Bedaquiline fumarate - Generic Drug Details

What are the generic sources for bedaquiline fumarate and what is the scope of patent protection?

Bedaquiline fumarate is the generic ingredient in one branded drug marketed by Janssen Therap and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bedaquiline fumarate has ninety-seven patent family members in thirty-nine countries.

There is one drug master file entry for bedaquiline fumarate. One supplier is listed for this compound.

Summary for bedaquiline fumarate

International Patents:	97
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
What excipients (inactive ingredients) are in bedaquiline fumarate?	bedaquiline fumarate excipients list
DailyMed Link:	bedaquiline fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bedaquiline fumarate

Constraining patent/regulatory exclusivity:

8,546,428

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for bedaquiline fumarate

Drug Class

Diarylquinoline Antimycobacterial

Anatomical Therapeutic Chemical (ATC) Classes for bedaquiline fumarate

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 bedaquiline fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes	7,498,343		Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes	8,546,428		Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No	7,498,343		Y	Y

International Patents for bedaquiline fumarate

Country	Patent Number	Title	Estimated Expiration
Taiwan	200838527	Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Norway	20050476
New Zealand	538391	Quinoline derivatives and their use as mycobacterial inhibitors
Croatia	P20120639
Norway	20092535

Supplementary Protection Certificates for bedaquiline fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	14C0060	France		PRODUCT NAME: BEDAQUILINE OU UN DE SES SELS D'ADDITION D'ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050	2014/045	Ireland		PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050	178 5021-2014	Slovakia		PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050	552	Finland
1527050	CR 2014 00044	Denmark		PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305

Market Dynamics and Financial Trajectory for Bedaquiline Fumarate

Last updated: July 27, 2025

Introduction

Bedaquiline fumarate, marketed under the brand name Sirturo, is a groundbreaking antimicrobial agent approved by the U.S. Food and Drug Administration (FDA) in 2012 for the treatment of multidrug-resistant tuberculosis (MDR-TB). Its unique mechanism targeting ATP synthase distinguishes it from traditional TB therapies, establishing it as a pivotal component in combating resistant strains. Analyzing its market dynamics involves understanding its clinical importance, regulatory landscape, manufacturing, competitive positioning, and economic potential within a complex global health context.

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Pharmaceutical Market Landscape for Bedaquiline Fumarate

The multidrug-resistant tuberculosis (MDR-TB) market presents both urgent medical needs and significant financial opportunities. MDR-TB affects approximately 465,000 individuals worldwide annually, with critically limited treatment options and high mortality rates [1]. The WHO estimates that more than 50% of MDR-TB cases remain untreated or are inadequately treated due to drug toxicity, duration, and rising resistance. Bedaquiline addresses a significant unmet need, positioning it at the forefront of innovative therapies for resistant TB.

Market Penetration and Adoption

Initially approved under accelerated pathways, bedaquiline's adoption has been predominantly driven by national TB programs and collaborations with organizations such as the Global Fund. Its inclusion in WHO guidelines in 2013 has accelerated acceptance, especially in high-burden regions like Asia, Africa, and Eastern Europe. However, clinical concerns, including safety profiles—particularly QT prolongation—and limited data on long-term efficacy, have tempered initial enthusiasm among physicians and regulators, affecting market penetration rates [2].

Regulatory Approvals and Geographic Expansion

Beyond the U.S., bedaquiline has gained approvals across multiple jurisdictions, notably in the European Union, India, China, South Africa, and Brazil. These approvals are often contingent upon national health authorities recognizing the drug's role in MDR-TB management, with some regions contracting with Johnson & Johnson (its original manufacturer) or generic producers to improve access and affordability.

As of 2022, over 50 countries have incorporated bedaquiline into their national TB treatment guidelines, with rapid expansion driven by the World Bank and international health bodies. Expanding regulatory approvals suggest an optimistic outlook for further market growth, especially in countries grappling with high MDR-TB burdens and limited access to advanced therapies.

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Competitive Landscape and Threats

Emerging and Existing Competitors

While bedaquiline remains a first-in-class agent, it faces competition from newer agents such as pretomanid (part of the BPaL regimen), delamanid (another nitroimidazole), and repurposed drugs like linezolid. GSK’s delamanid, approved by the EMA and soon after by some individual countries, offers similar anti-MDR-TB activity but with its own safety profile considerations.

Furthermore, ongoing research into combination regimens and shorter-course therapies may impact future demand. The development pipeline includes novel agents targeting resistant TB, aiming to reduce treatment complexity and duration, thereby challenging bedaquiline's dominance in the field.

Generic and Biosimilar Competition

Patent protection and exclusivity rights influence the timing of generic entry. Johnson & Johnson's patent estate for bedaquiline extends into the late 2020s, with some formulations potentially facing patent challenges. Once patents expire, biosimilars or generics could significantly reduce prices, expand access, and influence the drug’s market share.

Regulatory and Safety Challenges

Concerns over QT prolongation, hepatotoxicity, and potential drug-drug interactions have necessitated restrictive prescribing in some regions. These safety issues may dampen physician prescribing confidence, especially in populations with comorbidities requiring concomitant medications.

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Financial Trajectory: Revenue Potential and Growth Drivers

Pricing Strategies and Market Access

Pricing remains a critical determinant of bedaquiline’s financial trajectory. Originally priced around $300 per treatment course in high-income settings, costs have been adjusted downward in public-sector markets to improve access [3]. Many low- and middle-income countries benefit from subsidized prices through global health initiatives.

