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:	88
Patent Applications:	7,158
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
Hospital Civil de Guadalajara	Phase 4
University of Guadalajara	Phase 4
Merck Sharp & Dohme Corp.	Phase 2

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

PROCARBAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Procarbazine Hydrochloride

Introduction to Procarbazine Hydrochloride

Procarbazine hydrochloride is an orally active alkylating agent with significant anticancer activity, primarily used in the treatment of Hodgkin's disease. Here, we will delve into the market dynamics and financial trajectory of this crucial chemotherapeutic agent.

Market Size and Forecast

The global market for procarbazine is projected to experience steady growth. As of 2023, the market was estimated to be worth US$ 2190 million. By 2030, it is forecasted to reach a readjusted size of US$ 2821.7 million, with a Compound Annual Growth Rate (CAGR) of 3.7% during the forecast period from 2024 to 2030[1].

Key Market Players

The procarbazine market is dominated by several major pharmaceutical companies. These include F. Hoffmann-La Roche Ltd., Pfizer Inc., Novartis AG, Leadiant Biosciences, Chemspec-API, ChemPacific, Macklin Inc., Alliance Pharmaceuticals, Matulane, and Fagron. These companies play a significant role in the production, distribution, and research and development of procarbazine hydrochloride[1].

Segmentation by Type and Application

The market for procarbazine hydrochloride is segmented based on the type of the drug and its applications. The types include 50 mg, 25 mg, and other formulations. The primary applications are in hospitals, clinics, and other healthcare settings. Understanding these segments is crucial for targeting specific markets and patient needs[1].

Geographical Distribution

The market for procarbazine hydrochloride is spread across various regions, with different countries having varying demand and supply dynamics. The report covers market forecasts and competitive landscapes by region, which helps in identifying potential growth areas and market penetration strategies[1].

Carcinogenicity and Safety Concerns

Procarbazine hydrochloride is known to have carcinogenic properties, as it has been shown to cause tumors in experimental animals. It is reasonably anticipated to be a human carcinogen based on sufficient evidence from animal studies. This aspect is critical for regulatory approvals and patient safety considerations[2].

Usage and Dosage

Procarbazine hydrochloride is used in combination with other antineoplastic agents for the treatment of Hodgkin's disease. The recommended dose for adults in the MOPP regimen is 100 mg/m² for 10 to 14 days. Understanding the dosage and treatment protocols is essential for both clinical practice and market analysis[2].

Production and Supply Chain

The production of procarbazine hydrochloride involves several manufacturers and suppliers. In the United States, for instance, there are identified manufacturers and suppliers who contribute to the global supply. The production process, import, and export dynamics are vital for ensuring a stable supply chain and meeting market demands[2].

Financial Performance and Revenue Forecast

The financial performance of the procarbazine hydrochloride market is closely tied to its revenue forecast. With a projected market size of US$ 2821.7 million by 2030, the revenue is expected to grow steadily. This growth is driven by increasing demand for effective chemotherapeutic agents, advancements in treatment protocols, and the expanding patient population[1].

Growth Factors and Trends

Several factors contribute to the growth of the procarbazine hydrochloride market. These include:

• Increasing Incidence of Hodgkin's Disease: The rising number of cases of Hodgkin's disease globally drives the demand for effective treatments.
• Advancements in Chemotherapy: Continuous research and development in chemotherapy regimens enhance the efficacy and safety of procarbazine hydrochloride.
• Regulatory Approvals: Favorable regulatory environments and approvals for new formulations and indications support market growth.
• Competitive Landscape: The presence of multiple key players fosters competition, leading to innovations and better market penetration[1].

Challenges and Limitations

Despite the growth potential, the market faces several challenges:

• Carcinogenic Risks: The known carcinogenic properties of procarbazine hydrochloride necessitate careful patient monitoring and risk management.
• Side Effects: The drug can cause significant side effects, which may impact patient compliance and overall market acceptance.
• Competition from Alternative Treatments: The emergence of new chemotherapeutic agents and treatment modalities can pose a threat to the market share of procarbazine hydrochloride[2].

Conclusion

The market for procarbazine hydrochloride is poised for steady growth, driven by increasing demand for effective treatments for Hodgkin's disease and other cancers. With a projected market size of US$ 2821.7 million by 2030, the financial trajectory looks promising. However, it is crucial to address the challenges associated with the drug's carcinogenic properties and side effects to ensure sustained market growth.

Key Takeaways

• The global market for procarbazine hydrochloride is expected to reach US$ 2821.7 million by 2030.
• The market is dominated by key players such as F. Hoffmann-La Roche Ltd., Pfizer Inc., and Novartis AG.
• The drug is primarily used in the treatment of Hodgkin's disease.
• Carcinogenic risks and side effects are significant challenges.
• Advancements in chemotherapy and favorable regulatory environments support market growth.

Frequently Asked Questions (FAQs)

Q: What is the projected market size for procarbazine hydrochloride by 2030? A: The projected market size for procarbazine hydrochloride by 2030 is US$ 2821.7 million[1].

Q: Who are the main players in the procarbazine hydrochloride market? A: The main players include F. Hoffmann-La Roche Ltd., Pfizer Inc., Novartis AG, Leadiant Biosciences, and others[1].

Q: What are the primary applications of procarbazine hydrochloride? A: The primary applications are in hospitals, clinics, and other healthcare settings for the treatment of Hodgkin's disease[1].

Q: What are the known risks associated with procarbazine hydrochloride? A: Procarbazine hydrochloride is reasonably anticipated to be a human carcinogen and can cause significant side effects[2].

Q: How is procarbazine hydrochloride typically administered? A: It is administered orally, often in combination with other antineoplastic agents, with a recommended dose of 100 mg/m² for 10 to 14 days in the MOPP regimen[2].

Cited Sources

1. Valuates Reports: "Procarbazine - Market Size" - [https://reports.valuates.com/market-reports/QYRE-Auto-34D13889/global-procarbazine][1]
2. National Toxicology Program: "RoC Profile: Procarbazine and Its Hydrochloride" - [https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/procarbazine.pdf][2]
3. MedChemExpress: "Procarbazine Hydrochloride" - [https://www.medchemexpress.com/Procarbazine-Hydrochloride.html][4]
4. National Cancer Institute: "Procarbazine Hydrochloride" - [https://www.cancer.gov/about-cancer/treatment/drugs/procarbazinehydrochloride][5]