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Last Updated: December 22, 2024

DRISDOL Drug Patent Profile


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

Drisdol is a drug marketed by Esjay Pharma and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Drisdol

A generic version of DRISDOL was approved as ergocalciferol by CHARTWELL RX on May 20th, 2009.

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Summary for DRISDOL
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 5
Patent Applications: 3,434
What excipients (inactive ingredients) are in DRISDOL?DRISDOL excipients list
DailyMed Link:DRISDOL at DailyMed
Drug patent expirations by year for DRISDOL
Drug Sales Revenue Trends for DRISDOL

See drug sales revenues for DRISDOL

Recent Clinical Trials for DRISDOL

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

SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
Satellite HealthcarePhase 4
Albany College of Pharmacy and Health SciencesPhase 4

See all DRISDOL clinical trials

Pharmacology for DRISDOL

US Patents and Regulatory Information for DRISDOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Esjay Pharma DRISDOL ergocalciferol CAPSULE;ORAL 003444-001 Approved Prior to Jan 1, 1982 AA RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DRISDOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DRISDOL

Introduction

DRISDOL, a brand of ergocalciferol (Vitamin D2), is a synthetic calcium regulator used in the treatment of various conditions, including hypoparathyroidism, refractory rickets, and familial hypophosphatemia. To understand the market dynamics and financial trajectory of DRISDOL, it is essential to delve into the broader vitamin D market, the pharmaceutical industry trends, and specific product details.

Global Vitamin D Market Overview

The global vitamin D ingredients market, which includes both Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol), is experiencing significant growth. As of 2022, the market was valued at USD 1426.2 million and is projected to reach USD 2444.52 million by 2029, with a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period[1].

Product Type and Source

DRISDOL falls under the category of Vitamin D2 (ergocalciferol). The market for Vitamin D2, although smaller compared to Vitamin D3, still holds a substantial share. The growth in this segment is driven by increased fortification in food and beverage industries, as well as its use in pharmaceutical and animal health applications[1].

Applications and End-Use Segments

DRISDOL is primarily used in the pharmaceutical sector for treating specific medical conditions. The pharmaceutical application segment of the vitamin D market is one of the key drivers, with a significant market size and growth rate. Additionally, the use of vitamin D in animal health and food and beverages contributes to the overall market expansion[1].

Acquisition and Market Presence

In 2015, Validus Pharmaceuticals acquired the U.S. rights to DRISDOL (ergocalciferol) capsules and oral solution from Sanofi US. This acquisition was part of Validus's strategic plan to expand its presence in the U.S. pharmaceutical market by acquiring well-established products with significant clinical benefits[2].

Market Competition and Entry Barriers

The pharmaceutical market, including the segment for vitamin D products, has seen a reduction in entry barriers over time. This is evident from the decreased period of marketing exclusivity for breakthrough drugs, which has fallen dramatically from a median of 10.2 years in the 1970s to 1.2 years in the late 1990s. This increased competitiveness suggests that follow-on drugs, like DRISDOL, can enter the market more quickly, providing more therapeutic options and price competition[3].

Financial Performance and Growth

While specific financial data for DRISDOL is not publicly disclosed, the overall growth of the vitamin D market and the strategic acquisitions by companies like Validus Pharmaceuticals indicate a positive financial trajectory. The acquisition of DRISDOL by Validus is expected to generate significant sales and contribute to the company's growth in the pharmaceutical market[2].

Regulatory and Safety Considerations

DRISDOL is subject to strict regulatory and safety guidelines. It is contraindicated in patients with hypercalcemia, malabsorption syndrome, and hypersensitivity to vitamin D. The dosage must be individualized under close medical supervision, highlighting the need for careful management to avoid toxicity[4].

Pediatric and Geriatric Use

The use of DRISDOL in pediatric and geriatric populations requires careful consideration. Pediatric doses must be individualized, and for geriatric patients, dose selection should be cautious due to potential decreased hepatic, renal, or cardiac function[4].

Key Takeaways

  • Market Growth: The global vitamin D ingredients market, including DRISDOL, is expected to grow significantly, driven by increased fortification in food and beverages and pharmaceutical applications.
  • Acquisition and Market Presence: Validus Pharmaceuticals' acquisition of DRISDOL has expanded its market presence in the U.S. pharmaceutical sector.
  • Regulatory and Safety: Strict regulatory and safety guidelines are in place for the use of DRISDOL, emphasizing the need for careful medical supervision.
  • Competitive Landscape: The pharmaceutical market has become more competitive, with reduced entry barriers for follow-on drugs.

FAQs

Q: What is DRISDOL used for? A: DRISDOL is used in the treatment of hypoparathyroidism, refractory rickets, and familial hypophosphatemia.

Q: Who acquired the U.S. rights to DRISDOL? A: Validus Pharmaceuticals acquired the U.S. rights to DRISDOL from Sanofi US in 2015.

Q: What is the expected growth rate of the global vitamin D ingredients market? A: The global vitamin D ingredients market is expected to grow at a CAGR of 8.2% from 2022 to 2029.

Q: What are the contraindications for DRISDOL? A: DRISDOL is contraindicated in patients with hypercalcemia, malabsorption syndrome, and hypersensitivity to vitamin D.

Q: How is the dosage of DRISDOL managed? A: The dosage of DRISDOL must be individualized under close medical supervision, with regular monitoring of blood calcium and phosphorus levels.

Sources

  1. Global Vitamin D (D2, D3) Ingredients Market Analysis - GlobeNewswire
  2. Validus Pharmaceuticals Further Expands Marketed U.S. Portfolio - PR Newswire
  3. The economics of follow-on drug research and development - PubMed
  4. Drisdol: Package Insert / Prescribing Information - Drugs.com

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