SIRTURO Drug Patent Profile

Which patents cover Sirturo, and what generic alternatives are available?

Sirturo is a drug marketed by Janssen Therap and is included in one NDA. There are two patents protecting this drug.

This drug has ninety-seven patent family members in thirty-nine countries.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the bedaquiline fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Sirturo

Sirturo was eligible for patent challenges on December 28, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SIRTURO

International Patents:	97
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	16
Patent Applications:	156
Drug Prices:	Drug price information for SIRTURO
What excipients (inactive ingredients) are in SIRTURO?	SIRTURO excipients list
DailyMed Link:	SIRTURO at DailyMed

See drug prices for SIRTURO

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

NDA:

204384

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.

Recent Clinical Trials for SIRTURO

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

Sponsor	Phase
Tuberculosis Trials Consortium	Phase 2/Phase 3
Centers for Disease Control and Prevention	Phase 2/Phase 3
Beijing Chest Hospital	Phase 4

See all SIRTURO clinical trials

Pharmacology for SIRTURO

Drug Class

Diarylquinoline Antimycobacterial

US Patents and Regulatory Information for SIRTURO

SIRTURO is protected by two US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	204384-002	May 27, 2020		RX	Yes	No			Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes			Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No			Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes			Y	Y

International Patents for SIRTURO

When does loss-of-exclusivity occur for SIRTURO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SIRTURO around the world.

Country	Patent Number	Title	Estimated Expiration
Jordan	2973
Hungary	S1400047
Hong Kong	1214513
Australia	2003262529	QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS
Slovenia	2086940
World Intellectual Property Organization (WIPO)	2008068231
Croatia	P20120639

Supplementary Protection Certificates for SIRTURO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	C20140026 00112	Estonia		PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014
1527050	300684	Netherlands		PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050	C300684	Netherlands		PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050	SPC/GB14/057	United Kingdom		PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTERED: UK EU/1/13/901 20140307
1527050	C 2014 034	Romania		PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A IN-3-IL)-4-(DIMETILAMINO)-2-(NAFTALEN-1-IL)-1-FENILBUTAN-2-OL; NATIONAL AUTHORISATION NUMBER: EU/1/13/901; DATE OF NATIONAL AUTHORISATION: 20140305; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/901; DATE OF FIRST AUTHORISATION IN EEA: 20140305 ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOL
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	50/2014	Austria		PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SIRTURO

Last updated: July 28, 2025

Introduction

SIRTURO (bedaquiline) stands as a groundbreaking therapeutic in the fight against multidrug-resistant tuberculosis (MDR-TB). Approved by the U.S. Food and Drug Administration (FDA) in 2012, it marked a significant advancement in TB treatment, especially for drug-resistant strains. The drug’s unique mechanism, targeting the ATP synthase of Mycobacterium tuberculosis, positions it as an essential component in MDR-TB therapy regimens. Analyzing market dynamics and financial forecasts for SIRTURO requires an understanding of its clinical profile, regulatory landscape, competitive environment, and global health trends impacting TB management.

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Market Overview and Demand Drivers

Global Burden of Tuberculosis and MDR-TB

Tuberculosis remains among the top infectious killers worldwide, with an estimated 10 million cases annually [1]. The rise of multidrug-resistant TB complicates control efforts, threatening to reverse gains made over decades [2]. The World Health Organization (WHO) estimates that MDR-TB accounts for approximately 3.4% of new TB cases and 18% of previously treated cases globally [3], driving significant demand for novel, effective therapies like SIRTURO.

Clinical Advancements and Treatment Paradigms

Historically, MDR-TB treatment relied on second-line drugs with extensive durations, high toxicity, and limited efficacy. The advent of SIRTURO introduced a shorter, more tolerable regimen, improving adherence and outcomes. WHO recommends incorporating bedaquiline into multidrug regimens for MDR-TB, boosting demand, especially in high-burden nations such as India, China, and Russia [4].

Regulatory and Policy Influence

Global health agencies actively promote bedaquiline use. WHO included SIRTURO in its Model List of Essential Medicines in 2018, encouraging widespread adoption [5]. Regulatory approvals in numerous countries have expanded access, influencing sales trajectories.

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Competitive Landscape

Key Players and Alternatives

While SIRTURO remains the flagship in its class, competitors and advancements in TB therapies influence market share:

• Delamanid (Deltyba): Approved by the European Medicines Agency (EMA), with similar indications for MDR-TB.
• Pretomanid: Recently approved in combination with bedaquiline and linezolid (BPaL regimen) for extensively drug-resistant TB (XDR-TB) [6].

Patent and Manufacturing Considerations

Bedaquiline's patent straddle is evolving, with initial exclusivity scheduled to expire around 2027. The entry of generics could significantly reduce prices, expanding access but impacting revenue streams of the original manufacturer, Johnson & Johnson (J&J). J&J’s partnership strategies and patent litigation influence market control.

