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
Patent Applications:	157
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			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

International Patents for bedaquiline fumarate

Country	Patent Number	Title	Estimated Expiration
China	1325475
World Intellectual Property Organization (WIPO)	2004011436
China	101547904	Fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Malaysia	143564	QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS
Hong Kong	1083496	Quinoline derivatives and their use as mycobacterial inhibitors
Uruguay	30762	SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO) ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL

Supplementary Protection Certificates for bedaquiline fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	178 5021-2014	Slovakia		PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
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	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	C20140026 00112	Estonia		PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014

Bedaquiline Fumarate: Market Dynamics and Financial Trajectory

Introduction

Bedaquiline fumarate, sold under the brand name Sirturo, is a crucial medication in the treatment of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). This article delves into the market dynamics and financial trajectory of bedaquiline fumarate, highlighting its pricing, market access, and the impact of recent developments on its availability and affordability.

Medical Uses and Approval

Bedaquiline fumarate was approved by the US Food and Drug Administration (FDA) in December 2012 for the treatment of MDR-TB and XDR-TB. It is recommended by both the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) for use in cases where other treatment regimens cannot be designed[2].

Market Size and Growth

The global bedaquiline fumarate market has been expanding, driven by the increasing need for effective treatments against drug-resistant TB. As of 2018, the market size was valued at a significant figure, and it is projected to grow at a notable Compound Annual Growth Rate (CAGR) from 2019 to 2025[1].

Pricing and Affordability

The cost of bedaquiline fumarate varies significantly across different income groups of countries. In low-income countries, the cost is approximately $900 for a six-month treatment course, while in middle-income countries it is around $3,000, and in high-income countries, it can be as high as $30,000[2].

Recent Price Reductions

In recent years, there have been significant efforts to reduce the price of bedaquiline fumarate to make it more accessible. The Stop TB Partnership's Global Drug Facility (GDF) has played a crucial role in this. In August 2023, the GDF announced price reductions of up to 55% for bedaquiline, with Johnson & Johnson agreeing to supply the drug at $130 per 6-month treatment course, a reduction from the previous price of $289[5].

Country-Specific Agreements

In South Africa, Johnson & Johnson agreed to lower the price of bedaquiline by 40% and to withdraw a secondary patent, allowing generic suppliers to produce the drug. This move is expected to increase access to affordable bedaquiline in the country[3].

Patent and Generic Production

The patent landscape for bedaquiline fumarate has been a subject of controversy. In July 2023, the Indian patent office rejected Johnson & Johnson's request to extend the patent on bedaquiline until 2027, paving the way for generic production. Similarly, in South Africa, the withdrawal of a secondary patent by Johnson & Johnson has opened the market for generic suppliers[2][3].

Impact on Generic Production

The agreement between Johnson & Johnson and the Stop TB Partnership's GDF to allow generic production in low- and middle-income countries has been a significant step. This has enabled countries to purchase bedaquiline at lower prices, increasing access to the drug for patients in need[5].

Financial Investments and Costs

The development of bedaquiline fumarate involved substantial financial investments. The public sector invested between $455 million and $747 million, which is estimated to be 1.6 to 5.1 times the investment made by Janssen Biotech, the owner of the drug[2].

Cost Savings and Procurement

The reduced prices negotiated by the GDF are expected to generate significant cost savings. For instance, the new prices are estimated to save $8 million over a 16-month contract period, which can procure more than 51,000 additional bedaquiline treatments[5].

Market Dynamics and Competition

The market for bedaquiline fumarate is influenced by several factors, including regulatory approvals, patent status, and competitive pricing. The entry of generic suppliers, facilitated by the withdrawal of secondary patents and licensing agreements, is expected to increase competition and drive prices down further[3].

Role of Regulatory Bodies

Regulatory bodies such as the Indian Patent Office and South Africa's Competition Commission have played a critical role in ensuring that the market remains competitive and that generic alternatives are available. These actions have helped in reducing the monopoly held by Johnson & Johnson and promoting a more equitable access to the drug[2][3].

Impact on Treatment Regimens

Bedaquiline fumarate is a core component of the WHO-recommended regimens for treating DR-TB, including the BPaLM and BPaL regimens. The reduction in bedaquiline prices has led to an overall decrease in the cost of these treatment regimens by 27% to 29%[5].

Patient Access and Advocacy

Patient advocacy groups and non-governmental organizations like Médecins Sans Frontières (MSF) have been instrumental in pushing for lower prices and greater access to bedaquiline fumarate. Their efforts have led to significant price reductions and increased availability of the drug in low- and middle-income countries[3].

Future Outlook

The future outlook for the bedaquiline fumarate market is promising, with continued efforts to reduce prices and increase access. The entry of more generic suppliers and the expansion of licensing agreements are expected to further drive down costs and improve treatment outcomes for patients with DR-TB.

Key Takeaways

• Pricing and Affordability: Significant price reductions have been achieved, making bedaquiline fumarate more accessible in low- and middle-income countries.
• Generic Production: The withdrawal of secondary patents and licensing agreements have enabled generic production, increasing competition and reducing costs.
• Regulatory Impact: Regulatory bodies have played a crucial role in ensuring competitive market conditions and promoting equitable access.
• Treatment Regimens: The drug is a key component of WHO-recommended regimens, and price reductions have led to overall cost savings in DR-TB treatment.
• Patient Access: Advocacy efforts have been instrumental in improving access to bedaquiline fumarate.

FAQs

What is bedaquiline fumarate used for?

Bedaquiline fumarate is used for the treatment of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB)[2].

How much does bedaquiline fumarate cost?

The cost varies by country, but recent reductions have brought the price down to $130 per 6-month treatment course in many low- and middle-income countries[5].

Why is there controversy over the approval of bedaquiline fumarate?

There is controversy due to higher mortality rates observed in patients treated with bedaquiline fumarate compared to those receiving a placebo, leading to recommendations for limited use and a black box warning[2].

What role has the Stop TB Partnership's Global Drug Facility played in reducing bedaquiline prices?

The GDF has negotiated significant price reductions with manufacturers, securing prices as low as $130 per 6-month treatment course, and has facilitated the production of generic versions of the drug[5].

How have regulatory bodies influenced the market for bedaquiline fumarate?

Regulatory bodies have ensured that secondary patents are not enforced, allowing generic production and increasing competition, which has driven prices down and improved access to the drug[2][3].

Sources

1. Prof-Research: Bedaquiline Fumarate Market Size, Share, Trend and Forecast to 2025.
2. Wikipedia: Bedaquiline.
3. CIDRAP: J&J agrees to lower price of TB drug bedaquiline, allow production in South Africa.
4. Dataintelo: Bedaquiline Fumarate API Market Research Report 2032.
5. Stop TB Partnership: Stop TB's Global Drug Facility Announces Historic Price Reductions for Bedaquiline.

Last updated: 2024-12-19