ISONIAZID - Generic Drug Details

What are the generic drug sources for isoniazid and what is the scope of patent protection?

Isoniazid is the generic ingredient in eleven branded drugs marketed by Sandoz, Roche, Chartwell Rx, Cmp Pharma Inc, Lannett, Dow Pharm, Medpointe Pharm Hlc, Novartis, Barr, Duramed Pharms Barr, Epic Pharma Llc, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Omnivium Pharms, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, Whiteworth Town Plsn, Chartwell Molecular, Bristol Myers Squibb, Everylife, and Sanofi Aventis Us, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for isoniazid. Sixteen suppliers are listed for this compound.

Summary for ISONIAZID

US Patents:	0
Tradenames:	11
Applicants:	32
NDAs:	47
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	226
Patent Applications:	6,733
Drug Prices:	Drug price trends for ISONIAZID
What excipients (inactive ingredients) are in ISONIAZID?	ISONIAZID excipients list
DailyMed Link:	ISONIAZID at DailyMed

See drug prices for ISONIAZID

Recent Clinical Trials for ISONIAZID

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

Sponsor	Phase
Freundeskreis Für Internationale Tuberkulosehilfe e.V	Phase 3
Christian Medical College, Vellore, India	Phase 3
Indian Council of Medical Research	Phase 3

See all ISONIAZID clinical trials

Pharmacology for ISONIAZID

Drug Class

Antimycobacterial

Medical Subject Heading (MeSH) Categories for ISONIAZID

Antitubercular Agents

Fatty Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ISONIAZID

J04AC	Hydrazides
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ISONIAZID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duramed Pharms Barr	ISONIAZID	isoniazid	TABLET;ORAL	088231-001	Mar 17, 1983		DISCN	No	No
Barr	ISONIAZID	isoniazid	TABLET;ORAL	080937-002	Approved Prior to Jan 1, 1982	AA	RX	No	Yes
Roche	RIMIFON	isoniazid	INJECTABLE;INJECTION	008420-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma Intl Pharms	ISONIAZID	isoniazid	TABLET;ORAL	087425-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Barr	ISONIAZID	isoniazid	TABLET;ORAL	080936-001	Approved Prior to Jan 1, 1982	AA	RX	No	Yes
Thepharmanetwork Llc	ISONIAZID	isoniazid	TABLET;ORAL	202610-001	Oct 29, 2014	AA	RX	No	No

ISONIAZID Market Analysis and Financial Projection Experimental

Isoniazid Market Dynamics and Financial Trajectory

Market Overview

Isoniazid, a crucial antibiotic in the treatment of tuberculosis (TB), is experiencing significant growth in the global market. Here’s a detailed look at the market dynamics and financial trajectory of isoniazid.

Market Size and Growth

The isoniazid market was valued at USD 0.792 billion in 2023 and is projected to reach USD 1.13 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.9% from 2024 to 2031[4].

Market Segmentation

The isoniazid market is segmented based on several key factors:

By Type

• The market is divided into two main types: above 98% isoniazid and below 98% isoniazid. This segmentation is critical as the purity of isoniazid can affect its efficacy and safety[1].

By End Users/Applications

• The market is categorized into hospitals, clinics, and other healthcare facilities. Isoniazid is widely used in these settings for treating both latent and active tuberculosis infections[1].

By Product Form

• Isoniazid is available in various forms such as tablets, syrups, and injectable solutions. These different formulations cater to different patient needs and preferences[4].

Regional Analysis

The isoniazid market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of the market.

• Asia-Pacific: This region is expected to be a significant contributor to the growth of the isoniazid market due to the high prevalence of TB and improving healthcare infrastructure.
• Middle East and Africa: These regions also show substantial growth potential due to the ongoing efforts to control TB and the increasing demand for effective treatments[1].

Drivers and Opportunities

Several factors are driving the growth of the isoniazid market:

Increasing Prevalence of Tuberculosis

• TB remains a major global health concern, particularly in underdeveloped nations. The ongoing need for effective treatments drives the demand for isoniazid[4].

