Pretomanid - Generic Drug Details

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

Pretomanid is the generic ingredient in one branded drug marketed by Mylan Ireland Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for pretomanid

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	25
Patent Applications:	504
Drug Prices:	Drug price trends for pretomanid
What excipients (inactive ingredients) are in pretomanid?	pretomanid excipients list
DailyMed Link:	pretomanid at DailyMed

See drug prices for pretomanid

Recent Clinical Trials for pretomanid

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

Sponsor	Phase
University of California, San Francisco	PHASE2
Johns Hopkins University	PHASE2
Otsuka Pharmaceutical Development & Commercialization, Inc.	PHASE3

See all pretomanid clinical trials

Pharmacology for pretomanid

Drug Class	Antimycobacterial
Mechanism of Action	Organic Anion Transporter 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for pretomanid

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 pretomanid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862-001	Aug 14, 2019		RX	Yes	Yes
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862-001	Aug 14, 2019		RX	Yes	Yes
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862-001	Aug 14, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for pretomanid

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan IRE Healthcare Limited	Dovprela (previously Pretomanid FGK)	pretomanid	EMEA/H/C/005167Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	yes	2020-07-31

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Pretomanid

Last updated: July 28, 2025

Introduction

Pretomanid is an anti-tuberculosis (TB) medication developed by the global pharmaceutical firm, TB Alliance. Approved by the U.S. Food and Drug Administration (FDA) in August 2019, it is primarily used as part of combination therapy to treat multidrug-resistant tuberculosis (MDR-TB). As a novel nitroimidazole compound, pretomanid marks significant progress in TB treatment, particularly for drug-resistant strains posing a mounting global health challenge. Understanding its market dynamics and financial trajectory is critical for stakeholders, including pharmaceutical companies, investors, healthcare policymakers, and global health organizations.

Market Landscape and Epidemiological Drivers

Global Tuberculosis Burden and Resistance Trends

According to the World Health Organization (WHO), in 2021, approximately 10 million individuals contracted TB worldwide, with 1.5 million fatalities, making it among the top infectious disease killers globally [1]. Notably, over 177,000 cases involve MDR or rifampicin-resistant TB (RR-TB), challenging medical management due to limited efficacious therapies.

The rise of drug-resistant strains drives unmet medical needs. MDR-TB, defined by resistance to at least isoniazid and rifampicin, complicates treatment, increasing therapy duration, toxicity, and costs. Pretomanid, incorporated into the BPaL regimen (bedaquiline, pretomanid, and linezolid), offers an oral, shorter, and more tolerable treatment for such cases [2].

Regulatory Approvals and Indications

Since its approval, pretomanid's primary indication is as part of the BPaL regimen for XDR-TB and treatment-intolerant or non-responsive MDR-TB. The U.S. FDA’s accelerated approval has catalyzed its global recognition, with regulators in Europe, South Africa, and other regions evaluating comparable indications.

Market Segments and Key Stakeholders

Major stakeholders include:

• Pharmaceutical Developers: TB Alliance, marketed as the innovator.
• Global Health Agencies: WHO, Global Fund, CDC.
• National Governments: Particularly those with high MDR-TB burdens, e.g., India, China, Russia.
• Hospitals and Clinics: Implementing TB treatment protocols.
• Investors and Commercial Partners: Focused on innovation and access.

Market Dynamics

Factors Driving Market Growth

• Rising MDR/XDR-TB Cases: The increasing prevalence directly expedites demand for effective therapies like pretomanid.
• Shift Toward Oral Regimens: The move away from injectable-based therapies improves adherence, leading to a preference for oral drugs like pretomanid.
• Regulatory Approvals and Support: Accelerated approval pathways and supportive policies promote market entry.
• Global TB Control Initiatives: Programs by WHO and the Global Fund incentivize adoption of innovative regimens to meet disease reduction targets.

Challenges Limiting Market Expansion

• Price and Accessibility: Cost constraints hinder adoption in low-income regions, where TB burden is highest.
• Patent and Market Exclusivity: Patent protections could influence pricing strategies, impacting affordability.
• Limited Awareness and Infrastructure: Healthcare systems in endemic regions may lack capacity to implement advanced regimens.
• Resistance Development: Potential emergence of resistance to pretomanid necessitates continuous surveillance.

