Macitentan - Generic Drug Details

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

Macitentan is the generic ingredient in three branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Torrent, Zydus Lifesciences, and Actelion, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Macitentan has ninety-nine patent family members in thirty-four countries.

There are ten drug master file entries for macitentan. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for macitentan

International Patents:	99
US Patents:	5
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	57
Patent Applications:	883
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for macitentan
What excipients (inactive ingredients) are in macitentan?	macitentan excipients list
DailyMed Link:	macitentan at DailyMed

Recent Clinical Trials for macitentan

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

Sponsor	Phase
American Heart Association	Phase 4
Janssen, LP	Phase 4
Janssen Pharmaceutical K.K.	Phase 3

See all macitentan clinical trials

Generic filers with tentative approvals for MACITENTAN

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET; ORAL
		10MG	TABLET;ORAL
		10MG	TABLET;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 macitentan

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for macitentan

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

Paragraph IV (Patent) Challenges for MACITENTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPSUMIT	Tablets	macitentan	10 mg	204410	11	2017-10-18

US Patents and Regulatory Information for macitentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No			Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No

EU/EMA Drug Approvals for macitentan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Opsumit	macitentan	EMEA/H/C/002697 Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.	Authorised	no	no	yes	2013-12-20

International Patents for macitentan

Country	Patent Number	Title	Estimated Expiration
Israel	197235	תכשירים רפואיים ומוצר המכילים מרכיבים בעלי תכונות מעכבי pde5, ושימוש בהם ביצור תרופות (Therapeutic compositions and products comprising compounds having pde5-inhibitory properties and their use in the manufacture of medicaments)
South Korea	20090057009	THERAPEUTIC COMPOSITIONS
Japan	2009519893
Japan	5054061

Supplementary Protection Certificates for macitentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2059246	C02059246/01	Switzerland		PRODUCT NAME: MACITENTAN UND TADALAFIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69446 10.10.2024
1345920	300672	Netherlands		PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	C01345920/01	Switzerland		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
1345920	CR 2014 00012	Denmark		PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227

Market Dynamics and Financial Trajectory for Macitentan

Introduction to Macitentan

Macitentan, marketed under the brand name Opsumit, is an endothelin receptor antagonist used primarily in the treatment of pulmonary arterial hypertension (PAH). It is a crucial medication in managing this severe and progressive disease.

Market Size and Growth

The global macitentan market is anticipated to experience significant growth over the forecast period. As of 2023, the market was valued at several million USD and is expected to reach a substantial figure by 2030, driven by a compound annual growth rate (CAGR) that reflects the increasing demand for effective PAH treatments[4].

Key Drivers of Market Growth

Several factors are driving the growth of the macitentan market:

• Increasing Prevalence of PAH: The rising incidence of PAH, a rare but severe cardiovascular disease, is a primary driver. Early diagnosis and awareness campaigns are contributing to higher demand for treatments like macitentan[1].
• Advancements in Combination Therapies: Recent FDA approvals and ongoing clinical trials are exploring new combination therapy potentials, which are expected to enhance the therapeutic efficacy of macitentan[1].
• Aging Population: Regions with growing aging populations present a burgeoning demand for effective PAH treatments, as the disease is more prevalent among older adults[1].
• Government Initiatives and Funding: Government support and funding for rare disease research are increasing the demand for targeted therapies like macitentan[1].

Market Segmentation

The macitentan market is segmented based on several criteria:

• By Application: The primary application is in treating PAH, with a focus on adult and pediatric patients[1].
• By Distribution Channel: Macitentan tablets are distributed through hospital pharmacies, online pharmacies, and retail pharmacies, making them more accessible to patients[1].
• By Dosage Form: The medication is available in various forms, including capsules and tablets[1].
• By End User: The end users include hospitals, specialty clinics, and homecare settings[1].
• By Drug Type: The market includes both branded and generic versions of macitentan[1].

Financial Performance

Historically, macitentan has shown strong financial performance:

• Actelion's Financial Results: In 2016, sales of Opsumit (macitentan) amounted to 831 million Swiss francs, representing a 57% increase at constant exchange rates (CER) compared to 2015. This strong growth contributed to Actelion's overall revenue of CHF 2,412 million, a 15% increase at CER[5].
• Johnson & Johnson Acquisition: The significant financial interest in macitentan is highlighted by Johnson & Johnson's $30 billion proposal to acquire Actelion in 2017, which underscores the drug's market value and potential[5].