Government Initiatives and International Support

• Government-funded TB control programs and partnerships between pharmaceutical companies and healthcare organizations are crucial in promoting the use of isoniazid[4].

Technological Advancements

• Improvements in pharmaceutical formulations and diagnostic tools enhance treatment efficacy and patient compliance, further boosting the market[4].

Economic Viability of Treatment Regimens

• Shorter treatment regimens, such as daily isoniazid/rifapentine for one month or weekly isoniazid/rifapentine for three months, have been shown to be more cost-effective and improve patient adherence compared to traditional nine-month isoniazid monotherapy[2].

Challenges and Restraints

Despite the growth, the isoniazid market faces several challenges:

Adherence Issues

• Nearly half of patients started on isoniazid fail to complete the full treatment course, which can lead to treatment failure and the development of drug-resistant TB[2].

Drug Resistance

• The rise of multidrug-resistant TB poses a significant threat to the effectiveness of isoniazid and other first-line TB treatments[3].

Competitive Landscape

The isoniazid market is competitive, with several key players:

• AMSAI CHEM
• Resonance Specialties
• Calyx Pharma and Chem
• Camus Pharma
• Titan Pharma (India)
• Taizhou Tianrui Pharmaceutical
• Zhejiang Second Pharma

These companies are focusing on organic and inorganic growth strategies such as product launches, partnerships, and acquisitions to expand their market share[1].

Financial Projections

The financial trajectory of the isoniazid market is promising:

• Market Size: Expected to grow from USD 0.792 billion in 2023 to USD 1.13 billion by 2031.
• CAGR: Projected at 5.9% from 2024 to 2031.
• Regional Growth: Significant growth anticipated in APAC and MEA regions due to high TB prevalence and improving healthcare infrastructure[4].

PEST and SWOT Analysis

The market is influenced by various political, economic, social, and technological factors:

• Political Factors: Government policies and funding for TB control programs significantly impact the market.
• Economic Factors: Cost-effectiveness of treatment regimens and overall healthcare expenditure influence market dynamics.
• Social Factors: Public awareness and healthcare access play crucial roles.
• Technological Factors: Advances in drug delivery methods and diagnostic tools enhance treatment outcomes[1].

Key Takeaways

• The isoniazid market is growing steadily due to the ongoing global burden of TB.
• Technological advancements and government initiatives are key drivers.
• Shorter treatment regimens are more cost-effective and improve patient adherence.
• The market faces challenges such as adherence issues and drug resistance.
• Key players are adopting various growth strategies to expand their market share.

FAQs

1. What is the projected CAGR of the isoniazid market from 2024 to 2031?

The isoniazid market is expected to grow at a CAGR of 5.9% from 2024 to 2031[4].

2. Which regions are expected to contribute significantly to the growth of the isoniazid market?

Asia-Pacific and Middle East & Africa regions are anticipated to be significant contributors due to the high prevalence of TB and improving healthcare infrastructure[1].

3. What are the main types of isoniazid segmented in the market?

The market is segmented into above 98% isoniazid and below 98% isoniazid based on purity[1].

4. How do shorter treatment regimens impact the isoniazid market?

Shorter regimens, such as daily isoniazid/rifapentine for one month or weekly isoniazid/rifapentine for three months, are more cost-effective and improve patient adherence compared to traditional nine-month isoniazid monotherapy[2].

5. Which companies are key players in the isoniazid market?

Key players include AMSAL CHEM, Resonance Specialties, Calyx Pharma and Chem, Camus Pharma, Titan Pharma (India), Taizhou Tianrui Pharmaceutical, and Zhejiang Second Pharma[1].

Cited Sources:

1. The Insight Partners - Isoniazid Market Dynamics 2021-2031[1]
2. PLOS ONE - Potential Economic Viability of Two Proposed Rifapentine-Based Regimens for the Treatment of Latent Tuberculosis Infection[2]
3. Stop TB Partnership - Global Drug Facility Announces Historic Price Reductions for Bedaquiline[3]
4. Market Research Intellect - Global Isoniazid Market Size and Forecast[4]