PYRAZINAMIDE - Generic Drug Details

What are the generic sources for pyrazinamide and what is the scope of freedom to operate?

Pyrazinamide is the generic ingredient in one branded drug marketed by Hikma, Macleods Pharms Ltd, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for pyrazinamide. Eight suppliers are listed for this compound.

Summary for PYRAZINAMIDE

US Patents:	0
Tradenames:	1
Applicants:	3
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	125
Patent Applications:	7,074
Drug Prices:	Drug price trends for PYRAZINAMIDE
What excipients (inactive ingredients) are in PYRAZINAMIDE?	PYRAZINAMIDE excipients list
DailyMed Link:	PYRAZINAMIDE at DailyMed

See drug prices for PYRAZINAMIDE

Recent Clinical Trials for PYRAZINAMIDE

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

Sponsor	Phase
All India Institute of Medical Sciences, Jodhpur	Phase 3
Rural Development Trust Hospital	Phase 3
Jawaharlal Institute of Postgraduate Medical Education & Research	Phase 3

See all PYRAZINAMIDE clinical trials

Pharmacology for PYRAZINAMIDE

Drug Class

Antimycobacterial

Medical Subject Heading (MeSH) Categories for PYRAZINAMIDE

Antitubercular Agents

Anatomical Therapeutic Chemical (ATC) Classes for PYRAZINAMIDE

J04AK	Other drugs for treatment of tuberculosis
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for PYRAZINAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319-001	Jun 30, 1992	AB	RX	No	Yes
Novitium Pharma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	080157-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Macleods Pharms Ltd	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	212541-001	Jul 27, 2020	AB	RX	No	No

PYRAZINAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pyrazinamide

Introduction

Pyrazinamide is a crucial antibiotic used in the treatment of tuberculosis (TB), particularly in combination with other drugs like rifampicin, isoniazid, and ethambutol. The market dynamics of pyrazinamide are influenced by several factors, including the prevalence of TB, drug resistance, and global health policies.

Market Size and Growth

The global pyrazinamide market was valued at approximately $143.9 million in 2020 and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period from 2020 to 2027, reaching a projected value of $163.1 million by 2027[1].

In a broader forecast, the market is anticipated to grow at a CAGR of 3 to 5% from 2021 to 2031, with the market size expected to increase significantly over this period[3].

Drivers of Growth

Increasing Prevalence of TB

The rising incidence of TB globally is a significant driver for the pyrazinamide market. For instance, in 2019, the U.S. reported 8,920 new cases of TB, with a rate of 2.7 per 100,000 persons. Similarly, Europe saw 55,337 TB cases in 2017, representing a rate of 10.7 per 100,000 population[1].

Global Health Initiatives

Organizations like the Global Fund play a critical role in funding TB programs, which indirectly supports the demand for pyrazinamide. Despite COVID-19 disruptions, the Global Fund has continued to invest in TB programs, although the pandemic has caused significant setbacks in TB treatment and diagnosis[4].

Restraints and Challenges

Drug Resistance

One of the major restraints on the pyrazinamide market is the increasing incidence of drug-resistant TB. This not only complicates treatment but also reduces the effectiveness of pyrazinamide, leading to higher treatment costs and longer treatment durations. For example, the treatment costs for multi-drug resistant (MDR) TB and extensively drug-resistant (XDR) TB are significantly higher than those for drug-susceptible TB[1].

COVID-19 Pandemic

The COVID-19 pandemic has disrupted the healthcare sector globally, affecting the supply chain of pharmaceutical drugs, including pyrazinamide. Nationwide lockdowns and supply chain issues have slowed the growth of the pyrazinamide market[1].

Regional Analysis

The global pyrazinamide market is segmented into several regions, including North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America

North America is expected to witness significant growth due to the increasing number of TB cases in the U.S. and Canada. In 2019, the U.S. reported 8,916 TB cases, while Canada saw a 2.6% increase in TB cases from 2016 to 2017[1].

Europe

Europe also contributes substantially to the pyrazinamide market, driven by the high number of TB patients. In 2017, Europe reported 55,337 TB cases, which translates to a rate of 10.7 per 100,000 population[1].

Competitive Landscape

The pyrazinamide market is competitive, with several key players operating globally. These include Pure Chemistry Scientific, LGM Pharma, TCI, HBCChem, Alfa Chemistry, Toronto Research Chemicals, Acros Organics, AlliChem, Waterstone Technology, and City Chemical, among others[1][3].

Product Segmentation

The market is segmented based on application (children and adults) and product purity (98%, 99%, and other). This segmentation helps in understanding the specific needs and trends within different demographics and product qualities[3].

Financial Impact of TB Treatment

The financial burden of TB treatment is significant, especially for drug-resistant forms. For instance, the cost of treating drug-sensitive TB in the U.S. was estimated at $49,000 per patient, while MDR-TB and XDR-TB treatments averaged $393,000 and $758,000, respectively[1].

Pharmacokinetic and Pharmacodynamic Considerations

The effectiveness of pyrazinamide, often used in combination with rifampicin, is influenced by pharmacokinetic and pharmacodynamic factors. Studies have shown that the exposure of rifampicin, a cornerstone drug in TB treatment, significantly affects treatment outcomes. Optimal dosing strategies are crucial to ensure efficacy and safety[2].

Global Health Funding and Initiatives

The Global Fund's investment in TB programs is critical for the market. Despite the challenges posed by COVID-19, the Global Fund has deployed significant resources to support TB treatment and diagnosis. Continued funding is essential to combat TB and other diseases effectively[4].

Key Takeaways

• The global pyrazinamide market is driven by the increasing prevalence of TB and supported by global health initiatives.
• Drug resistance and the COVID-19 pandemic are significant restraints on market growth.
• Regional markets, particularly North America and Europe, are expected to show significant growth.
• The competitive landscape includes several key players, and market segmentation is based on application and product purity.
• The financial impact of TB treatment is substantial, especially for drug-resistant forms.

FAQs

1. What is the current market size of the global pyrazinamide market? The global pyrazinamide market was valued at approximately $143.9 million in 2020[1].

2. What is the expected CAGR of the pyrazinamide market from 2020 to 2027? The market is expected to exhibit a CAGR of 4.6% during the forecast period from 2020 to 2027[1].

3. How has the COVID-19 pandemic affected the pyrazinamide market? The pandemic has disrupted the supply chain of pharmaceutical drugs, including pyrazinamide, and has led to a slowdown in the growth of the healthcare sector[1].

4. Which regions are expected to show significant growth in the pyrazinamide market? North America and Europe are expected to witness significant growth due to the increasing number of TB cases in these regions[1].

5. What are the major restraints on the pyrazinamide market? Increasing pyrazinamide drug-resistant TB infections and the disruptions caused by the COVID-19 pandemic are major restraints on the market[1].

Cited Sources:

1. Coherent Market Insights - Pyrazinamide Market Size, Trends And Forecast To 2027
2. Oxford Academic - Pharmacokinetic-Pharmacodynamic Evidence From a Phase 3 Trial
3. Market Research Intellect - Global Pyrazinamide Market Size And Forecast
4. The Global Fund - Investment Case - The Global Fund
5. Dataintelo - Pyrazinamide Market Research Report 2032 - Dataintelo