Bosentan - Generic Drug Details

What are the generic drug sources for bosentan and what is the scope of freedom to operate?

Bosentan is the generic ingredient in two branded drugs marketed by Actelion, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, Natco Pharma Ltd, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bosentan has twenty-eight patent family members in twenty-three countries.

There are nineteen drug master file entries for bosentan. Six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for bosentan

International Patents:	28
US Patents:	2
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	131
Patent Applications:	6,614
Drug Prices:	Drug price trends for bosentan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bosentan
What excipients (inactive ingredients) are in bosentan?	bosentan excipients list
DailyMed Link:	bosentan at DailyMed

See drug prices for bosentan

Recent Clinical Trials for bosentan

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CTI BioPharma	Phase 1
PPD	Phase 1
Jean-Pierre Routy	N/A

See all bosentan clinical trials

Generic filers with tentative approvals for BOSENTAN

Applicant	Application No.	Strength	Dosage Form
		125MG	TABLET;ORAL
		62.5MG	TABLET;ORAL
		32MG	TABLET, FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bosentan

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for bosentan

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

Paragraph IV (Patent) Challenges for BOSENTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRACLEER	for Oral Suspension	bosentan	32 mg	209279	1	2019-02-08

US Patents and Regulatory Information for bosentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Inc	BOSENTAN	bosentan	TABLET;ORAL	207110-002	Apr 26, 2019	AB	RX	No	No
Alembic	BOSENTAN	bosentan	TABLET;ORAL	211461-002	Jan 23, 2020		DISCN	No	No
Chartwell Molecular	BOSENTAN	bosentan	TABLET;ORAL	210342-001	Jan 3, 2020		DISCN	No	No
Alvogen Pine Brook	BOSENTAN	bosentan	TABLET;ORAL	206002-002	Apr 26, 2019		DISCN	No	No
Mylan	BOSENTAN	bosentan	TABLET;ORAL	205173-002	Jan 15, 2020		DISCN	No	No
Hikma	BOSENTAN	bosentan	TABLET;ORAL	208695-001	Apr 26, 2019		DISCN	No	No
Zydus Pharms	BOSENTAN	bosentan	TABLET;ORAL	207760-001	Apr 26, 2019	AB	RX	No	No

Expired US Patents for bosentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	5,292,740
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	5,292,740

EU/EMA Drug Approvals for bosentan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Tracleer	bosentan	EMEA/H/C/000401 Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in:, , , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology., , , Some improvements have also been shown in patients with PAH WHO functional class II., , Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,	Authorised	no	no	no	2002-05-14

International Patents for bosentan

Country	Patent Number	Title	Estimated Expiration
Mexico	2007014454	TABLETA DE BOSENTAN DISPERSABLE. (DISPERSIBLE BOSERTAN TABLET.)
Canada	2607098	COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET)
Hong Kong	1120212	DISPERSIBLE BOSERTAN TABLET
European Patent Office	1883397	COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET)
Norway	20076325
Norway	339781
Cyprus	1110610

Supplementary Protection Certificates for bosentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
0526708	02C0042	France		PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
0526708	SPC/GB02/030	United Kingdom		PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
0526708	0290017-3	Sweden		PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228

Bosentan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bosentan

Introduction

Bosentan, marketed under the brand name Tracleer, is a dual endothelin receptor antagonist used primarily for the treatment of pulmonary arterial hypertension (PAH), a rare and severe condition characterized by high blood pressure in the vessels of the lungs. Here, we delve into the market dynamics and financial trajectory of bosentan, highlighting key factors, market segments, and future projections.

Market Size and Growth Projections

The global bosentan market has been experiencing steady growth, driven by the increasing prevalence of PAH and the lack of alternative treatments. As of 2022, the global Tracleer (bosentan) market was valued at several million dollars and is anticipated to reach a significantly higher value by 2029, with a compound annual growth rate (CAGR) during the forecast period of 2023-2029[1].

Regional Market Analysis

• North America: The North American market for Tracleer (bosentan) is expected to grow from a substantial figure in 2023 to a higher value by 2029, at a notable CAGR during the forecast period[1].
• Asia-Pacific: Similarly, the Asia-Pacific market is projected to increase from a significant figure in 2023 to a higher value by 2029, also at a notable CAGR[1].

Market Segmentation

The bosentan market is segmented based on several key factors:

By Type

• 62.5 mg Tablet: This dosage is one of the primary forms in which bosentan is administered.
• 125 mg Tablet: Another common dosage, often prescribed based on patient response and medical necessity.
• 32 mg Tablet for Oral Suspension: This form is particularly useful for pediatric patients or those who have difficulty swallowing tablets[1].

By Application

• Pediatric Patients: Bosentan is used to treat PAH in children, where it has shown significant benefits in improving clinical and hemodynamic status.
• Adult Patients: The majority of the market is comprised of adult patients suffering from PAH, including those with idiopathic PAH (iPAH) and PAH associated with connective tissue diseases (PAH-CTD)[1].

