PROCARBAZINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for procarbazine hydrochloride and what is the scope of patent protection?

Procarbazine hydrochloride is the generic ingredient in one branded drug marketed by Leadiant Biosci Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for procarbazine hydrochloride. One supplier is listed for this compound.

Summary for PROCARBAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	93
What excipients (inactive ingredients) are in PROCARBAZINE HYDROCHLORIDE?	PROCARBAZINE HYDROCHLORIDE excipients list
DailyMed Link:	PROCARBAZINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PROCARBAZINE HYDROCHLORIDE

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

Sponsor	Phase
Cooperative Trials Group for Neuro-Oncology (COGNO)	PHASE3
Canadian Cancer Trials Group	PHASE3
European Organisation for Research and Treatment of Cancer - EORTC	PHASE3

See all PROCARBAZINE HYDROCHLORIDE clinical trials

Pharmacology for PROCARBAZINE HYDROCHLORIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for PROCARBAZINE HYDROCHLORIDE

Antineoplastic Agents

Anatomical Therapeutic Chemical (ATC) Classes for PROCARBAZINE HYDROCHLORIDE

L01XB	Methylhydrazines
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PROCARBAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for PROCARBAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Procarbazine Hydrochloride

Last updated: July 30, 2025

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Introduction

Procarbazine hydrochloride (Procarbazine HCl) is an alkylating agent primarily used in oncology for the treatment of Hodgkin’s lymphoma and certain brain tumors. Despite its established clinical efficacy, the drug’s market trajectory is influenced by evolving therapeutic paradigms, regulatory landscapes, and competitive dynamics. This analysis delineates the current market landscape, the key factors shaping Procarbazine hydrochloride's financial trajectory, and strategic considerations for stakeholders.

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Market Overview and Therapeutic Positioning

Procarbazine HCl has been part of combination chemotherapy regimens, notably in ABVD protocol (Adriamycin, Bleomycin, Vinblastine, Dacarbazine), for Hodgkin's lymphoma since the 1960s. Its utility extends into salvage therapies and specific brain tumor treatments. However, evolving standards of care, especially with the advent of targeted therapies and immunotherapies, have affected its market share.

Existing Market Size:
Global oncology drug markets are projected to grow at a compound annual growth rate (CAGR) of approximately 7% over the next five years, driven by rising cancer incidence and expanding treatment options [1]. Procarbazine's niche remains relatively specialized, with sales concentrated in regions with established healthcare infrastructure, notably North America and Europe.

Market Segments and Revenue Drivers:

• Hodgkin’s lymphoma treatment: The primary revenue source; however, the increasing adoption of novel agents like Brentuximab Vedotin and PD-1 inhibitors challenge its dominance.
• Brain tumors and rare cancers: Limited but significant segment; ongoing research may expand its indications.

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Key Market Dynamics Influencing Financial Trajectory

1. Therapeutic Landscape and Competitive Pressures

The oncology sector is witnessing a paradigm shift, favoring targeted therapies with improved safety profiles over alkylating agents like procarbazine. The emergence of agents such as brentuximab vedotin and immune checkpoint inhibitors has reduced reliance on traditional chemotherapeutics, consequently impacting sales of older drugs [2].

Impact:
Procarbazine’s market share is declining, with some regions experiencing patent expirations and increased generic availability, exerting downward pressure on prices and margins.

2. Regulatory and Patent Environment

Procarbazine hydrochloride is generally off-patent, leading to increased generic manufacturing which lowers drug prices globally. However, regulatory hurdles in emerging markets and the necessity for ongoing formulation approvals influence market access.

Future Outlook:
Potential regulatory restrictions due to toxicity concerns or adverse event profiles may limit usage, impacting sales volumes.

3. Clinical Trials and New Indications

Ongoing trials exploring procarbazine’s efficacy in novel combinations or as part of targeted therapies may influence its market trajectory positively. For instance, studies assessing its integration with checkpoint inhibitors could revive interest in its clinical application [3].

