Collagenase clostridium histolyticum - Biologic Drug Details

Summary for collagenase clostridium histolyticum

Tradenames:	1
High Confidence Patents:	3
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for collagenase clostridium histolyticum

Recent Clinical Trials for collagenase clostridium histolyticum

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Mayo Clinic	N/A
Endo Pharmceuticals	Phase 3
Foundation for Orthopaedic Research and Education	Phase 3

See all collagenase clostridium histolyticum clinical trials

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 collagenase clostridium histolyticum Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for collagenase clostridium histolyticum Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2039-03-29	Company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2026-01-30	Company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2039-02-26	Company disclosures

3) Low Certainty: US Patents for collagenase clostridium histolyticum Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2033-03-15	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2040-10-08	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2023-06-27	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338		2022-04-26	Patent claims search

International Patents for collagenase clostridium histolyticum

Country	Patent Number	Estimated Expiration
Australia	2007211313
Brazil	PI0708017
Denmark	40398
European Patent Office	2474320

Market Dynamics and Financial Trajectory for Collagenase Clostridium Histolyticum

Introduction to Collagenase Clostridium Histolyticum

Collagenase Clostridium histolyticum, commonly known by its brand name XIAFLEX, is a biologic drug that has gained significant attention in recent years due to its efficacy in treating various fibrotic conditions. This enzyme, derived from the bacterium Clostridium histolyticum, is used to break down collagen, a protein that, when excessively deposited, can lead to conditions such as Dupuytren's contracture and Peyronie's disease.

Market Size and Growth Projections

The market for collagenase Clostridium histolyticum is experiencing robust growth. As of 2023, the market was valued at USD 420.2 million and is projected to reach USD 680.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2031[1].

Another forecast indicates that the market is estimated to reach $725.93 million by 2030, growing at a CAGR of 3.20% during the forecast period 2024-2030[4].

Driving Factors

Several factors are driving the growth of this market:

Increasing Prevalence of Fibrotic Diseases

The rising incidence of diseases such as Dupuytren's contracture and Peyronie's disease is a significant driver. These conditions are becoming more prevalent, especially among older populations, which is expected to increase demand for effective treatments like collagenase Clostridium histolyticum[1][4].

Growing Acceptance of Minimally Invasive Procedures

The increasing acceptance and preference for minimally invasive cosmetic and medical procedures are boosting the demand for collagenase-based treatments. These procedures are less risky and offer quicker recovery times compared to traditional surgical methods[1].

Advances in Biotechnology

Continuous research and advancements in biotechnology are improving the safety and efficacy of collagenase Clostridium histolyticum. These improvements are enhancing the drug's market appeal and expanding its potential applications[1].

Expanding Indications

Beyond its current uses, collagenase Clostridium histolyticum is being explored for additional indications such as uterine fibroids and cellulite. This expansion into new therapeutic areas is expected to further drive market growth[3].

Geographic Segmentation

The market for collagenase Clostridium histolyticum is segmented geographically, with North America holding the largest share. In 2021, North America accounted for 36% of the overall market, driven by the high prevalence of conditions like Dupuytren's contracture and Peyronie's disease in this region. The aging population in countries like the U.S. is also a significant factor, as the number of older adults is expected to increase substantially by 2050[4].

Financial Performance and Revenue Growth

XIAFLEX, the branded version of collagenase Clostridium histolyticum, has shown consistent revenue growth driven by increased net selling prices and demand. The Branded Pharmaceuticals segment, which includes XIAFLEX, is a key revenue driver for Endo International plc. Despite overall revenue declines, Endo has managed to increase its Adjusted EBITDA through cost reductions and margin improvements[3].

Challenges and Limitations

Despite the positive growth trajectory, the market faces several challenges:

Side Effects and Adverse Events

The administration of collagenase Clostridium histolyticum can lead to various side effects, including bleeding, inflammation, redness, cracked skin, and erectile dysfunction. A significant percentage of patients have reported treatment-related adverse events, which can deter some potential users[4].

Economic Impact of COVID-19

The COVID-19 pandemic has had a detrimental effect on the global economy, leading to increased unemployment and reduced purchasing power. This economic downturn has hindered the growth of the collagenase Clostridium histolyticum market as people are less likely to make non-essential medical expenditures[4].

Generic Competition

As patents for XIAFLEX expire, the market is expected to face competition from biosimilar products. This competition could impact the revenue and market share of the branded product[3].

Future Outlook and Strategic Initiatives

Endo International plc is actively pursuing strategic initiatives to maintain and grow its market position. These include:

Phase 3 Clinical Trials for New Indications

Endo has announced positive results from a Phase 2 clinical study of collagenase Clostridium histolyticum for the treatment of plantar fibromatosis. The company plans to proceed with Phase 3 development, aiming to provide the first non-surgical treatment for this condition[5].

Cost Reduction and Debt Repricing

To improve financial flexibility, Endo has implemented cost reduction and debt repricing strategies. These measures are intended to mitigate the impact of generic competition and economic challenges[3].

Key Takeaways

• Market Growth: The collagenase Clostridium histolyticum market is expected to grow significantly, driven by increasing prevalence of fibrotic diseases and advancements in biotechnology.
• Geographic Dominance: North America holds the largest market share due to high disease prevalence and an aging population.
• Financial Performance: XIAFLEX has shown consistent revenue growth, but faces challenges from generic competition and economic downturns.
• Future Indications: The drug is being explored for new indications such as uterine fibroids and cellulite.
• Challenges: Side effects and adverse events, along with economic impacts of COVID-19, are significant challenges.

FAQs

Q: What is collagenase Clostridium histolyticum used for? A: Collagenase Clostridium histolyticum is used to treat fibrotic conditions such as Dupuytren's contracture and Peyronie's disease by breaking down excess collagen.

Q: What is the projected market size for collagenase Clostridium histolyticum by 2031? A: The market is expected to reach USD 680.5 million by 2031, growing at a CAGR of 4.8% from 2024 to 2031[1].

Q: Which region holds the largest share of the collagenase Clostridium histolyticum market? A: North America holds the largest share, driven by the high prevalence of relevant diseases and an aging population[4].

Q: What are the common side effects associated with collagenase Clostridium histolyticum? A: Common side effects include bleeding, inflammation, redness, cracked skin, and erectile dysfunction[4].

Q: Is collagenase Clostridium histolyticum being explored for new indications? A: Yes, it is being explored for additional indications such as uterine fibroids, cellulite, and plantar fibromatosis[3][5].

Sources

1. Marketresearchintellect: Collagenase Clostridium Histolyticum Market Size And Forecast[1]
2. PubMed: Collagenase clostridium histolyticum for the treatment of Dupuytren's contracture[2]
3. DrugPatentWatch: When do the XIAFLEX patents expire, and when will biosimilar competition begin?[3]
4. IndustryArc: Collagenase Clostridium Histolyticum Market Report, 2024-2030[4]
5. PR Newswire: Endo Provides Top-Line Results from Phase 2 Study of Collagenase Clostridium Histolyticum (CCH) in Participants with Plantar Fibromatosis[5]