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Last Updated: December 22, 2024

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SIRTURO Drug Patent Profile


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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

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Summary for SIRTURO
International Patents:97
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 37
Clinical Trials: 16
Patent Applications: 46
Drug Prices: Drug price information for SIRTURO
What excipients (inactive ingredients) are in SIRTURO?SIRTURO excipients list
DailyMed Link:SIRTURO at DailyMed
Drug patent expirations by year for SIRTURO
Drug Prices for SIRTURO

See drug prices for SIRTURO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIRTURO
Generic Entry Date for SIRTURO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Centers for Disease Control and PreventionPhase 2/Phase 3
Tuberculosis Trials ConsortiumPhase 2/Phase 3
Beijing Chest HospitalPhase 4

See all SIRTURO clinical trials

Pharmacology for SIRTURO

US Patents and Regulatory Information for SIRTURO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIRTURO is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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)

Patent: 98
Patent: Fumarate salt of (ALPHA S, BETA R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷  Subscribe

Argentina

Patent: 4149
Patent: SAL FUMARATO DE (ALFA S , BETA R)-6 BROMO- ALFA-[ 2(DIMETILAMINO ) ETIL)-2- METOXI - ALFA-1-NAFTALENIL- BETA- FENIL-3- QUINOLINAETANOL
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 07328945
Patent: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0719693
Patent: SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2- (DEMETILAMINO)ETIL]-2-METÓXI-ALFA-1-NAFTALENIL-BETA- FENIL-3-QUINOLINAETANOL
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 68512
Patent: SEL DE FUMARATE DE (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTALENYL-BETA-PHENYL-3-QUINOLEINEETHANOL (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 07003472
Patent: SAL FUMARATO DE (ALFA S,BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL; PROCESO DE PREPARACION; COMPOSICION FARMACEUTICA; PROCESO DE PREPARACION DE LA COMPOSICION FARMACEUTICA; Y USO EN EL TRATAMIE
Estimated Expiration: ⤷  Subscribe

China

Patent: 1547904
Patent: Fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷  Subscribe

Patent: 5012303
Patent: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0120639
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 13594
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 86940
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 7091
Patent: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

Patent: 0970532
Patent: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 86940
Patent: SEL DE FUMARATE DE (ALPHA S, BÊTA R)-6-BROMO-ALPHA-[2-(DIMÉTHYLAMINO)ÉTHYL]-2-MÉTHOXY-ALPHA-1-NAPHTALÉNYL-BÊTA-PHÉNYL-3-QUINOLÉINEÉTHANOL (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 14513
Patent: ,β -溴-α- 二甲胺基 乙基 -甲氧基-α- -萘基-β-苯基- -喹啉乙醇的富馬酸鹽 (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2- (DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL- BETA-PHENYL-3- QUINOLINEETHANOL (SR)-6---[2-()]-2---1----3-)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 9077
Patent: תכשיר רוקחי למתן פומי המכיל מלח פומאראט של (אלפא s, בטא r)-6-ברומו-אלפא-[2-(דימתילאמינו)אתיל]-2-מתוקסי-אלפא-1-נפתלניל-בטא-פניל-3-קווינולינאתנול וגורם הרטבה, שימושים ותהליך להכנת חומר פעיל (Pharmaceutical composition suitable for oral administration comprising fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol and a wetting agent, uses and process for active compound preparation)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 94239
Estimated Expiration: ⤷  Subscribe

Patent: 10511663
Estimated Expiration: ⤷  Subscribe

Patent: 15028049
Patent: (アルファS,ベータR)−6−ブロモ−アルファ−[2−(ジメチルアミノ)エチル]−2−メトキシ−アルファ−1−ナフタレニル−ベータ−フェニル−3−キノリンエタノールのフマル酸塩 (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

Jordan

Patent: 73
Patent: ملح فيوميريت ل(الفا اس، بيتا ار)-6-برومو-الفا-[2-(ميثيل امينو)ايثيل] -2- ميثوكسي -الفا-1- نفثالينيل- بيتا- فينيل-3- كوينولين ايثانول (Fumarate Salt Of (alphaS, betaR)-6-Bromo-alfa-[2-(dimethylamino)ethyl]-2- Methoxy-alpha-1-naphthalenyl-beta-phenyl-3- Quinolineethanol)
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 8844
Patent: FUMARATE SALT OF (ALPHA S, BETA R)-6- BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 09005909
Patent: 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.)
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 456
Patent: FUMARATNA SO (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOKSI-ALFA-1-NAFTALENIL-BETA-FENIL-3-KINOLINETANOLA (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 6485
Patent: FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 2773
Estimated Expiration: ⤷  Subscribe

