SIRTURO Drug Patent Profile

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

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

See drug prices for SIRTURO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SIRTURO

Constraining patent/regulatory exclusivity:

8,546,428

NDA:

204384

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

Sponsor	Phase
Tuberculosis Trials Consortium	Phase 2/Phase 3
Centers for Disease Control and Prevention	Phase 2/Phase 3
Beijing Chest Hospital	Phase 4

See all SIRTURO clinical trials

Pharmacology for SIRTURO

Drug Class

Diarylquinoline Antimycobacterial

US Patents and Regulatory Information for SIRTURO

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

This potential generic entry date is based on patent 8,546,428.

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
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	7,498,343		Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No

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
Slovenia	1527050
Taiwan	I417098
Denmark	1527050
Jordan	2973	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)
Argentina	064149	SAL FUMARATO DE (ALFA S , BETA R)-6 BROMO- ALFA-[ 2(DIMETILAMINO ) ETIL)-2- METOXI - ALFA-1-NAFTALENIL- BETA- FENIL-3- QUINOLINAETANOL
China	1671667	Quinoline derivatives and their use as mycobacterial inhibitors

Supplementary Protection Certificates for SIRTURO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	SPC/GB14/057	United Kingdom		PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTERED: UK EU/1/13/901 20140307
1527050	122014000083	Germany		PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050	178 5021-2014	Slovakia		PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050	PA2014032	Lithuania		PRODUCT NAME: BEDAQUILINUM; 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	C20140026 00112	Estonia		PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014

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]