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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	136
Patent Applications:	7,242
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
Infectious Diseases Institute	PHASE2
University of Minnesota	PHASE2
Huashan Hospital	PHASE3

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
Macleods Pharms Ltd	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	212541-001	Jul 27, 2020	AB	RX	No	No
Novitium Pharma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	080157-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

PYRAZINAMIDE Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What is the Global Market Size and Growth Potential for PYRAZINAMIDE?

Pyrazinamide (PZA) is a fundamental component of first-line anti-tuberculosis (TB) therapy. The global TB market was valued at approximately $0.89 billion in 2022, with PZA representing a significant portion due to ongoing demand for TB treatment regimens. The compound’s role in multi-drug therapy sustains steady growth in markets with high TB prevalence, including India, China, and parts of Africa.

Forecasts suggest the TB drug market will expand at a compounded annual growth rate (CAGR) of 4.2% from 2023 to 2030, driven by increased detection and treatment programs, especially in low- and middle-income countries. The TB pipeline, including novel formulations of PZA and combination therapies, indicates potential for incremental revenue growth, particularly with the development of shorter treatment regimens.

How Do Patent and Regulatory Trends Affect Market Access and Revenue?

Since PZA is an off-patent drug, generic manufacturing dominates, leading to low prices and constrained profit margins. Major global health organizations, such as WHO, promote generic formulations to expand access, limiting exclusivity-driven pricing power.

Regulatory pathways vary by region:

• In the United States, the FDA approves generic PZA formulations through Abbreviated New Drug Applications (ANDAs), under the Drug Price Competition and Patent Term Restoration Act of 1984.
• WHO prequalification facilitates procurement in low-resource settings but does not grant patent rights.
• Patent expiration occurred globally around 2012-2014 for initial formulations.

The absence of patent protections constrains revenue growth for innovator companies. Market entry of generics typically reduces prices by 80-90% within two years of patent expiry.

What Are Key Competitive Factors in the PZA Market?

The market is characterized by:

• High manufacturing capacity for generics. India-based companies (e.g., CIPLA, Lupin) dominate global supply.
• Development of fixed-dose combination pills (FDCs), which include PZA, streamline TB treatment and expand market penetration.
• Growing use of novel formulations, such as sustained-release forms, to improve compliance.

Innovation in delivery methods faces regulatory and cost barriers. Limited pipeline activity exists for new chemical entities of PZA, with focus on reformulations and combination therapies.

What Financial Trends Are Expected for Companies Involved?

Profit margins are thin due to low pricing, but volume remains high because of global TB control programs. Price pressures are intensifying as generic manufacturers increase production capacity.

Major profit centers are:

• Governments and NGOs as bulk purchasers at negotiated prices.
• Large pharmaceutical firms handling manufacturing and distribution.

Increased funding from organizations like the Global Fund supports sustained demand. However, companies investing in R&D for new PZA formulations face limited opportunities for exclusivity, restricting potential revenue beyond initial product lifecycle.

How Does R&D Investment Impact the Future Revenue of PZA?

With minimal R&D directed at PZA itself due to patent expiration and low profit margins, innovation tends toward combination therapies and improved formulations. These enhancements can marginally increase market share rather than generate significant standalone revenue.

Investment in pipeline projects is limited but may include:

• Shorter, more effective treatment regimens.
• Fixed-dose combinational drugs to improve adherence.

Given the low innovation ROI, industry focus shifts toward improving overall TB treatment quality rather than individual drug revenues.

What Are the Emerging Market Opportunities and Risks?

Opportunities:

• Expansion in high-burden regions through procurement agreements.
• Development of improved delivery systems (e.g., inhalable PZA).
• Integration into combination therapies with higher profit margins.

Risks:

• Price erosion driven by generics.
• Regulatory barriers for novel formulations.
• Competition from biosimilars and new anti-TB drugs nearing approval (e.g., pretomanid).

Summary Table: Market Data and Forecasts

Aspect	2022 Data	2023-2030 Forecast	Key Drivers
Market Size (Global)	~$0.89 billion	CAGR 4.2%	TB prevalence, treatment expansion
Patent Status	Expired (2012-2014)	N/A	Generic dominance
Major Players	Cipla, Lupin (India), generic firms	Continued dominance, new formulations	Cost competition, regulatory pathways
Pricing	~$10-$20 per treatment course	Decreases by 80-90% as generics penetrate	Global procurement via WHO, NGOs
R&D Focus	Reformulations, combinations	Marginal for PZA, broader TB drugs	Innovation in delivery systems

Key Takeaways

• PZA is a low-margin, off-patent drug with sustained demand driven by TB treatment protocols.
• The market's growth is primarily volume-driven, with minimal opportunity for revenue enhancement through patent protections.
• Competition from generics constrains pricing, though volume and procurement scale compensate.
• Innovation efforts focus on combination therapies and improved formulations rather than standalone drug performance.
• Companies should prioritize strategic partnerships, scale economies, and pipeline development in TB treatment rather than standalone PZA innovations.

FAQs

1. Why is pyrazinamide considered essential in TB therapy?
It shortens treatment duration and helps prevent drug resistance, making it a backbone of first-line TB regimens.

2. How does patent expiration affect profitability for PZA manufacturers?
It leads to generic market entry, sharply decreasing prices and profit margins.

3. Are there any promising reformulations of PZA in development?
Most innovation is in combination therapies or delivery methods, such as sustained-release formulations, which remain limited.

4. How does the global TB treatment funding impact the PZA market?
Funding supports large-scale procurement, stabilizing demand despite low margins.

5. What future market trends could influence PZA?
Introduction of new anti-TB drugs and shorter treatment regimens could reduce reliance on PZA, potentially decreasing demand.

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References

[1] World Health Organization. (2022). Global Tuberculosis Report.
[2] IQVIA. (2023). Healthcare and Market Insights.
[3] US Food and Drug Administration. (2023). Generic Drug Approvals.
[4] Market Research Future. (2022). TB Drug Market Analysis.
[5] Global Fund. (2023). Procurement and Funding Data.