Explore More Than Just This Free Article

This article is a glimpse of the exclusive insights we provide daily to industry leaders. Dive deeper into our industry-specific reports and uncover the strategic information you need.

Johnson & Johnson Confirms Intent Not to Enforce Patents for SIRTURO® (bedaquiline) for the Treatment of Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries

September 29, 2023 (press release) –

New Brunswick, N.J. (September 29, 2023) – Johnson & Johnson (the “Company”) (NYSE: JNJ) today confirmed its intent not to enforce patents it owns and controls for SIRTURO® (bedaquiline) in the treatment of multidrug-resistant tuberculosis (MDR-TB) in 134 low- and middle-income countries1,2.

The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of SIRTURO® without a concern that the Company will allege them of infringing its bedaquiline patents; provided the generic versions of SIRTURO® produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low- and middle-income countries.

“Underdiagnosis remains the most significant barrier to treatment, with nearly two-thirds of the 450,000 people who develop MDR-TB each year not diagnosed and enrolled on treatment,” said Howard Reid, Global Head, Global Public Health & Social Impact, Johnson & Johnson. “This addresses any misperception that access to our medicine is limited or restricted and builds on our decade of investments in collaborative efforts to help countries sustainably scale up access and bring people living with MDR-TB into treatment.”

Johnson & Johnson introduced SIRTURO® (bedaquiline), the first targeted tuberculosis (TB) medicine with a novel mechanism of action in more than 40 years, in 2012 after years of focused investments in R&D. In partnership with many others, the Company has spent the past decade investing in critical TB systems capacity, such as healthcare professional training, resistance testing and surveillance, and supply chain security, to help bring people into treatment while not compromising the effectiveness as drug resistance increases globally.

Today, thanks to years of investments, collaboration, and responsible use of our intellectual property, bedaquiline is the backbone of World Health Organization-recommended treatment guidelines for drug-resistant TB, and three of every four MDR-TB patients on treatment are receiving a bedaquiline-containing regimen.

Most recently, Johnson & Johnson granted Stop TB Partnership´s Global Drug Facility`s (GDF) a license that enabled GDF to tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries. The Company will continue to invest in innovative capacity building, surveillance and patient finding efforts that drive access and appropriate use of bedaquiline.

References:
1 World Bank Income Classifcation set on 1 July 2022: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups
2 The list of low- and middle-income countries is available upon request.

###

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com. 

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements as they are based on current expectations of future events. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from current expectations. A list and descriptions of risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.  

© Janssen Pharmaceutica NV, Inc. 2023. All rights reserved.

* All content is copyrighted by Industry Intelligence, or the original respective author or source. You may not recirculate, redistrubte or publish the analysis and presentation included in the service without Industry Intelligence's prior written consent. Please review our terms of use.

See our dashboard in action - schedule an demo with Chelsey
Chelsey Quick
Chelsey Quick
- VP Client Success -

We offer built-to-order consumer packaged goods (cpg) coverage for our clients. Contact us for a free consultation.

About Us

We deliver market news & information relevant to your business.

We monitor all your market drivers.

We aggregate, curate, filter and map your specific needs.

We deliver the right information to the right person at the right time.

Our Contacts

1990 S Bundy Dr. Suite #380,
Los Angeles, CA 90025

+1 (310) 553 0008

About Cookies On This Site

This website stores cookies on your computer. These cookies are used to improve your website experience and provide more personalized services to you, both on this website and through other media. To find out more about the cookies we use, see our Privacy Policy. We won't track your information when you visit our site. But in order to comply with your preferences, we'll have to use just one tiny cookie so that you're not asked to make this choice again.