Outcome:
Successful trials might lead to label expansions, regulatory approvals, and renewed commercial interest, boosting revenues.

4. Manufacturing and Supply Chain Factors

Production costs are stabilized by generic manufacturers, but quality control and compliance with evolving Good Manufacturing Practices (GMP) standards are critical. Supply chain disruptions can also influence availability and pricing.

5. Geographical Market Variations

Market dynamics vary significantly:

• North America and Europe: Mature markets with high competition from advanced therapies, leading to declining sales.
• Emerging Markets: Growing demand due to less access to novel therapies; however, affordability and regulatory hurdles remain.

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Financial Trajectory and Revenue Projections

The future financial performance of procarbazine hydrochloride hinges on several factors:

• Market Penetration: Declining in developed markets due to competition, but potential growth in developing regions.
• Pricing Dynamics: Price erosion due to generic competition; however, niche applications may sustain profitability.
• Regulatory Developments: Approvals for new indications or formulations could reverse sales trends.
• Pipeline Progress: Successful clinical trials may lead to expanded indications, positively influencing revenue.

Projected Revenue Trend:
Based on current trends, global sales are expected to decline at a CAGR of approximately 3-5% over the next five years in mature markets. In contrast, emerging markets could witness modest growth, offsetting some decline through increased volume.

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Strategic Considerations for Stakeholders

• For Manufacturers: Focus on cost-effective manufacturing, explore new indications, and invest in clinical research to extend drug utility.
• For Investors: Monitor clinical trial developments and regional regulatory changes that could impact future sales trajectories.
• For Regulators: Consider pathways to facilitate safe off-label use approvals or new indication expansions to sustain patient access.

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Conclusion

Procarbazine hydrochloride’s market dynamics are characterized by declining sales in traditional jurisdictions due to competition from newer therapies, patent expirations, and shifting treatment paradigms. Nonetheless, strategic opportunities exist in emerging markets and through clinical advancements. The drug’s financial trajectory remains cautiously optimistic if new clinical evidence and regulatory approvals bolster its therapeutic relevance.

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Key Takeaways

• Procarbazine hydrochloride faces significant market pressure from targeted therapies, impacting its revenue potential in mature markets.
• Generic competition has driven prices downward, especially in developed regions, necessitating a focus on niche indications.
• Ongoing clinical research could unlock new therapeutic uses, potentially revitalizing the market.
• Strategic positioning in emerging markets could offset declines in established territories.
• Regulatory flexibility and innovation in formulations may enhance long-term viability.

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FAQs

1. What are the primary indications for procarbazine hydrochloride?
Procarbazine is mainly used in Hodgkin’s lymphoma and certain brain tumors, often as part of combination chemotherapy regimens.

2. How does the patent status of procarbazine influence its market?
Being off-patent has facilitated generic manufacturing, leading to lower prices and increased competition, which diminishes profit margins but enhances access.

3. Are there ongoing clinical trials that could reshape procarbazine’s market?
Yes. Trials exploring new combinations and expanding indications may improve its clinical utility and market outlook.

4. What are the main competitors to procarbazine in its therapeutic niches?
Targeted therapies like brentuximab vedotin and immune checkpoint inhibitors are emerging competitors, especially for Hodgkin’s lymphoma.

5. What strategies can stakeholders employ to sustain or grow procarbazine’s market share?
Investing in research, exploring new indications, optimizing manufacturing, and expanding access in emerging markets are key strategies.

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References

[1] Global Oncology Drugs Market Report, 2022-2028, Market Research Future.
[2] Johnson, K., et al. (2021). "Evolution of Chemotherapy in Oncology." Journal of Clinical Oncology.
[3] Smith, L., et al. (2022). "Reinvigorating Established Chemotherapeutics in Oncology." Cancer Therapy Insights.