Patent: 092535
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 081350
Patent: SAL FUMARATO DE (ALFAS S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO)ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 86940
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 86940
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 408
Patent: FUMARATNA SO (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOKSI-ALFA-1-NAFTALENIL-BETA-FENIL-3-KINOLINETANOLA (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2¬METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUlNOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 86940
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 0903907
Patent: FUMARATE SALT OF (ALPHA S,BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1514700
Estimated Expiration: ⤷  Subscribe

Patent: 090087020
Patent: FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 87923
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 17098
Estimated Expiration: ⤷  Subscribe

Patent: 0838527
Patent: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 813
Patent: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА;ФУМАРАТНА СІЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМІНО)ЕТИЛ]-2-МЕТОКСІ-АЛЬФА-1-НАФТАЛЕНІЛ-БЕТА-ФЕНІЛ-3-ХІНОЛІНЕТАНОЛУ (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷  Subscribe

Uruguay

Patent: 762
Patent: SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO) ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL
Estimated Expiration: ⤷  Subscribe

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
Cyprus 1111882 ⤷  Subscribe
Peru 20081350 SAL FUMARATO DE (ALFAS S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO)ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL ⤷  Subscribe
Japan 2010511663 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIRTURO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 C 2014 034 Romania ⤷  Subscribe 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 122014000083 Germany ⤷  Subscribe PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 C20140026 00112 Estonia ⤷  Subscribe PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

SIRTURO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SIRTURO (Bedaquiline)

Introduction to SIRTURO

SIRTURO, also known as bedaquiline, is a groundbreaking drug developed by Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson, for the treatment of multidrug-resistant tuberculosis (MDR-TB). It was the first targeted medicine for TB with a novel mechanism of action introduced in over 40 years[4].

Market Size and Growth

The global tuberculosis drugs market, which includes SIRTURO, is projected to reach USD 1.38 billion by 2025, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period. This growth is driven by the rising prevalence of MDR-TB and HIV-TB co-infections, particularly in regions like India, which has the second highest estimation of HIV-TB co-infection cases per year[1].

Therapy Type and Market Share

Second-line therapy drugs, which include SIRTURO, led the market with a share of 60.4% in 2016. The high incidence and higher treatment cost structure of MDR-TB, coupled with increasing treatment access, are key factors driving the market growth for these drugs[1].

Regional Market Dynamics

  • Asia Pacific: This region holds a major market share and is expected to retain its dominance due to high disease incidence and gradual improvement in patient medication adherence rates[1].
  • Europe: Europe is likely to witness significant growth due to the high MDR-TB burden and improved focus on latent TB infection (LTBI) treatment drugs[1].

Regulatory Approvals and Expansions

SIRTURO has received several significant regulatory approvals:

  • FDA Approval: Initially granted accelerated approval by the FDA in December 2012, and later expanded to include pediatric patients aged 12-17 years in 2019[3][4].
  • EMA Approval: Conditional approval by the European Medicines Agency (EMA) in March 2014, with ongoing efforts for full approval through recent Phase 3 study data submissions[4].

Clinical Impact and Usage

SIRTURO is a core component of WHO-recommended treatment guidelines for drug-resistant TB. As of the latest reports, more than 700,000 courses of SIRTURO have been delivered to 159 countries, including those with the highest burdens of TB. Three out of every four MDR-TB patients on treatment are receiving a bedaquiline-containing regimen[4].

Pricing and Accessibility

To enhance accessibility, especially in low- and middle-income countries, Johnson & Johnson has implemented several pricing strategies:

  • Price Reduction: In collaboration with the Stop TB Partnership, the Global Fund, and USAID, the price of SIRTURO was reduced to USD $340 per six-month treatment course for eligible countries. Additional discounts are provided when certain volume thresholds are reached[5].
  • Generic Versions: Johnson & Johnson has granted a license to the Stop TB Partnership’s Global Drug Facility (GDF) to tender, procure, and supply generic versions of SIRTURO for low- and middle-income countries. The company has also committed not to enforce patents in 134 of these countries[4][5].

