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Last Updated: December 18, 2025

DOW-ISONIAZID Drug Patent Profile


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When do Dow-isoniazid patents expire, and what generic alternatives are available?

Dow-isoniazid is a drug marketed by Dow Pharm and is included in one NDA.

The generic ingredient in DOW-ISONIAZID is isoniazid. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dow-isoniazid

A generic version of DOW-ISONIAZID was approved as isoniazid by CMP PHARMA INC on November 10th, 1983.

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Summary for DOW-ISONIAZID
Drug patent expirations by year for DOW-ISONIAZID
Recent Clinical Trials for DOW-ISONIAZID

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SponsorPhase
University of MinnesotaPHASE2
Infectious Diseases InstitutePHASE2
National Institute of Mental Health (NIMH)PHASE1

See all DOW-ISONIAZID clinical trials

US Patents and Regulatory Information for DOW-ISONIAZID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dow Pharm DOW-ISONIAZID isoniazid TABLET;ORAL 080330-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DOW-ISONIAZID

Last updated: July 30, 2025


Overview of DOW-ISONIAZID

DOW-ISONIAZID is a formulation of isoniazid, a cornerstone antimicrobial agent used primarily in the treatment and prevention of tuberculosis (TB). Recognized globally for its efficacy against Mycobacterium tuberculosis, isoniazid remains an integral part of first-line antitubercular therapy. The DOW-ISONIAZID variant, developed by Dow Pharmaceuticals, offers a proprietary or optimized formulation aimed at improving bioavailability, reducing side effects, or enhancing compliance.


Market Landscape and Drivers

Global Tuberculosis Burden and Treatment Policies

Despite significant advancements, TB remains a leading infectious killer worldwide, with an estimated 10 million cases and 1.5 million deaths in 2021 alone [1]. The World Health Organization (WHO) underscores the importance of effective chemotherapy, with isoniazid's role in multi-drug regimens being non-negotiable. As TB control programs expand, demand for high-quality, reliable formulations like DOW-ISONIAZID persists.

Patent and Regulatory Environment

The patent landscape heavily influences market dynamics. If DOW-ISONIAZID holds specific patents or formulations, its availability and pricing strategies are tightly controlled. Regulatory pathways for approval vary across regions, affecting market entry speed, especially in emerging markets where TB prevalence is high [2].

Emerging Trends: Resistance and Treatment Innovations

The rise of multi-drug resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) has threatened the efficacy of standard therapies. This drives innovation in formulation science, leading pharmaceutical companies like Dow to develop improved or adjunct therapies. There's also a trend toward shorter treatment regimens, which could influence future demand for optimized formulations like DOW-ISONIAZID.


Market Dynamics: Supply, Demand, and Competition

Supply Chain Considerations

Global production of isoniazid is concentrated among a few major producers, with quality control and affordability being critical factors. Dow’s capacity, manufacturing standards, and regional distribution networks are pivotal in maintaining supply stability, especially amid increasing demand from high-burden countries.

Demand Growth Drivers

  1. Expanding TB Control Programs: Governments and NGOs are scaling up TB detection and treatment initiatives, especially in Africa, Southeast Asia, and Eastern Europe.
  2. Global Health Funding: Initiatives by entities such as the Global Fund increase funding for TB drugs, boosting demand for quality-assured formulations like DOW-ISONIAZID.
  3. Innovative Formulations: Improved formulations that reduce dosing frequency and adverse effects can increase treatment adherence, a key determinant of demand.

Competitive Landscape

Generic formulations of isoniazid exist at lower prices, challenging proprietary products like DOW-ISONIAZID. Nonetheless, DOW’s differentiated formulations, focusing on bioavailability and patient compliance, can command premium pricing and capture niche segments. Multinational pharma firms and regional generic manufacturers constitute the primary competition, with patent status and formulation advantages being decisive factors.


Financial Trajectory and Investment Outlook

Revenue Streams and Profitability

The revenue trajectory of DOW-ISONIAZID hinges on several factors:

  • Market Penetration: Increased adoption in high-burden countries.
  • Pricing Strategies: Premium formulations warrant higher margins but depend on regulatory acceptance.
  • Production Costs: Economies of scale and manufacturing efficiencies influence profitability.