Current Market Trends

• Innovations and R&D: The market is driven by continuous innovation, with research focusing on enhancing macitentan's efficacy through genetic profiling and targeted drug delivery systems. Biotech firms are exploring partnerships for innovative R&D, particularly in personalized medicine approaches[1].
• Strategic Pricing and Reimbursement: Companies are implementing strategic pricing and reimbursement policies to boost the adoption of macitentan tablets, especially in emerging markets[1].
• Expansion of Healthcare Infrastructure: The expansion of healthcare infrastructure in emerging markets is enhancing the penetration of macitentan tablets, making them more accessible to a broader patient population[1].

Market Challenges

Despite the growth drivers, the macitentan market faces several challenges:

• High Cost and Lack of Reimbursement: The high cost of macitentan therapy and limited reimbursement options can limit its adoption. For instance, the annual cost of similar PAH treatments like Winrevair can be as high as $238,000, making affordability a significant issue[3].
• Stringent Regulatory Requirements: Strict regulatory requirements can delay product launches in some regions, affecting market growth[1].
• Competition from Alternative Therapies: The market is moderately competitive, with key players like Johnson & Johnson, Actelion, and others investing heavily in R&D. Competition from alternative therapies and generics also poses a challenge[1].

Key Players

The macitentan market is dominated by several key players:

• Actelion Pharmaceuticals Ltd (A Johnson & Johnson Company): Known for Opsumit, Actelion has been a major player in the PAH treatment market[1][5].
• Bio Crick, AbMole Bioscience, Aurum Pharmatech LLC, A2Z Chemical, eNovation Chemicals: These companies are also significant players in the macitentan market, focusing on various aspects of the drug's production and distribution[4].

Regional Market Analysis

The global macitentan market is segmented by region, with significant markets in:

• Americas: The U.S. is a major market, driven by high healthcare spending and advanced medical infrastructure[1].
• Asia-Pacific: Countries like China, India, and Japan are emerging as key markets due to growing healthcare infrastructure and increasing awareness of PAH[1].
• Europe, Middle East & Africa: This region also presents significant opportunities, with countries like Germany, France, and the UK being major contributors to the market[1].

Future Outlook

The future of the macitentan market looks promising, driven by:

• Continued Innovation: Ongoing research and development in combination therapies and personalized medicine are expected to enhance the drug's efficacy and market position[1].
• Expanding Market Access: Efforts to expand market access in emerging economies through better pricing strategies and regulatory adaptations will be crucial[1].
• Growing Demand: The increasing prevalence of PAH and the aging population will continue to drive demand for effective treatments like macitentan[1].

Key Takeaways

• The macitentan market is driven by the increasing prevalence of PAH and advancements in combination therapies.
• High costs and stringent regulatory requirements are significant challenges.
• Key players are investing heavily in R&D to maintain a competitive edge.
• Expanding healthcare infrastructure and strategic pricing are crucial for market growth.
• The market is expected to grow significantly over the forecast period, driven by increasing demand and innovation.

Frequently Asked Questions (FAQs)

Q: What is the primary use of macitentan? A: Macitentan is primarily used in the treatment of pulmonary arterial hypertension (PAH).

Q: Who are the key players in the macitentan market? A: Key players include Actelion Pharmaceuticals Ltd (A Johnson & Johnson Company), Bio Crick, AbMole Bioscience, and others.

Q: What are the main challenges facing the macitentan market? A: High costs, lack of reimbursement, stringent regulatory requirements, and competition from alternative therapies are significant challenges.

Q: How is the market segmented? A: The market is segmented by application, distribution channel, dosage form, end user, drug type, and region.

Q: What is the expected growth rate of the macitentan market? A: The market is anticipated to grow at a significant CAGR over the forecast period, driven by increasing demand and innovation.

Cited Sources

1. 360iResearch: Macitentan Tablets Market Size & Share 2025-2030
2. Johnson & Johnson: 2023 Second-Quarter Financial Results
3. iHealthcareAnalyst: Global Pulmonary Arterial Hypertension Market
4. Valuates Reports: Global Macitentan Market Research Report 2024
5. GlobeNewswire: Actelion Announces Excellent Financial Results for 2016

Last updated: 2024-12-16