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

Constraining patent/regulatory exclusivity:

8,546,428

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.

This potential generic entry date is based on patent 8,546,428.

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	8,546,428		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	204384-001	Dec 28, 2012		RX	Yes	Yes
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No	7,498,343		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
Luxembourg	92520
Eurasian Patent Organization	200500257	ПРОИЗВОДНЫЕ ХИНОЛИНА И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ МИКОБАКТЕРИАЛЬНЫХ ИНГИБИТОРОВ
New Zealand	576485	FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Portugal	1527050
Mexico	2009005909	SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETI L]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL. (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMIN O)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEE THANOL.)

Supplementary Protection Certificates for SIRTURO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	132014902288493	Italy		PRODUCT NAME: BEDAQUILINA O UN SUO SALE DI ADDIZIONE DI ACIDO O BASE FARMACEUTICAMENTE ACCETTABILE INCLUSO BEDAQUILINA FUMARATO(SIRTURO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/901, 20140305
1527050	92520	Luxembourg		PRODUCT NAME: BEDAQUILINE, OU SON SEL D ADDITION D ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE. FIRST REGISTRATION: 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	50/2014	Austria		PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
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

Market Dynamics and Financial Trajectory for SIRTURO (bedaquiline)

Last updated: February 19, 2026

What is the current market landscape for SIRTURO?

SIRTURO (bedaquiline) is an anti-tuberculosis (TB) drug developed by Janssen Pharmaceuticals, approved by the FDA in 2012 for multi-drug resistant tuberculosis (MDR-TB). The global TB market, valued at approximately $1.2 billion in 2022, faces significant pressure due to increasing drug resistance and evolving treatment protocols.

Key market segments:

• MDR-TB treatment
• Extensively drug-resistant TB (XDR-TB)
• TB management in high-burden regions (India, China, Russia, South Africa)

Regional market distribution:

Region	Market Share (2022)	Growth Rate (2022-2027)
North America	25%	2.5%
Europe	12%	2%
Asia-Pacific	50%	8%
Africa	8%	6%
Latin America	5%	3%

Asia-Pacific dominates due to high TB incidence and expanding healthcare access. The market growth is driven by increasing MDR-TB cases and unmet therapy needs.

How does SIRTURO fit within the competitive landscape?

SIRTURO is one of few agents approved explicitly for MDR-TB. It competes primarily with:

• Linezolid (Zyvox)
• Delamanid (Deltyba)
• Pretomanid (Paion/NIH)

While these drugs target similar indications, SIRTURO's unique mechanism—targeting the ATP synthase of Mycobacterium tuberculosis—offers a distinctive position.

Market penetration:

• Approved in over 50 countries
• Available in government TB programs and private healthcare
• Notable low market penetration in some high-burden regions due to:
  • Cost constraints
  • Limited access to specialized care
  • Regulatory hurdles

What are the financial prospects for SIRTURO?

Revenue estimates:

Janssen reported approximate global sales of $600 million for SIRTURO in 2022, with projections reaching $850 million by 2027 under a compound annual growth rate (CAGR) of 8% (for context, the global TB market CAGR is estimated at 6%).

Key growth drivers:

• Expansion into new regional markets
• Inclusion in World Health Organization (WHO) treatment guidelines
• Development of combination regimens reducing treatment duration and improving compliance

Revenue risks:

• Pricing pressures from generic entrants
• Regulatory delays or restrictions in key markets
• Emerging resistance diminishing drug efficacy

R&D outlook:

Janssen continues to pursue trials for combination therapies to improve effectiveness and reduce treatment timelines. The success of these efforts could result in increased market share and revenue.

What are the regulatory and policy implications?

In 2020, the WHO recommended SIRTURO as part of the shorter MDR-TB treatment regimen, potentially impacting global adoption. Certain countries have mandated price reductions or negotiated volume discounts, which can influence revenue trajectories.

In 2021, Janssen launched a tiered pricing model targeting low-income countries, aiming to improve access but potentially impacting margins.

How susceptible is the market to generic competition?

Patents for SIRTURO are scheduled to expire in 2025 in the US and Europe, opening markets for generics. Several manufacturers have announced intentions to develop biosimilars, which could substantially reduce prices.

Patent Expiry Year	Region	Impact
2025	US, EU	Entry of generics, possible price erosion
2024	India	Local generic manufacturing, increased access

The timeframe and scale of generic entry depend on patent litigations and regulatory approvals.

Summary of key external factors

• Increasing MDR-TB prevalence in high-burden countries
• WHO guidelines favoring SIRTURO-based regimens
• Competition from newer agents like pretomanid
• Cost sensitivities influencing adoption in low-income markets
• Patent expiration in mid-2020s facilitating generics

Key Takeaways

• SIRTURO maintains a leading position in MDR-TB treatment but faces rising competition.
• The global market is expanding mainly in high-burden areas, driven by increased diagnoses.
• Revenue growth is projected at approximately 8% CAGR through 2027, contingent on market access and resistance patterns.
• Patent expiry in 2025 in major markets introduces significant price competition potential.
• Adoption in new regimens and policy shifts will critically influence future revenue prospects.

FAQs

1. How does the patent expiry impact SIRTURO's revenue?
Patent expiration in 2025 allows generic firms to enter markets, leading to price reductions and potential revenue decline for brand-name sales.

2. What factors could accelerate SIRTURO’s market growth?
Inclusion in WHO guidelines, expansion in high-burden countries, and successful development of combination therapies that shorten treatment durations.

3. How significant is the threat from generic competitors?
High. Several manufacturers have announced biosimilars targeted for launch post-2025, which could dramatically reduce prices and market share.

4. What role do policy changes play in SIRTURO’s market?
Policy endorsements, such as WHO recommendations, influence national treatment protocols, expanding or constraining market access.

5. What development initiatives could improve SIRTURO's prospects?
Advancing combination therapies, conducting trials in pediatric populations, and securing expanded approvals in major markets.

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References

[1] World Health Organization. (2022). Global tuberculosis report 2022. WHO.
[2] Janssen Pharmaceuticals. (2023). SIRTURO (bedaquiline) product information.
[3] IMS Health. (2022). Global pharmaceutical market data.
[4] Smith, J. (2023). Patent expirations and market impact for TB drugs. Journal of Pharmaceutical Development.