Historical data from similar drugs suggest that proprietary formulations with clear clinical benefits can maintain robust margins, especially if they secure favorable regulatory and reimbursement landscapes.

Growth Projections

Based on current demand drivers, conservative forecasts anticipate a compound annual growth rate (CAGR) of 3-5% in the global TB drug market over the next five years [3]. Should DOW-ISONIAZID leverage formulation advantages and forge strategic partnerships, its market share could grow more rapidly, leading to accelerated revenue streams.

Risks and Challenges

  • Generic Competition: Price erosion from generics may suppress revenue.
  • Regulatory Delays: Prolonged approval processes can defer revenue realization.
  • Resistance Patterns: Emergence of resistance to isoniazid could diminish the drug's efficacy and demand.
  • Funding Fluctuations: Changes in global health funding levels could impact procurement volumes.

Strategic Opportunities and Future Outlook

Innovation remains key. DOW could explore:

  • Combination Therapies: Developing fixed-dose combinations to improve compliance.
  • Delivery Platforms: Novel delivery systems (e.g., long-acting injectables) to reduce dosing frequency.
  • Regional Customization: Tailoring formulations to regional needs, considering variations in resistance and treatment protocols.

Partnerships with governments and global health agencies will be vital for sustained growth, especially in resource-limited settings. Emphasizing clinical efficacy and safety can bolster market positioning amid intense competition.


Key Market Trends

  • Shift Toward Patient-Centric Formulations: Emphasis on reducing pill burden and minimizing side effects.
  • Increased Focus on Resistance Management: Developing formulations capable of overcoming or delaying resistance.
  • Digital and Data-Driven Approaches: Leveraging real-world data to demonstrate pharmaceutical benefits and optimize treatment protocols.
  • Partnerships and Licensing: Collaborations with regional manufacturers to accelerate distribution.

Conclusion

DOW-ISONIAZID occupies a strategic niche in the global TB treatment landscape. Its market dynamics are shaped by global disease burden, resistance patterns, innovation in formulation science, and competitive pressures. Financially, the drug’s trajectory depends on its ability to sustain market share through differentiation and strategic alliances amid an evolving therapeutic environment. Considering the current landscape, the outlook for DOW-ISONIAZID is cautiously optimistic, provided it navigates regulatory, competitive, and epidemiological challenges effectively.


Key Takeaways

  • Global TB burden ensures sustained demand for isoniazid formulations, including DOW-ISONIAZID.
  • Innovation in formulation and compliance-focused delivery can provide competitive advantages.
  • Market growth is moderated by patent landscapes, generic competition, and resistance trends.
  • Strategic partnerships with governments and health organizations are crucial for expanding reach.
  • Financial success hinges on balancing pricing strategies with manufacturing efficiencies and market penetration efforts.

FAQs

1. How does DOW-ISONIAZID differentiate itself from generic isoniazid?
DOW-ISONIAZID’s differentiation likely stems from proprietary formulations that improve bioavailability, reduce side effects, or enhance patient adherence, enabling it to command premium pricing despite generic competition.

2. What impact does rising drug resistance have on DOW-ISONIAZID’s market?
Increasing resistance to isoniazid may limit drug efficacy, prompting demand for new formulations or combination therapies. DOW’s innovation focus can mitigate this impact if it offers solutions overcoming resistance challenges.

3. Are there specific regional markets where DOW-ISONIAZID has a competitive advantage?
Regions with high TB prevalence and robust healthcare infrastructure, such as India, China, and parts of Africa, present significant opportunities, especially if DOW forms partnerships with local health agencies.

4. What are the regulatory challenges faced by DOW-ISONIAZID?
Regulatory approval varies by country, with some markets requiring extensive clinical data. Delays can impact market entry and revenue timelines, especially in highly regulated regions like the US and Europe.

5. What strategic moves could enhance DOW-ISONIAZID’s financial trajectory?
Focusing on combination therapies, reducing manufacturing costs, expanding regional partnerships, and investing in resistance management research are key strategies that can bolster market share and profitability.


References

[1] World Health Organization. Global Tuberculosis Report 2022.
[2] U.S. Food and Drug Administration. Regulatory pathways for tuberculosis drugs.
[3] MarketsandMarkets. Tuberculosis Drugs Market Analysis and Forecast 2022-2027.

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