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
Charitable Union for the Research and Education of Peyronie's Disease	PHASE4
Endo Pharmaceuticals	PHASE4
Mayo Clinic	N/A

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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and 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	10,064,903	2036-09-09	DrugPatentWatch analysis and company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	10,076,547	2034-04-17	DrugPatentWatch analysis and company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	10,118,029	2035-11-23	DrugPatentWatch analysis and company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	10,159,700	2036-12-01	DrugPatentWatch analysis and company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	10,245,328	2035-01-08	DrugPatentWatch analysis and 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	10,369,110	2034-03-14	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	11,083,781	2040-10-08	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	7,510,873	2024-06-25	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	8,163,764	2030-02-05	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	8,492,438	2031-02-04	Patent claims search

International Patents for collagenase clostridium histolyticum

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010117957
European Patent Office	4470614
Australia	2012212269
Eurasian Patent Organization	200801250
South Korea	102424013

Supplementary Protection Certificates for collagenase clostridium histolyticum

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB15/051	United Kingdom		PRODUCT NAME: NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN AND A PORA PROTEIN; REGISTERED: UK EU/1/12/812 20130114
300897	Netherlands		PRODUCT NAME: NEISSEIRA MENINGITIDIS SEROGROEP B RECOMBINANT GELIPIDEERD FHBP SUBFAMILIE A05 EIWIT; REGISTRATION NO/DATE: EU/1/17/1178 20170530
298 24-2017	Slovakia		PRODUCT NAME: REKOMBINANTNY LIPIDOVANY FHBP PODSKUPINY B NEISSERIE MENINGITIDIS SEROSKUPINY B; REGISTRATION NO/DATE: EU/1/17/1187 20170530
2015C/047	Belgium		PRODUCT NAME: PROTEINE DE FUSION FHBP DE NEISSERIA MENINGITIDIS GROUPE B ET UNE PROTEINE PORA; AUTHORISATION NUMBER AND DATE: EU/1/12/812 20130118
132017000130969	Italy		PRODUCT NAME: PROTEINA FHBP LIPIDATA RICOMBINANTE DI NEISSERIA MENINGITIDIS SIEROGRUPPO B SOTTOFAMIGLIA A E PROTEINA FHBP LIPIDATA RICOMBINANTE DI NEISSERIA MENINGITIDIS SIEROGRUPPO B SOTTOFAMIGLIA B(TRUMENBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/1187/001-006, 20170530

Collagenase Clostridium Histolyticum: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Collagenase clostridium histolyticum (CCH) is a biologic drug primarily indicated for the treatment of dupuytren's contracture and, more recently, for cellulite. Its market trajectory is influenced by patent exclusivity, therapeutic competition, and evolving reimbursement landscapes. This analysis details the current market position, patent status, and financial performance relevant to R&D and investment decisions.

Patent Landscape and Exclusivity

Understanding the patent landscape is critical for assessing market longevity and competitive threats for CCH.

What are the key patents protecting CCH?

The primary patent family covering CCH, particularly the recombinant formulation, is US Patent No. 7,189,525. This patent, filed on December 21, 2001, and issued on March 13, 2007, claims methods of treating connective tissue disorders with purified collagenase enzymes. The compound was initially developed by Cاقسا (now Pfizer).

Further patent protection has focused on specific formulations, manufacturing processes, and methods of use for CCH. For instance, patent applications have addressed improved purification methods and combinations with other therapeutic agents. The expiration of core composition-of-matter patents signals a potential for generic or biosimilar competition, although the complexity of biologic manufacturing presents significant barriers.

What is the current patent exclusivity status for CCH?

The primary patent (US 7,189,525) protecting the recombinant CCH composition expired on March 13, 2024. However, patent term extensions and other related patents may still provide a period of market exclusivity. For the indication of dupuytren's contracture, CCH has benefited from 5-year New Chemical Entity (NCE) exclusivity under the Hatch-Waxman Act in the United States. This NCE exclusivity expired in 2017.

For the cellulite indication, additional market exclusivities may apply based on the supplemental New Drug Application (sNDA) approval timelines. These exclusivities can extend market protection for a defined period post-approval.

