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

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			Y	Y
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
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

International Patents for bedaquiline fumarate

Country	Patent Number	Title	Estimated Expiration
South Korea	20090087020	FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Japan	2006504658
New Zealand	538391	Quinoline derivatives and their use as mycobacterial inhibitors
Jordan	2973
Hong Kong	1214513
African Regional IP Organization (ARIPO)	2498

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	178 5021-2014	Slovakia		PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: 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	1490050-0	Sweden		PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REG. NO/DATE: EU/1/13/901 20140305
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	50/2014	Austria		PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307

Bedaquiline Fumarate: Market Dynamics and Financial Trajectory

Last updated: March 4, 2026

What is the current market landscape for Bedaquiline Fumarate?

Bedaquiline Fumarate, marketed as Sirturo, is a novel antibiotic developed by Johnson & Johnson. Approved by the FDA in 2012 for multidrug-resistant tuberculosis (MDR-TB), it has transformed TB management by targeting bacteria resistant to conventional therapies. The drug's global adoption depends on TB prevalence, treatment guidelines, and regulatory approvals.

The global MDR-TB market was valued at approximately USD 0.5 billion in 2022, with projections reaching USD 0.75 billion by 2030, growing at a CAGR of 4.5% (ResearchAndMarkets, 2022). Bedaquiline contributes significantly to this sector, representing roughly 60% of the MDR-TB drug sales.

What influences the market penetration of Bedaquiline Fumarate?

Regulatory approvals and guidelines

Bedaquiline's inclusion in WHO guidelines in 2018 expanded its global footprint. When endorsed, many countries accelerated approval processes. The drug received full approval from the FDA in 2019, setting a precedent for other regulators.

Patent status and generic competition

Patent protections last until 2027 in the U.S. and Europe. Patent expirations could open markets for generics, reducing prices and expanding access. No significant generic versions are currently available due to patent enforcement and regulatory barriers.

Pricing strategies and reimbursement policies

Johnson & Johnson employed premium pricing, with a typical course costing USD 3,000–USD 5,000 in high-income countries. Many low- and middle-income nations rely on donor funding, subsidies, or generic markets to facilitate access.

Market drivers and barriers

The rising incidence of MDR-TB in Asia and Africa drives demand. However, concerns about side effects (QT prolongation) and the need for careful monitoring limit widespread use. The high cost remains a barrier in resource-limited settings.

What is the financial trajectory forecast for Bedaquiline?

Revenue estimates

Johnson & Johnson reported sales of USD 340 million from Bedaquiline in 2022, accounting for approximately 15% of its infectious disease portfolio. The company projects steady growth at a CAGR of 7%, reaching USD 560 million by 2025, due to increased adoption in Asia, Africa, and Latin America.

Market expansion opportunities

• Regulatory approvals: Several emerging markets are progressing towards approval, including India, Brazil, and South Africa.
• Clinical trials: Ongoing Phase III studies address pediatric populations and shorter treatment regimens, potentially broadening indications.
• Combination therapies: Bedaquiline’s integration into all-oral MDR-TB regimens enhances treatment adherence, supporting long-term market penetration.

Risks influencing financial forecasts

• Patent expiry: Approaching patent expiration in 2027 risks generic entry, which could cut prices by 70–80%, significantly impacting revenue.
• Pricing pressures: Negotiations in low-income countries may reduce unit prices.
• Safety concerns: Adverse effects, such as QT prolongation, could lead to regulatory restrictions limiting sales.

How does Bedaquiline compare to competing therapies?

Therapy	Approval Year	Indication	Price (USD) per course	Market Share (2022)
Bedaquiline	2012	MDR-TB	3,000–5,000	60%
Linezolid	2015	MDR-TB	1,200	20%
Delamanid	2014	MDR-TB	2,500	10%
Others	N/A	Various	Variable	10%

What recent developments could influence future market and financial outcomes?

• Regulatory updates: The US FDA and EMA are reviewing data for pediatric indications and shorter regimens.
• Patent challenges: Patent filings and legal disputes may delay generic entry.
• Global health initiatives: The Global Fund and WHO prioritize MDR-TB treatment, increasing demand.
• Pricing reforms: Countries like India and South Africa are negotiating drug prices, impacting margins.

Key Takeaways

• Bedaquiline Fumarate commands a significant share in the MDR-TB treatment market, with steady growth likely until patent expiry in 2027.
• Global adoption hinges on regulatory approvals, pricing strategies, and management of safety concerns.
• Revenue forecasts anticipate reaching USD 560 million by 2025, driven by expanding access in emerging markets.
• Competitive dynamics include developing generic versions and integration into combination regimens.
• Pending patent expirations and pricing reforms pose risks to long-term profitability.

FAQs

1. What is the primary indication for Bedaquiline?
   MDR-TB, especially multidrug-resistant strains unresponsive to first-line therapies.

2. When will generic versions of Bedaquiline become available?
   Post-2027, following patent expiration and legal processes.

3. What safety concerns are associated with Bedaquiline?
   QT prolongation and potential cardiac arrhythmias necessitate monitoring.

4. Are there ongoing trials for expanding Bedaquiline use?
   Yes, trials include pediatric populations and shorter, all-oral regimens.

5. How does pricing impact access in low-income countries?
   High prices limit access; subsidies and generic competitors are crucial for affordability.

References

[1] ResearchAndMarkets. (2022). Global MDR-TB market report.
[2] World Health Organization. (2018). Consolidated guidelines on drug-resistant tuberculosis treatment.
[3] Johnson & Johnson. (2023). Annual report.