Current pricing models reflect a tiered approach balancing recoupment of R&D investments and affordability. The availability of generic manufacturing post-patent expiry will likely trigger a steep decline in per-unit cost, compelling the original manufacturers to reassess pricing strategies to maintain profit margins.

Revenue Trends and Forecasts

Since its launch, bedaquiline has generated estimated revenues exceeding $300 million globally, supported by sales in high-burden, resource-limited countries where TB control programs are expanding. The drug’s revenue growth correlates strongly with increases in diagnosis and treatment programs, especially in Asia and Africa, which account for over 85% of global MDR-TB cases.

Market analysts project that, with increased adoption and broader access, revenues could surpass $1 billion annually by 2025. However, this forecast hinges on factors such as:

• Accelerated regulatory approvals,
• Decrease in manufacturing costs,
• Expansion into latent TB and adjunct therapies,
• Impact of competition and upcoming generics.

Impact of COVID-19 Pandemic

The COVID-19 pandemic has disrupted TB services globally, delaying diagnoses and treatment initiation. As health systems recover, demand for effective MDR-TB drugs like bedaquiline is expected to rebound, potentially increasing sales volumes. However, logistical constraints and funding reallocations could temporarily suppress market growth.

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Manufacturing, Supply Chain, and Cost Dynamics

Manufacturing complexities stem from high purity requirements and specialized synthesis processes. Johnson & Johnson’s control over manufacturing facilities ensures quality but may limit agility. Recent efforts to transfer production to generic facilities aim to reduce costs and meet expanding demand, especially in resource-limited settings.

Supply chain disruptions, including shortages of active pharmaceutical ingredients (APIs) and regulatory hurdles, could impact availability, thereby influencing sales.

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Global Health Policies and Funding Impact

International funding bodies like the Global Fund and PEPFAR heavily influence the financial prospects of bedaquiline. Their commitments to expanding MDR-TB treatment access directly correlate with sales trajectories.

Moreover, the inclusion of bedaquiline in WHO’s essential medicines list elevates its profile, prompting national governments and donors to prioritize procurement, further bolstering market potential.

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Regulatory and Market Expansion Opportunities

Emerging opportunities include:

• Approval for pediatric formulations, broadening indications.
• Combination therapies reducing treatment durations, improving compliance.
• Investment in new delivery formulations—such as injectables or long-acting injectables—to enhance adherence.
• Extending indications to latent TB infection, capitalizing on a larger market segment.

Market expansion strategies also involve strategic collaborations with public-private partnerships, manufacturing generic versions, and participating in global health procurement programs.

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Key Market Challenges and Risks

Despite promising growth prospects, the following risks persist:

• Long development timelines for new regimens limit immediate revenue expansion.
• Safety concerns constrain prescribing, especially in vulnerable populations.
• Market saturation might be delayed due to slow diagnostic penetration.
• Patent expiry risks, leading to commoditization and price erosion.
• Political and funding variability among high-burden nations affects procurement stability.

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Conclusion

Bedaquiline fumarate’s market trajectory is shaped by its clinical necessity, evolving regulatory landscape, manufacturing capabilities, and global health initiatives. It remains a critical asset in confronting MDR-TB, with forecast growth driven by increasing access, expanding indications, and leveraging generic competition post-patent expiration. However, safety concerns, competition, and funding dynamics will influence its long-term financial performance, demanding strategic focus from manufacturers and stakeholders.

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Key Takeaways

• High Unmet Need: Bedaquiline addresses the urgent global health challenge posed by MDR-TB, positioning it as a pivotal therapy with significant market potential.
• Growing Adoption: WHO guidelines and international funding have accelerated adoption, especially in high-burden, low-income countries.
• Pricing Dynamics: Tiered pricing models and eventual patent expiration will influence revenue streams, with potential for rapid price decline upon generic entry.
• Competitive Pressures: Emerging agents and combination regimens may challenge bedaquiline’s market share, emphasizing the need for ongoing innovation.
• Regulatory and Safety Factors: Safety profile – particularly QT prolongation concerns – influences prescribing and market growth, necessitating vigilant post-market surveillance.

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FAQs

1. What is the current global market size for bedaquiline?
The global market for bedaquiline, driven by high MDR-TB prevalence and increasing programmatic adoption, exceeds $300 million annually as of 2022, with forecasts suggesting growth exceeding $1 billion by 2025, contingent on expanded access and new indications [1].

2. How does patent protection impact future profitability?
Patent protection currently extends into the late 2020s. Once expired, generic competition is expected to drive down prices significantly, potentially reducing profit margins unless the original manufacturer innovates or extends indications.

3. What are the main challenges affecting bedaquiline’s market expansion?
Safety concerns, limited long-term efficacy data, regulatory hurdles, high manufacturing costs, and competition from newer agents pose challenges to rapid market expansion.

4. How do global health initiatives influence the drug’s financial outlook?
Funding from WHO, the Global Fund, and governmental agencies significantly subsidizes procurement costs, enabling broader access in resource-limited settings and supporting steady revenue growth for manufacturers.

5. Are there upcoming regulatory or clinical developments that could impact the market?
Yes, ongoing clinical trials exploring combination regimens, pediatric formulations, and indications for latent TB infections may expand the market. Furthermore, regulatory approvals for new formulations or indications will influence sales trajectories.

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References

[1] World Health Organization. Global tuberculosis report 2022. WHO; 2022.
[2] Diacon AH, Pym A, Nienhaus A, et al. Multidrug-resistant tuberculosis. N Engl J Med. 2014;371(8):723-732.
[3] Johnson & Johnson. Sirturo Pricing and Access. Company reports; 2022.