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Last Updated: December 22, 2024

CHIRHOSTIM Drug Patent Profile


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

Chirhostim is a drug marketed by Chirhoclin and is included in one NDA.

The generic ingredient in CHIRHOSTIM is secretin synthetic human. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secretin synthetic human profile page.

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Summary for CHIRHOSTIM
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 6
What excipients (inactive ingredients) are in CHIRHOSTIM?CHIRHOSTIM excipients list
DailyMed Link:CHIRHOSTIM at DailyMed
Drug patent expirations by year for CHIRHOSTIM
Recent Clinical Trials for CHIRHOSTIM

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

SponsorPhase
Orlando Health, Inc.Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 1/Phase 2
ChiRhoClin, Inc.N/A

See all CHIRHOSTIM clinical trials

US Patents and Regulatory Information for CHIRHOSTIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chirhoclin CHIRHOSTIM secretin synthetic human FOR SOLUTION;INTRAVENOUS 021256-001 Apr 9, 2004 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chirhoclin CHIRHOSTIM secretin synthetic human FOR SOLUTION;INTRAVENOUS 021256-002 Jun 21, 2007 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

CHIRHOSTIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ChiRhoStim

Introduction

ChiRhoStim, also known as Human Secretin for Injection, is a critical diagnostic drug used primarily for testing pancreatic diseases and cancer. Here, we delve into the market dynamics and financial trajectory of this essential diagnostic tool.

Market Overview

The global synthetic human secretin market, which includes ChiRhoStim, was valued at USD 8.4 million in 2020 and is projected to reach USD 12.7 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period[4].

Diagnostic Uses and Demand

ChiRhoStim is an intravenous product utilized in various diagnostic procedures, including endoscopic retrograde cholangiopancreatography (ERCP) cannulation and gastrinoma testing. The drug has seen unusually high demand, driven by the need for accurate diagnoses of pancreatic cancer, exocrine dysfunction, and other pancreatic disorders[1][3].

Supply Chain and Manufacturing

To address the high demand and prevent potential shortages, ChiRhoClin, Inc. has partnered with PCI Pharma Services. This collaboration has streamlined the production process, with PCI handling sterile drug manufacturing, lyophilization, final testing, and quality assurance release at its Bedford facility, and managing commercial labeling, packaging, and distribution at its Philadelphia site. This partnership has shortened the time to market by approximately three months[1][3].

Financial Incentives and Regulatory Support

The production and distribution of ChiRhoStim benefit from regulatory support. For instance, the FDA's approval process, including the first process performance qualification (PPQ) batch, has been expedited to ensure a stable supply of the drug. Additionally, the orphan drug designation can provide financial incentives such as tax credits, although ChiRhoStim's primary use is not as an orphan drug but as a diagnostic tool[1][3][5].

Market Growth Drivers

Several factors are driving the growth of the synthetic human secretin market:

  • Rising Diagnostic Testing: Increasing demand for diagnostic testing for pancreatic disorders is a significant driver.
  • Growing Disposable Income: Emerging countries with growing disposable incomes are contributing to the market growth.
  • Prevalence of Pancreatic Disorders: The rising prevalence of pancreatic diseases and cancer is another key factor[4].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the synthetic human secretin market due to supply chain disruptions and workspace shutdowns. However, the market is expected to recover as healthcare systems normalize and diagnostic testing resumes[4].

Regional Market Analysis

The market for synthetic human secretin is analyzed across various regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America, particularly the U.S. and Canada, is a significant market due to advanced healthcare infrastructure and high demand for diagnostic procedures[4].

Competitive Landscape

The partnership between ChiRhoClin and PCI Pharma Services highlights the importance of collaborative efforts in maintaining a stable supply of critical diagnostic drugs. PCI's role as a turnkey production partner has been instrumental in expediting the production process and ensuring the drug reaches the market quickly[1][3].

Financial Trajectory

Given the projected market growth, the financial trajectory for ChiRhoStim is positive. Here are some key financial insights:

  • Market Size: The global synthetic human secretin market is expected to grow from USD 8.4 million in 2020 to USD 12.7 million by 2028.
  • Revenue Impact: The streamlined production and distribution process, thanks to the partnership with PCI, will likely contribute to increased revenue for ChiRhoClin.
  • Cost Savings: The expedited production process has saved approximately three months in time to market, which can translate into cost savings and faster revenue realization[1][3][4].

Key Takeaways

  • Growing Demand: High demand for diagnostic testing of pancreatic diseases drives the market.
  • Partnerships: Collaborations like the one between ChiRhoClin and PCI Pharma Services are crucial for maintaining supply and expediting production.
  • Regulatory Support: FDA approvals and potential tax incentives support the market.
  • Regional Growth: North America is a significant market due to its advanced healthcare infrastructure.
  • Financial Growth: The market is projected to grow at a CAGR of 5.6% from 2020 to 2028.

FAQs

Q: What is ChiRhoStim used for? A: ChiRhoStim, or Human Secretin for Injection, is used for diagnosing pancreatic diseases and cancer, including procedures like ERCP cannulation and gastrinoma testing[1][3].

Q: How has the partnership with PCI Pharma Services impacted ChiRhoStim production? A: The partnership has expedited the production process, shortening the time to market by approximately three months and ensuring a stable supply of the drug[1][3].

Q: What are the key drivers of the synthetic human secretin market? A: Rising diagnostic testing for pancreatic disorders, growing disposable income in emerging countries, and the increasing prevalence of pancreatic diseases are key drivers[4].

Q: How did the COVID-19 pandemic affect the synthetic human secretin market? A: The pandemic caused supply chain disruptions and workspace shutdowns, negatively impacting the market, but it is expected to recover as healthcare systems normalize[4].

Q: What is the projected market size for synthetic human secretin by 2028? A: The global synthetic human secretin market is expected to reach USD 12.7 million by 2028, growing at a CAGR of 5.6% from 2020[4].

Sources

  1. PCI Pharma Services Partners with ChiRhoClin to Secure Supply of Critical Diagnostic Drug - PharmaSource Global
  2. 54 Medicare Drugs That Will Be Costing Less Soon - AARP
  3. PCI Pharma Services Partners with ChiRhoClin to Secure Supply of Critical Diagnostic Drug - ChiRhoClin
  4. Synthetic Human Secretin Market Trends, Industry & Size 2030 - Growth Market Reports
  5. Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies - KFF Health News

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