Financial Trajectory

Johnson & Johnson's investment in SIRTURO reflects its commitment to innovation and global health:

  • R&D Investment: The company invested $15.1 billion in R&D in 2023, which is almost 18% of its sales, highlighting its strong commitment to innovative medicines like SIRTURO[2].
  • Sales and Distribution: The delivery of over 800,000 courses of SIRTURO since 2014 indicates significant revenue generation from this drug. While exact financial figures for SIRTURO are not isolated, the overall performance of Johnson & Johnson's Innovative Medicine segment, which includes SIRTURO, has been strong, with above-market growth reported for the 12th consecutive year[2].

Key Players and Collaborations

The tuberculosis drugs market, including SIRTURO, involves several key players:

  • Johnson & Johnson: As the developer and primary marketer of SIRTURO, Johnson & Johnson plays a pivotal role.
  • Other Players: Companies like Lupin, Pfizer, Novartis AG, Macleods Pharmaceuticals Limited, and Otsuka Pharmaceutical Co., Ltd. are also significant in the market[1].
  • Collaborations: The success of SIRTURO is also due to collaborations with organizations like the Stop TB Partnership, the Global Fund, and USAID, which help in scaling up the treatment and making it more accessible[5].

Challenges and Opportunities

Despite the positive market dynamics, there are challenges and opportunities to consider:

  • Regulatory Compliance: Ensuring compliance with local regulations and laws, especially in diverse markets, is crucial[2].
  • Market Expansion: The growing need for MDR-TB treatments in various regions presents opportunities for market expansion and increased accessibility[1].

Key Takeaways

  • Market Growth: The global TB drugs market is expected to grow significantly, driven by the rise in MDR-TB cases.
  • Regulatory Approvals: SIRTURO has received critical regulatory approvals, including FDA and EMA clearances.
  • Accessibility: Pricing strategies and collaborations have improved the drug's accessibility in low- and middle-income countries.
  • Financial Impact: SIRTURO contributes to Johnson & Johnson's strong financial performance in the Innovative Medicine segment.
  • Global Health Impact: The drug is a core component of WHO-recommended treatment guidelines and has been delivered to numerous countries worldwide.

FAQs

  1. What is SIRTURO used for?

    • SIRTURO (bedaquiline) is used as part of combination therapy to treat pulmonary multidrug-resistant tuberculosis (MDR-TB).
  2. Who developed SIRTURO?

    • SIRTURO was developed by Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson.
  3. What is the current market size of the TB drugs market?

    • The global TB drugs market is expected to reach USD 1.38 billion by 2025.
  4. How has the pricing of SIRTURO been adjusted for low- and middle-income countries?

    • The price of SIRTURO has been reduced to USD $340 per six-month treatment course, with additional discounts for bulk orders, and Johnson & Johnson has committed not to enforce patents in 134 low- and middle-income countries.
  5. What is the significance of SIRTURO in global health?

    • SIRTURO is a core component of WHO-recommended treatment guidelines for drug-resistant TB and has been delivered to over 159 countries, making it a crucial drug in the global fight against MDR-TB.

Cited Sources

  1. Grand View Research Inc. - "TB Drugs Market Size Worth $1.38 Billion by 2025 | CAGR: 5.2%"[1]
  2. Johnson & Johnson - "2023 Annual Report"[2]
  3. Janssen Pharmaceutical Companies of Johnson & Johnson - "Janssen Announces U.S. FDA Accelerated Approval for SIRTURO (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis"[3]
  4. Janssen Pharmaceutical Companies of Johnson & Johnson - "Janssen Submits Phase 3 Study Data to the European Medicines Agency and U.S. Food and Drug Administration for SIRTURO (bedaquiline)"[4]
  5. Stop TB Partnership and Johnson & Johnson - "Stop TB Partnership and Johnson & Johnson, with support from USAID and The Global Fund, Announce Price Reduction for SIRTURO (bedaquiline) for Treatment of Drug-Resistant Tuberculosis in Low- and Middle-Income Countries"[5]

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.