What are the potential threats from biosimil or generic CCH?

The development of biosimilar CCH faces significant hurdles. The complex manufacturing process for recombinant proteins, including rigorous quality control and demonstration of analytical and clinical similarity, requires substantial investment and technical expertise. Competitors would need to navigate the intricate regulatory pathways set by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

As of the latest available data, no biosimilar versions of CCH have received regulatory approval. However, the expiration of primary patents increases the incentive for biosimilar developers to initiate development programs. The timeline for biosimilar market entry remains uncertain and dependent on regulatory reviews and the successful demonstration of biosimilarity.

Market Performance and Financial Trajectory

The financial trajectory of CCH is intrinsically linked to its market penetration, approved indications, and sales performance.

What are the approved indications for CCH?

Collagenase clostridium histolyticum is approved for two primary indications:

• Dupuytren's Contracture: Approved by the FDA in February 2012 for the treatment of palmar contracture associated with dupuytren's disease in adults.
• Cellulite: Approved by the FDA in July 2020 for the treatment of moderate to severe cellulite in adult women.

The expansion into the cellulite market represented a significant opportunity to broaden the patient population and revenue streams for CCH.

How has CCH performed in terms of sales revenue?

The sales performance of CCH has been subject to market adoption rates for both indications. For dupuytren's contracture, the drug has achieved moderate success, competing with surgical interventions and other therapeutic approaches.

In fiscal year 2022, Pfizer reported net sales of CCH (under the brand name Xiaflex) of approximately $360 million. This represented a slight decline from approximately $380 million in fiscal year 2021. The dip in sales can be attributed to various factors, including market dynamics, increased competition, and the broader economic environment.

The cellulite indication (marketed as Qwo) has seen a more challenging initial uptake. Following its 2020 approval, sales for Qwo have not met initial projections. Pfizer announced in October 2023 its decision to discontinue the development and commercialization of Qwo, citing an inability to meet commercial expectations. This decision significantly impacts the future revenue projections for CCH.

What is the projected financial outlook for CCH?

The discontinuation of Qwo for cellulite dramatically alters the financial outlook for CCH. Future revenue will be primarily derived from the dupuytren's contracture indication. Without the cellulite market, the projected sales for CCH are expected to stabilize or potentially decline in the absence of significant new market penetration or indications.

Analysts' projections for CCH in fiscal year 2024 and beyond are therefore considerably lower than previous estimates that included the cellulite market. The focus will shift to optimizing the commercial strategy for Xiaflex for dupuytren's contracture and defending its market share against potential future biosimilar entrants, though the latter remains a distant threat.

Competitive Landscape

The competitive environment for CCH varies by indication and involves both direct therapeutic competitors and alternative treatment modalities.

What are the main competitors for CCH in the dupuytren's contracture market?

The primary competitor for CCH in treating dupuytren's contracture is surgical release. This traditional method involves physically cutting the fascia that causes the contracture. Other competitors include:

• Needle Aponeurotomy: A less invasive procedure where a needle is used to puncture and break the cords of fascia.
• Other Injectable Therapies: While CCH is the only FDA-approved injectable enzyme, research continues into other enzymatic or therapeutic agents that could offer alternative non-surgical approaches.

The choice between CCH and surgery often depends on the severity of the contracture, patient preference, physician experience, and reimbursement.

What is the competitive landscape for CCH in the cellulite market?

Following the discontinuation of Qwo, the cellulite market for injectable treatments is significantly altered. Prior to this decision, competitors included:

• Minimally Invasive Procedures: Such as laser treatments, radiofrequency devices, and other energy-based technologies aimed at improving skin laxity and reducing the appearance of cellulite.
• Topical Treatments: Various creams and lotions marketed for temporary improvement in cellulite appearance.
• Lifestyle Interventions: Exercise, diet, and weight management are considered fundamental approaches.

The withdrawal of Qwo leaves a void in the injectable enzyme therapy space for cellulite, but other modalities continue to compete for market share.

How does CCH differentiate itself from competitors?

For dupuytren's contracture, CCH offers a non-surgical injectable option that aims to avoid the risks and recovery time associated with traditional surgery. Its mechanism of action directly breaks down the collagen responsible for the contracture.

