SIRTURO Drug Patent Profile

When do Sirturo patents expire, 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 June 21, 2027. 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

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 REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST MARKETING REQUIREMENT 1988-001.

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

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
South Africa	200903907	FUMARATE SALT OF (ALPHA S,BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Serbia	20050058	DERIVATI HINOLINA I NJIHOVA UPOTREBA KAO MIKOBAKTERIJSKIH INHIBITORA (QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS)
Austria	463482

Supplementary Protection Certificates for SIRTURO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	CA 2014 00044	Denmark		PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE-ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
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	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	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

SIRTURO (Bedaquiline) Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

SIRTURO, the brand name for bedaquiline, is a diarylquinoline antimycobacterial drug used for the treatment of multidrug-resistant tuberculosis (MDR-TB). Its efficacy and novel mechanism of action have established it as a critical component in global TB treatment regimens. Analysis of its patent landscape and market fundamentals is essential for evaluating investment opportunities.

What is the Current Market Position of SIRTURO?

Bedaquiline is marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It is a first-line drug for the treatment of MDR-TB, often used in combination with other anti-TB agents. The World Health Organization (WHO) recommends bedaquiline as part of shorter, all-oral treatment regimens for drug-resistant TB [1]. This recommendation has driven global uptake.

The market for MDR-TB treatment is characterized by a significant unmet medical need. Tuberculosis remains a leading cause of death globally, and MDR-TB presents a more challenging and expensive treatment scenario with lower cure rates and higher toxicity profiles associated with older drugs [2]. Bedaquiline's introduction represented a significant advancement in addressing this unmet need.

What is the Patent Landscape for SIRTURO?

The intellectual property surrounding bedaquiline is complex, with multiple patents covering its composition of matter, methods of use, and manufacturing processes. The primary patent for bedaquiline was filed by Janssen Pharmaceutica NV.

• Composition of Matter Patents: The core patent covering the bedaquiline molecule itself has expired in many key markets. For instance, the U.S. composition of matter patent expired in 2021. However, secondary patents and formulation patents can extend market exclusivity.
• Method of Use Patents: Patents covering specific therapeutic uses of bedaquiline, such as its use in combination therapy for MDR-TB, can provide additional layers of protection. These patents are crucial for maintaining market advantage even after the primary compound patent expires.
• Formulation and Polymorph Patents: Patents related to specific drug formulations or crystalline forms (polymorphs) of bedaquiline can also offer extended exclusivity by protecting improved drug delivery or stability characteristics.
• Manufacturing Process Patents: While less common for blocking market entry, patents on novel or efficient manufacturing processes can be valuable assets.

The expiration of primary composition of matter patents opens the door for generic competition. However, the development of generic versions of complex drugs like bedaquiline involves significant regulatory hurdles and may face challenges from existing secondary patents.

What is the Patent Exclusivity Timeline for SIRTURO?

The timeline of patent exclusivity for bedaquiline varies by jurisdiction. Key dates for the original composition of matter patent in major markets are critical for understanding generic entry timelines.

• United States: The primary U.S. composition of matter patent for bedaquiline (U.S. Patent No. 7,393,867) expired in 2021. However, other patents related to formulations and methods of use may extend market protection.
• Europe: The European Patent EP1500373B1, covering the composition of matter, expired in 2024. Unitary Supplementary Protection Certificates (SPCs) in Europe can extend protection beyond the patent's expiration date.
• Other Major Markets: Patent expiration dates in countries like Japan, Canada, and Australia also follow a similar trajectory, with core compound patents generally expiring in the early to mid-2020s.

The interplay of patent expiry dates, regulatory exclusivities (such as data exclusivity), and potential patent litigation will determine the precise timing of generic market entry.

What are the Key Market Drivers and Restraints for SIRTURO?

Several factors influence the market demand and adoption of SIRTURO.

Market Drivers:

• Unmet Medical Need: The persistent global burden of MDR-TB necessitates effective and novel treatment options.
• WHO Recommendations: Inclusion in WHO treatment guidelines is a primary driver of adoption by national TB programs and procurement agencies. The shorter, all-oral regimens are particularly attractive due to improved patient adherence and reduced treatment duration compared to older regimens.
• Efficacy and Safety Profile: Bedaquiline offers improved efficacy and a more manageable safety profile compared to some older drugs used for MDR-TB, particularly with shorter regimens.
• Global Health Initiatives: Funding and support from organizations like the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID facilitate access to essential TB medicines in low- and middle-income countries.

Market Restraints:

• Cost: Bedaquiline remains a relatively expensive drug, posing a challenge for resource-limited settings. While prices have decreased, affordability remains a concern.
• Generic Competition: As primary patents expire, the threat of lower-cost generic alternatives increases.
• Drug Resistance: While effective, the potential for the development of bedaquiline resistance among TB strains is a long-term concern.
• Regulatory Hurdles for Generics: The process for approving generic versions of complex drugs is rigorous and can delay market entry.

What are the Regulatory Considerations for SIRTURO and its Competitors?

Regulatory approval is paramount for any drug. For SIRTURO, and any potential generic entrants, adherence to stringent regulatory standards is crucial.

• FDA Approval: SIRTURO received FDA approval in December 2012 for use in combination with other medicines to treat adults with pulmonary MDR-TB [3].
• EMA Approval: The European Medicines Agency (EMA) granted marketing authorization in 2014.
• WHO Prequalification: WHO prequalification of bedaquiline ensures that it meets international quality, safety, and efficacy standards, facilitating its procurement by UN agencies and national TB programs.
• Generic Drug Approvals: Generic manufacturers must demonstrate bioequivalence to the reference product (SIRTURO) and meet all manufacturing and quality standards set by regulatory authorities. This includes proving the absence of significant impurities and establishing the stability of the generic formulation.