Key Manufacturers and Market Share

Actelion Pharmaceuticals, now part of Johnson & Johnson, is one of the primary manufacturers of bosentan. In 2022, the top three vendors in the market accounted for a significant percentage of the revenue, indicating a somewhat concentrated market[1].

Health Economic Impact

The inclusion of bosentan in public health programs has been a subject of extensive economic analysis. For instance, in Australia, the listing of bosentan on the Pharmaceutical Benefits Scheme (PBS) was based on a health economic model that assessed its cost-effectiveness. The model predicted that bosentan, when added to conventional therapy, would increase average life expectancy by 1.39 to 3.87 years over a 5- to 15-year period, with an incremental cost-effectiveness ratio of approximately AU$55,927 per life-year gained[2].

Clinical Efficacy and Safety

Clinical trials and long-term studies have demonstrated that bosentan improves exercise capacity, hemodynamics, and delays clinical worsening in patients with PAH. The survival rate at 48 weeks was estimated to be around 92%, with minimal changes in quality of life observed over the treatment period[5].

Market Drivers

• Increasing Prevalence of PAH: The growing number of patients diagnosed with PAH is a significant driver for the bosentan market.
• Lack of Alternative Treatments: Bosentan remains one of the few effective treatments for PAH, making it a crucial option for patients.
• Technological Advancements: Continuous improvements in drug formulation and delivery systems are expected to enhance patient compliance and treatment outcomes[4].

Market Restraints

• High Cost: Bosentan is a high-cost medication, which can be a barrier to access for many patients.
• Side Effects: While generally well-tolerated, bosentan can have side effects such as liver enzyme elevation, which requires regular monitoring.
• Regulatory Challenges: The approval and reimbursement processes for bosentan can be complex and vary by region, affecting market growth[4].

Regional Analysis

The bosentan market is analyzed across various regions, each with its own set of market dynamics:

• North America: This region is expected to be a significant market due to high healthcare spending and advanced healthcare infrastructure.
• Europe: Europe also represents a substantial market, with a strong focus on public health programs and reimbursement policies.
• Asia-Pacific: This region is anticipated to grow rapidly due to increasing healthcare expenditure and a large patient population[4].

Technological Trends and New Product Developments

The bosentan market is influenced by technological advancements in pharmaceutical manufacturing and drug delivery systems. Companies are focusing on improving the formulation of bosentan to enhance bioavailability and patient compliance. Additionally, there is ongoing research into new indications and combination therapies that could expand the market for bosentan[4].

Competitive Landscape

The competitive landscape of the bosentan market is characterized by a few key players, with Actelion Pharmaceuticals being the dominant force. Other companies, such as BOC Sciences and Toronto Research Chemicals, are also active in the market, focusing on expanding their product portfolios and improving their market positions[4].

COVID-19 and Other External Factors

The COVID-19 pandemic and geopolitical events like the Netherlands-Ukraine War have had an impact on the global bosentan market. These factors have affected supply chains, production, and distribution, but the market is expected to recover as these challenges are mitigated[1].

Future Projections

The global bosentan market is projected to continue growing, driven by increasing demand and the lack of effective alternative treatments. The market is expected to reach significant revenue by 2029, with a steady CAGR during the forecast period. Technological advancements and expanding public health programs are likely to further boost the market[1].

Key Takeaways

• Growing Market Size: The global bosentan market is expected to grow significantly by 2029.
• Regional Growth: North America and Asia-Pacific are key regions driving market growth.
• Clinical Efficacy: Bosentan has demonstrated significant clinical benefits in treating PAH.
• Economic Impact: The drug is cost-effective in improving patient outcomes and life expectancy.
• Technological Advancements: Ongoing improvements in drug formulation and delivery systems will enhance market growth.

FAQs

What is bosentan used for?

Bosentan is used for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the vessels of the lungs.

Who are the key manufacturers of bosentan?

Actelion Pharmaceuticals, now part of Johnson & Johnson, is one of the primary manufacturers of bosentan.

What are the common dosages of bosentan?

Bosentan is available in 62.5 mg and 125 mg tablets, as well as a 32 mg tablet for oral suspension.

How effective is bosentan in treating PAH?

Bosentan has been shown to improve exercise capacity, hemodynamics, and delay clinical worsening in patients with PAH, with a significant improvement in survival rates.

What are the potential side effects of bosentan?

Bosentan can cause side effects such as liver enzyme elevation, which requires regular monitoring, and other adverse events that may lead to treatment discontinuation.

Sources

1. Valuates Reports: Tracleer (bosentan) Market Dynamics and Key Factors That Will Drive The Market's Growth, Global Opportunity and Industry Forecast 2029.
2. Public funding of bosentan for the treatment of pulmonary artery hypertension: Health economic model assessing the cost effectiveness of bosentan.
3. MarketResearchIntellect: Global Bosentan Hydrate API Market Report.
4. Cognitive Market Research: Bosentan Market Report 2024 (Global Edition).
5. ARD BMJ: Long-term effects of bosentan on quality of life, survival, safety and clinical worsening in patients with pulmonary arterial hypertension.