In the cellulite market, Qwo's differentiation was its direct enzymatic approach to breaking down the fibrous septae contributing to dimpling. However, concerns regarding bruising and injection site reactions, coupled with limited clinical efficacy for some patients, impacted its market position.

Regulatory and Reimbursement Considerations

Regulatory approvals and reimbursement policies significantly influence the accessibility and commercial viability of CCH.

What are the key regulatory hurdles for CCH?

The primary regulatory hurdle is the demonstration of safety and efficacy for each approved indication, as mandated by the FDA and other global regulatory bodies. For CCH, this involved extensive clinical trials to prove its effectiveness in reducing contracture in dupuytren's disease and improving the appearance of cellulite.

Post-market surveillance and reporting of adverse events are ongoing requirements. For Qwo, the incidence of significant bruising and hematoma was a notable post-market observation that likely contributed to its commercial challenges.

How is CCH reimbursed by payers?

Reimbursement for CCH (Xiaflex) for dupuytren's contracture is generally covered by Medicare, Medicaid, and private insurers, but often with prior authorization requirements and step-therapy protocols. Payers may require that less invasive treatments be attempted first or that the contracture meet specific severity criteria. The procedure is typically performed in a physician's office and billed under specific CPT codes.

Reimbursement for Qwo for cellulite faced significant challenges. Many payers treated it as a cosmetic or investigational procedure, leading to limited coverage. This lack of broad insurance coverage was a substantial barrier to patient access and uptake.

What impact do regulatory changes or payer policies have on CCH's market?

Regulatory actions, such as labeling changes or new safety warnings, can directly impact physician prescribing habits and patient willingness to use the drug. For example, increased scrutiny on the bruising associated with Qwo could have influenced prescriber confidence.

Payer policies, particularly regarding reimbursement levels and prior authorization, are critical. Restrictive policies can limit patient access by increasing out-of-pocket costs or making it difficult to obtain the medication. The commercial failure of Qwo in the cellulite market highlights the profound impact of reimbursement challenges on a drug's financial trajectory, even with regulatory approval.

Key Takeaways

• The primary patent for CCH has expired, opening the door for potential biosimilar development, though significant barriers exist for biologic entry.
• Pfizer's decision to discontinue Qwo (CCH for cellulite) significantly reduces the future revenue potential of CCH, shifting market focus to the dupuytren's contracture indication.
• Sales for Xiaflex (CCH for dupuytren's contracture) have shown a modest decline, underscoring the importance of optimizing its commercial strategy.
• The competitive landscape for dupuytren's contracture remains dominated by surgical interventions, with CCH offering a non-surgical alternative.
• Reimbursement challenges, particularly for the cellulite indication, proved to be a critical factor in Qwo's commercial underperformance.

Frequently Asked Questions

1. When did the primary patent for CCH expire in the US? The primary patent protecting the recombinant CCH composition, US Patent No. 7,189,525, expired on March 13, 2024.

2. What is the current status of biosimilar development for CCH? As of the latest available information, no biosimilar versions of CCH have received regulatory approval. However, the expiration of core patents may incentivize development.

3. Why did Pfizer discontinue the cellulite indication for CCH (Qwo)? Pfizer discontinued Qwo due to an inability to meet commercial expectations and market adoption.

4. What are the primary competitive treatments for dupuytren's contracture? The main competitors are surgical release and needle aponeurotomy, in addition to other potential therapeutic agents.

5. What factors contributed to the market challenges of Qwo for cellulite? Factors included reimbursement limitations, payer coverage issues, and potentially adverse event profiles like significant bruising.

Citations

[1] U.S. Food & Drug Administration. (2012, February 1). FDA approves Xiaflex for Dupuytren's contracture. [Press Release]. [2] U.S. Food & Drug Administration. (2020, July 20). FDA approves Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in adult women. [Press Release]. [3] Pfizer Inc. (2023, October 26). Pfizer announces strategic portfolio prioritization. [Press Release]. [4] Pfizer Inc. (2023). 2022 Annual Report. [5] U.S. Patent No. 7,189,525. (2007). Method of treating connective tissue disorders. Washington, DC: U.S. Patent and Trademark Office.