Competitive Landscape

Pretomanid competes with other novel agents such as bedaquiline, delamanid, and linezolid-containing regimens. While pretomanid’s unique mechanism offers advantages, generics and alternative therapies influence market presence.

Financial Trajectory

Revenue Generation and Market Adoption

Post-approval, pretomanid's commercial success hinges on:

• Pricing Strategies: Balancing affordability and incentivizing R&D recoveries.
• Distribution Networks: Ensuring availability in high-burden countries.
• Partnerships: Collaborations with governments and NGOs amplify adoption.
• Integration into Treatment Protocols: Adoption by WHO guidelines catalyzes broader use.

In its initial years, sales revenue remains modest but poised for significant growth as global adoption accelerates. The push for combination regimens shortens treatment durations, improving patient outcomes and reducing costs, indirectly expanding the drug's market.

Forecasts and Investment Outlook

Analysts project that the global drug market for MDR-TB treatments will reach a compound annual growth rate (CAGR) of approximately 10-12% over the next five years (2023–2028), driven by increased access and novel regimen adoption [3].

The public-private partnership model, exemplified by TB Alliance, reduces R&D risk, facilitating market penetration. With increasing global focus on TB elimination targets for 2030, investments in pretomanid and related therapies are expected to rise.

Pricing and Cost-Effectiveness Considerations

Cost considerations significantly influence market penetration in low- and middle-income countries. While proprietary pricing may limit access, generic licensing agreements and tiered pricing strategies are essential to expand reach, especially where government procurement dominates.

Potential for Future Indications and Revenue Streams

Further research into pretomanid's efficacy in other resistant bacterial infections could diversify revenue streams. Additionally, new formulations or combinations may unlock additional market segments.

Regulatory and Policy Impacts

The regulatory environment profoundly influences pretomanid’s financial trajectory. WHO endorsement can drive global procurement. Moreover, national policies favoring innovative TB regimens post-pandemic are likely to facilitate broader market penetration.

Conclusion

Pretomanid’s market dynamics embody a convergence of pressing global health needs, technological innovation, and regulatory evolution. While initial revenues are moderate, prospects for growth are promising, especially under ambitious TB eradication strategies. Achieving substantial market penetration requires addressing affordability, infrastructure limitations, and awareness, particularly in endemic regions. Strategic collaborations and adaptive pricing models are pivotal in translating clinical success into robust commercial outcomes.

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Key Takeaways

• Rising MDR-TB prevalence sustains demand for pretomanid, especially in combination regimens.
• Regulatory approvals have accelerated market access, with potential for further international endorsement.
• Market growth is contingent on affordability strategies, infrastructure development, and policy support.
• Revenue projections foresee a CAGR of 10-12%, driven by adoption of shorter, oral regimens.
• Strategic partnerships and licensing can expand access and optimize financial returns.

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FAQs

1. What makes pretomanid a significant advancement in TB treatment?
   Pretomanid’s novel mechanism and role in short, all-oral regimens provide an effective option against resistant TB strains, reducing treatment duration and improving patient compliance.

2. How does pretomanid compare to other anti-TB agents like bedaquiline?
   Pretomanid complements agents like bedaquiline but offers distinct mechanisms and is often used in combination therapies designed for resistant strains, with a focus on oral administration.

3. What are the main hurdles for pretomanid’s global market expansion?
   Key challenges include high costs, limited infrastructure in endemic regions, patent protections, and lack of awareness among healthcare providers.

4. What is the potential for pretomanid’s use beyond MDR and XDR-TB?
   Current research explores its efficacy against other resistant bacterial infections, though regulatory approval in these areas remains pending.

5. How do public health initiatives influence pretomanid's market prospects?
   WHO and global health agencies’ endorsements and procurement policies significantly enhance access, making pretomanid a critical component in TB control strategies.

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References

1. WHO. Global Tuberculosis Report 2022. World Health Organization, 2022.
2. Bissa M, et al. "Pretomanid in the Treatment of Drug-Resistant Tuberculosis." Expert Review of Anti-Infective Therapy, 2021.
3. Market Research Future. "Global TB Treatment Market Forecast (2023-2028)." 2022.