Corticorelin ovine triflutate - Biologic Drug Details

Summary for corticorelin ovine triflutate

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for corticorelin ovine triflutate

Recent Litigation for corticorelin ovine triflutate

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all corticorelin ovine triflutate litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for corticorelin ovine triflutate Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for corticorelin ovine triflutate Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for corticorelin ovine triflutate Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Corticorelin Ovine Triflutate

Introduction

Corticorelin ovine triflutate, marketed under the brand name Acthrel, is a synthetic corticotropin-releasing hormone used primarily for diagnostic purposes in patients with ACTH-dependent Cushing's syndrome. Here, we will delve into the market dynamics and financial trajectory of this biologic drug.

Market Context: Biological Drugs

The global biological drugs market is experiencing robust growth, driven by increasing research and development activities, the rising prevalence of chronic diseases, and a growing demand for personalized medicine. This market was valued at USD 296.2 billion in 2023 and is expected to grow to USD 326.12 billion by 2030, with a compound annual growth rate (CAGR) of 10.1% during the forecast period[4].

Product Overview

Corticorelin ovine triflutate is a synthetic peptide with an amino acid sequence identical to ovine corticotropin-releasing hormone (oCRH) and is an analogue of the naturally occurring human CRH (hCRH) peptide. It is used to differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome[1][2][3].

Market Position

Despite being a niche product, corticorelin ovine triflutate holds a specific position in the therapeutic proteins sub-segment of the biological drugs market. This sub-segment is projected to generate significant revenue, driven by the extensive applications of therapeutic proteins across multiple therapeutic areas[4].

Supply and Demand Dynamics

The market for corticorelin ovine triflutate has been significantly impacted by supply chain issues. Ferring, the sole supplier of Acthrel, discontinued the product in late-September 2020 due to manufacturing sourcing issues. This discontinuation has resulted in a complete shortage of the drug, with no estimated resupply dates[5].

Financial Impact of Discontinuation

The discontinuation of Acthrel has had a profound financial impact on the market. The lack of availability of this diagnostic tool has forced healthcare providers to seek alternative methods for diagnosing ACTH-dependent Cushing's syndrome, potentially increasing costs and complicating patient care. This disruption also affects the revenue streams of healthcare facilities and pharmaceutical companies that relied on this product.

Regulatory Environment

The regulatory environment for biological drugs, including corticorelin ovine triflutate, is stringent and supportive. In the US, for example, the Inflation Reduction Act provides 13-year patent protection for new biologics, incentivizing further investment and innovation in this sector. The FDA's streamlined approval process also facilitates the entry of new biological drugs into the market[4].

Competitive Landscape

The competitive landscape for biological drugs is highly dynamic, with major players like Roche, Novartis, and Amgen driving innovation through novel biologics, strategic collaborations, and expanded indications for existing products. However, the discontinuation of Acthrel has created a gap in the market for diagnostic tools specific to ACTH-dependent Cushing's syndrome, which could be an opportunity for other companies to develop alternative products[4].

Regional Insights

North America, particularly the US, holds a dominant position in the biological drugs market due to its well-developed pharmaceutical industry, access to top-notch healthcare facilities, and widespread insurance coverage. This region's regulatory frameworks and funding for biologic research further support the development and market entry of new biological drugs[4].

Future Outlook

Given the current shortage and discontinuation of Acthrel, the future outlook for corticorelin ovine triflutate is uncertain. However, the broader biological drugs market is expected to continue growing, driven by advancements in biotechnology, increasing demand for personalized medicine, and the rising incidence of chronic diseases. Any potential re-entry or development of similar diagnostic tools would need to address the manufacturing and sourcing issues that led to the discontinuation of Acthrel.

Key Takeaways

• Market Growth: The global biological drugs market is growing, but the specific market for corticorelin ovine triflutate is impacted by supply chain issues.
• Supply Chain Issues: The discontinuation of Acthrel due to manufacturing sourcing issues has created a shortage.
• Regulatory Support: The regulatory environment is supportive of biological drug development.
• Competitive Landscape: The competitive landscape is dynamic, with opportunities for new products to fill the gap left by Acthrel.
• Future Outlook: The future of corticorelin ovine triflutate is uncertain, but the broader market for biological drugs is promising.

FAQs

What is corticorelin ovine triflutate used for?

Corticorelin ovine triflutate, marketed as Acthrel, is used for diagnostic purposes to differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome[1][2][3].

Why was Acthrel discontinued?

Acthrel was discontinued by Ferring in late-September 2020 due to manufacturing sourcing issues[5].

What is the current market size of the biological drugs market?

The global biological drugs market was valued at USD 296.2 billion in 2023 and is expected to grow to USD 326.12 billion by 2030[4].

What are the key drivers of the biological drugs market?

The market is driven by increasing research and development activities, the rising prevalence of chronic diseases, and a growing demand for personalized medicine[4].

How does the regulatory environment impact biological drugs?

The regulatory environment, particularly in the US, is supportive with 13-year patent protection for new biologics and a streamlined FDA approval process, which incentivizes innovation and investment in biological drugs[4].

Sources

1. DrugBank: Corticorelin ovine triflutate: Uses, Interactions, Mechanism of Action.
2. FDA: ACTHREL® (corticorelin ovine triflutate for injection) - Label.
3. RxList: Acthrel (Corticorelin Ovine Triflutate for Injection).
4. Maximize Market Research: Global Biological Drugs Market: Global Industry Analysis.
5. ASHP: Drug Shortage Detail: Corticorelin Ovine Triflutate Injection.

Last updated: 2024-12-21