AMBRISENTAN - Generic Drug Details

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

Ambrisentan is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Cipla, Endo Operations, Mylan, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Gilead, and is included in ten NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ambrisentan has fifty-one patent family members in twenty-six countries.

There are nine drug master file entries for ambrisentan. Eleven suppliers are listed for this compound.

Summary for AMBRISENTAN

International Patents:	51
US Patents:	3
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	65
Patent Applications:	4,108
Drug Prices:	Drug price trends for AMBRISENTAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMBRISENTAN
What excipients (inactive ingredients) are in AMBRISENTAN?	AMBRISENTAN excipients list
DailyMed Link:	AMBRISENTAN at DailyMed

See drug prices for AMBRISENTAN

Recent Clinical Trials for AMBRISENTAN

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

Sponsor	Phase
Lexicon Pharmaceuticals	Phase 2
Juvenile Diabetes Research Foundation	Phase 2
University Medical Center Groningen	Phase 2

See all AMBRISENTAN clinical trials

Pharmacology for AMBRISENTAN

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for AMBRISENTAN

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

Paragraph IV (Patent) Challenges for AMBRISENTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LETAIRIS	Tablets	ambrisentan	5 mg and 10 mg	022081	1	2015-02-09

US Patents and Regulatory Information for AMBRISENTAN

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	AMBRISENTAN	ambrisentan	TABLET;ORAL	208252-001	Mar 28, 2019	AB	RX	No	No
Sun Pharm	AMBRISENTAN	ambrisentan	TABLET;ORAL	210784-002	Mar 28, 2019	AB	RX	No	No
Aurobindo Pharma	AMBRISENTAN	ambrisentan	TABLET;ORAL	216531-002	Jul 21, 2022	AB	RX	No	No
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	9,549,926
Sun Pharm	AMBRISENTAN	ambrisentan	TABLET;ORAL	210784-001	Mar 28, 2019	AB	RX	No	No

Expired US Patents for AMBRISENTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	5,932,730
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	5,703,017
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	7,109,205
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	7,601,730
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	5,703,017

EU/EMA Drug Approvals for AMBRISENTAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Volibris	ambrisentan	EMEA/H/C/000839 Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).	Authorised	no	no	no	2008-04-20
Mylan S.A.S	Ambrisentan Mylan	ambrisentan	EMEA/H/C/004985 Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.	Authorised	yes	no	no	2019-06-20

International Patents for AMBRISENTAN

Country	Patent Number	Title	Estimated Expiration
Hungary	S1600027
New Zealand	610012	Compositions and methods of treating pulmonary hypertension
Japan	5806320
Mexico	2013004190	COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA HIPERTENSION PULMONAR. (COMPOSITIONS AND METHODS OF TREATING PULMONARY HYPERTENSION.)
Hungary	E025355

Supplementary Protection Certificates for AMBRISENTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	PA2016018	Lithuania		PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0785926	08C0041	France		PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
2101777	C20160017 00199	Estonia		PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2101777	2016C/032	Belgium		PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125

AMBRISENTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ambrisentan

Market Overview

The Ambrisentan drug market is experiencing significant growth, driven by increasing demand for effective treatments for Pulmonary Arterial Hypertension (PAH). This market is fueled by several key factors, including an aging global population, improved diagnostic methods, and rising awareness of PAH[3].

Global Market Size and Growth

The global Ambrisentan market is projected to grow at a Compound Annual Growth Rate (CAGR) of 7-9% over the next several years. This growth is attributed to the increasing incidence of PAH worldwide and the drug's superior efficacy and safety profile. In the U.S., the Ambrisentan market is valued at approximately $300 million in 2023, with an expected annual growth rate of 8%[1][3].

Regional Market Analysis

United States

The U.S. market for Ambrisentan is substantial, driven by the healthcare system's focus on specialized therapies and increasing patient access to treatments. Key players such as Gilead Sciences and Janssen Biotech dominate the market. Emerging trends include the development of combination therapies and the use of telehealth for patient management[1].

Asia-Pacific

In this region, countries like China, Japan, and India are seeing significant growth. For example, in Malaysia, the Ambrisentan market is valued at around $18 million with a growth rate of 6% annually. Gilead Sciences leads the market, and government health policies are enhancing patient access to essential medications[1].

Latin America

Countries in Latin America, such as Mexico and Brazil, are also experiencing growth. In Mexico, the Ambrisentan market is valued at around $30 million with a growth rate of 10%. In Brazil, the market is approximately $60 million with an expected growth rate of 8%. Key players include Gilead Sciences and local manufacturers[1].

Middle East & Africa

In this region, countries like Turkey and the UAE are showing promising growth. Turkey's Ambrisentan market is valued at approximately $25 million with a growth rate of 9%, while the UAE's market is valued at around $15 million with a projected growth rate of 10%[1].

Factors Driving Market Growth

Increasing Awareness and Diagnosis

Improved diagnostic methods and increased awareness of PAH are leading to higher patient identification and treatment rates. Advancements in genetic testing and screening have made it easier to diagnose PAH in its early stages, contributing to the growing demand for Ambrisentan[3].