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Regulatory and Reimbursement Dynamics

Regulatory Landscape

Global approval status varies, with authorities like the FDA, EMA, the Drugs Controller General of India, and others providing approvals based on clinical data submitted. Regulatory pathways emphasizing expedited review, orphan drug status, and priority review have facilitated faster market entry.

Reimbursement Policies and Funding

Funding from national TB programs, Gavi, and the Global Fund influences drug accessibility. In high-burden, resource-limited settings, government procurement significantly impacts sales volume. The integration of SIRTURO into national treatment guidelines correlates with uptake, emphasizing the importance of policy endorsement.

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Financial Trajectory and Revenue Forecasts

Historical Performance

Since its approval, SIRTURO’s sales have steadily increased, driven by expanding indications and geographic coverage. In 2020, Johnson & Johnson reported approximately $216 million in global sales from bedaquiline-based products, reflecting robust demand despite supply chain disruptions caused by COVID-19 [7].

Forecasting Future Revenue Streams

Projections suggest a compound annual growth rate (CAGR) of approximately 6-8% over the next five years, considering:

• Global MDR-TB prevalence: Continued growth in high-burden countries sustains demand.
• Regulatory approvals expansion: New indications, such as XDR-TB, broaden market scope.
• Pricing and reimbursement policies: Introduction of tiered pricing and generic competition may impact margins but could expand volume.
• Patent expiration: Anticipated around 2027; generics could enter markets, pressuring prices.

Impact of Patent Expiry and Generic Competition

The expiration of key patents and approval of biosimilars may lead to a sharp decline in per-unit revenue but could paradoxically increase total volume and aggregate sales, especially in low- and middle-income countries. Strategic licensing and partnership arrangements could mitigate revenue erosion.

Emerging Opportunities: Pediatric and Latent TB

Developments in pediatric formulations and potential applications for latent TB infection could open new revenue streams, contingent on successful clinical trials and regulatory clearances.

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Market Challenges and Risks

• Pricing Pressures: Demand for lower prices in resource-constrained markets could limit profit margins.
• Resistance Concerns: Emergence of bedaquiline-resistant strains poses clinical and commercial risks.
• Regulatory Delays: Approvals in key markets may lag, affecting revenue timelines.
• Supply Chain Disruptions: Global events (e.g., pandemics) impact manufacturing and distribution.

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Strategic Implications for Stakeholders

Manufacturers should prioritize patent management, explore licensing agreements, and invest in novel formulations and combination therapies. Payers and policymakers need to ensure sustainable access through subsidies, drug procurement policies, and inclusion in essential medicines lists. Investors should monitor R&D pipelines, regulatory milestones, and competitive pricing strategies to gauge long-term value.

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Key Takeaways

• Growing Demand: Global MDR-TB prevalence fuels sustained demand for SIRTURO, underpinning a positive market outlook.
• Regulatory Advocacy: Endorsements from WHO and national agencies enhance adoption rates.
• Competitive Pressures: Patent expirations and the entry of generics are imminent threats but also opportunities for market expansion.
• Revenue Prospects: While revenue growth is likely to moderate post-patent expiry, expanded access programs and new indications may offset declines.
• Risk Management: Stakeholders must address resistance development, supply chain issues, and pricing challenges through strategic planning.

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FAQs

1. What factors are driving the global adoption of SIRTURO?
Clinically superior outcomes in MDR-TB, endorsements from WHO and national health authorities, and inclusion in essential medicines lists enhance adoption. Growing MDR-TB prevalence in high-burden countries further sustains demand.

2. How will patent expirations influence SIRTURO’s market share?
Patent expirations around 2027 are expected to enable generic manufacturing, leading to price reductions and increased access, potentially reducing revenue margins but broadening use.

3. Are there any new indications for SIRTURO in development?
Research exploring pediatric formulations, latent TB infection, and combination regimens could expand its clinical utility, pending regulatory approval.

4. What are the primary risks impacting SIRTURO’s financial trajectory?
Resistance development, regulatory delays, supply chain disruptions, and pricing pressures in low-income markets pose ongoing risks.

5. How might emerging competitive therapies affect SIRTURO’s market position?
Innovative drugs like pretomanid and new combination regimens could challenge SIRTURO’s dominance; however, synergistic use and expanding indications may mitigate this threat.

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References

[1] World Health Organization. Global Tuberculosis Report 2022.
[2] Dheda, K., et al. (2017). The global burden of drug-resistant tuberculosis. The Lancet, 390(10091), 2397-2409.
[3] WHO. MDR-TB Data and Statistics.
[4] WHO Consolidated Guidelines on Drug-Resistant Tuberculosis Treatment, 2019.
[5] WHO. Essential Medicines List 2018.
[6] Pretomanid Approved for XDR-TB. (2020). FDA Press Release.
[7] Johnson & Johnson Annual Report 2020.

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This analysis provides a comprehensive view of the market intricacies and financial prospects for SIRTURO, serving as an essential resource for pharmaceutical industry stakeholders, investors, policymakers, and healthcare strategists.