicines in the U.S. 2024: Usage and Spending".