Aging Population

The global aging population is a significant factor driving the demand for PAH treatments. As people age, the incidence of diseases associated with pulmonary vascular dysfunction increases, leading to a higher demand for targeted therapies like Ambrisentan[1][3].

Healthcare Policies and Infrastructure

Government healthcare policies aimed at improving chronic disease management and expanding healthcare infrastructure in emerging economies are boosting access to life-saving drugs like Ambrisentan. This is particularly evident in regions such as Asia-Pacific, Latin America, and the Middle East & Africa[1][3].

Challenges and Limitations

Regulatory Approvals

Stringent regulatory approvals can hinder the growth of the Ambrisentan market. The process of obtaining approvals is often lengthy and costly, which can delay market entry and impact revenue[1].

High Treatment Costs

The high cost of Ambrisentan treatment is a significant barrier to patient access. This can limit market potential, especially in regions with lower healthcare spending. For instance, the expected annual cost per patient receiving Ambrisentan is estimated to be around $16,055[2][4].

Competition from Alternatives

Competition from alternative therapies and generics can also impact the market. Studies have shown that in some cases, alternatives like bosentan or sildenafil may be more cost-effective, which could influence treatment choices[2][4].

Cost-Utility and Economic Evaluation

Economic evaluations have shown mixed results regarding the cost-effectiveness of Ambrisentan compared to other treatments. For example, a study in Colombia found that Ambrisentan was not cost-effective compared to bosentan or sildenafil for treating pediatric PAH patients. The study estimated higher costs and similar quality-adjusted life-years (QALYs) for Ambrisentan[2][4].

Emerging Trends and Innovations

Combination Therapies

Ambrisentan is increasingly being incorporated into combination therapies, where it is paired with other treatments like sildenafil or riociguat. This multi-drug approach enhances its effectiveness and makes it a vital part of personalized treatment plans[3].

Digital Health Solutions

The adoption of digital health solutions and telemedicine is presenting promising opportunities for market expansion. These innovations facilitate better patient management and improve access to medications, especially in underserved populations[1][3].

Research and Development

Pharmaceutical companies are investing in research to explore Ambrisentan's potential for treating other pulmonary disorders and to improve its efficacy, safety, and dosing convenience. This includes exploring new therapeutic applications and extended-release formulations[3].

Strategic Partnerships and Market Penetration

To maintain a competitive edge, pharmaceutical companies involved in the production of Ambrisentan are focusing on strategic partnerships, mergers, and acquisitions. These collaborations allow for the expansion of distribution channels, greater market penetration, and access to new markets. Partnerships with local healthcare providers and public health systems are also crucial for improving treatment distribution and awareness[3].

Key Players and Market Share

Key players in the Ambrisentan market include Gilead Sciences and Janssen Biotech. These companies hold substantial market shares and are investing in marketing strategies and collaborations to enhance their market position. Local manufacturers and distributors also play a significant role in various regions[1].

Financial Trajectory

The financial trajectory of the Ambrisentan market is optimistic, with a projected robust CAGR of 4.50% during the forecast period. The market is expected to exhibit significant growth driven by innovative drug developments, expanding patient access, and increasing healthcare spending in emerging economies. However, the market must navigate challenges such as high treatment costs, stringent regulatory approvals, and competition from alternative therapies[1][3].

Key Takeaways

• The Ambrisentan market is growing significantly due to increasing demand for PAH treatments.
• Regional markets, especially in the U.S., Asia-Pacific, Latin America, and the Middle East & Africa, are showing promising growth.
• Factors such as aging population, improved diagnostics, and healthcare policies are driving market growth.
• Challenges include high treatment costs, regulatory hurdles, and competition from alternatives.
• Emerging trends in combination therapies, digital health solutions, and R&D are shaping the market.
• Strategic partnerships are crucial for market penetration and expansion.

FAQs

Q: What is the current market size of Ambrisentan in the U.S.?

A: The Ambrisentan market in the U.S. is valued at approximately $300 million in 2023[1].

Q: What is the expected growth rate of the Ambrisentan market globally?

A: The global Ambrisentan market is expected to grow at a CAGR of 7-9% over the next several years[3].

Q: What are the main factors driving the growth of the Ambrisentan market?

A: The main factors include an aging population, improved diagnostic methods, increasing awareness of PAH, and advancements in healthcare infrastructure[1][3].

Q: How does Ambrisentan compare to other PAH treatments in terms of cost-effectiveness?

A: Studies have shown that Ambrisentan may not be as cost-effective as alternatives like bosentan or sildenafil in some cases, particularly in pediatric patients[2][4].

Q: What are the emerging trends in the Ambrisentan market?

A: Emerging trends include the use of combination therapies, digital health solutions, and ongoing research to improve the drug's efficacy and safety[3].

Sources

1. Global Ambrisentan Drug Market Share Analysis - Industry Trends. OpenPR.
2. Cost-utility of ambrisentan and bosentan for pediatric pulmonary arterial hypertension. PubMed.
3. Ambrisentan Drug Market Size And Projection. Market Research Intellect.
4. Ambrisentan for in pediatric pulmonary arterial hypertension: A cost‐utility analysis. Wiley Online Library.