The regulatory pathway for generic MDR-TB drugs is becoming more streamlined, with initiatives like the Florence Agreement aiming to expedite access to quality-assured TB medicines [4].

What is the Competitive Landscape for SIRTURO?

The competitive landscape for MDR-TB treatment is evolving, with bedaquiline currently holding a dominant position in WHO-recommended regimens. However, other drugs and drug classes are either on the market or in development.

• Pre-Bedaquiline Era: Treatment for MDR-TB relied on older, less effective drugs with significant toxicities, often requiring regimens of 18-24 months.
• Emerging Competitors:
  • Delamanid: Another novel drug for MDR-TB, delamanid, offers an alternative mechanism of action. It is often used in combination with bedaquiline or other agents.
  • Grt-303 (Gepotidacin): This is an investigational oral antibiotic that has shown promise in early-stage clinical trials for certain drug-resistant infections, including TB. Its development could present a future alternative.
  • New Combination Regimens: Research is ongoing to develop even shorter, more effective, and safer MDR-TB regimens, which may incorporate existing drugs in novel combinations or new chemical entities.
• Generic Bedaquiline: The primary competitive threat will come from generic versions of bedaquiline once patents fully expire and regulatory approvals are secured.

The therapeutic landscape is shifting towards shorter, all-oral regimens, which bedaquiline facilitates. This trend will continue to shape the competitive environment.

What are the Financial and Investment Fundamentals for SIRTURO?

The investment thesis for SIRTURO is tied to its critical role in treating a global health crisis, its established market position, and the ongoing need for effective MDR-TB therapies.

• Revenue: Janssen, through Johnson & Johnson, generates revenue from SIRTURO sales. Sales figures are part of J&J's Pharmaceutical segment reporting. While specific revenue breakdowns for individual drugs are not always disclosed, the global need for MDR-TB treatment suggests significant market potential.
• Pricing: The price of SIRTURO has been a subject of negotiation, particularly with global procurement agencies. Initiatives by organizations like UNITAID and the Medicines Patent Pool (MPP) have aimed to negotiate lower prices for bedaquiline in low- and middle-income countries, facilitating broader access while also impacting revenue.
• R&D Investment: Significant R&D investment was required to discover, develop, and gain regulatory approval for bedaquiline. Ongoing R&D focuses on optimal use in various patient populations and new treatment regimens.
• Market Access and Distribution: Ensuring access in resource-limited settings is crucial. Partnerships with global health organizations and manufacturing agreements are key to broad distribution.
• Generic Entry Impact: The eventual entry of generic bedaquiline will likely lead to price erosion, impacting the revenue stream for the originator product. However, it also increases overall market volume by improving affordability. This dynamic presents both challenges and opportunities for stakeholders across the value chain.

Key Takeaways

• SIRTURO (bedaquiline) is a critical treatment for multidrug-resistant tuberculosis (MDR-TB), driven by WHO recommendations and global health needs.
• The patent landscape is characterized by the expiration of core composition of matter patents, creating an avenue for generic competition, while secondary patents may offer extended exclusivity.
• Market exclusivity for bedaquiline is phasing out in major markets, with U.S. composition of matter patents expiring in 2021 and European patents in 2024.
• Market drivers include the high unmet need for MDR-TB treatment and the drug's efficacy in WHO-recommended regimens, while restraints include its cost and the potential for generic entry.
• Regulatory approval by major agencies like the FDA and EMA, along with WHO prequalification, underpins SIRTURO's market access.
• The competitive landscape includes other novel drugs like delamanid and emerging research into new combination therapies.
• Investment fundamentals are influenced by revenue generated from a critical unmet need, pricing negotiations, R&D investment, and the eventual impact of generic competition on market dynamics.

Frequently Asked Questions

1. When will generic versions of SIRTURO become widely available? The availability of generic SIRTURO depends on the expiration of all relevant patents and the successful approval of generic drug applications by regulatory authorities. While primary composition of matter patents have expired or are expiring, secondary patents and formulation patents may create delays. Generic entry is expected to become more prevalent in the mid-to-late 2020s in various regions.

2. What is the primary mechanism of action for bedaquiline? Bedaquiline targets the ATP synthase enzyme in Mycobacterium tuberculosis, which is essential for energy production within the bacterium. By inhibiting this enzyme, bedaquiline disrupts the bacterium's ability to generate energy, leading to cell death.

3. How does the cost of SIRTURO compare to older MDR-TB treatments? Historically, SIRTURO has been more expensive than older, generic MDR-TB drugs. However, through price negotiations and volume commitments by global health organizations, the cost in low- and middle-income countries has decreased significantly, making it more accessible.

4. What are the main challenges in developing generic bedaquiline? Developing generic bedaquiline involves overcoming complex chemical synthesis, meeting stringent bioequivalence requirements, and navigating a potentially complex patent landscape. Manufacturing also requires specialized facilities and adherence to Good Manufacturing Practices (GMP).

5. What are the long-term implications of bedaquiline resistance? The development of bedaquiline resistance would be a significant setback for MDR-TB treatment. Continuous surveillance of drug resistance patterns and responsible drug use are crucial to mitigate this risk. Research into second-generation bedaquiline analogs or alternative treatment strategies is also ongoing.

Citations

[1] World Health Organization. (2020). WHO consolidated guidelines on drug-resistant tuberculosis: treatment. World Health Organization. [2] Global tuberculosis report 2023. (2023). World Health Organization. [3] U.S. Food and Drug Administration. (2012, December 27). FDA approves new drug for treatment-resistant tuberculosis. [Press release]. [4] Medicines Patent Pool. (n.d.). Tuberculosis. Retrieved from https://www.medicinespatentpool.org/tuberculosis/