LETAIRIS Drug Patent Profile

When do Letairis patents expire, and when can generic versions of Letairis launch?

Letairis is a drug marketed by Gilead and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Letairis

A generic version of LETAIRIS was approved as ambrisentan by MYLAN on March 28^th, 2019.

Summary for LETAIRIS

International Patents:	51
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	23
Patent Applications:	2,700
Drug Prices:	Drug price information for LETAIRIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LETAIRIS
What excipients (inactive ingredients) are in LETAIRIS?	LETAIRIS excipients list
DailyMed Link:	LETAIRIS at DailyMed

See drug prices for LETAIRIS

Recent Clinical Trials for LETAIRIS

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

Sponsor	Phase
Medical University of South Carolina	Phase 4
Ochsner Health System	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all LETAIRIS clinical trials

Pharmacology for LETAIRIS

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Paragraph IV (Patent) Challenges for LETAIRIS

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 LETAIRIS

LETAIRIS is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	9,474,752
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes	9,474,752
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	8,377,933
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	9,549,926
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes	8,377,933

Expired US Patents for LETAIRIS

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 LETAIRIS

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 LETAIRIS

When does loss-of-exclusivity occur for LETAIRIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Luxembourg

Poland

Portugal

Slovenia

Spain

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 LETAIRIS around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2101777
World Intellectual Property Organization (WIPO)	2012051559
Japan	2012111772	NEW CARBOXYLIC ACID DERIVATIVE, AND PREPARATION AND USE THEREOF
Canada	2814518	COMPOSITIONS ET METHODES DE TRAITEMENT DE L'HYPERTENSION ARTERIELLE PULMONAIRE (COMPOSITIONS AND METHODS OF TREATING PULMONARY HYPERTENSION)
Czech Republic	9701132

Supplementary Protection Certificates for LETAIRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	2016C/032	Belgium		PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
0785926	SPC029/2008	Ireland		SPC029/2008: 20091119, EXPIRES: 20201006
2101777	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0785926	08C0041	France		PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
0785926	CA 2008 00037	Denmark

LETAIRIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Letairis (Ambrisentan)

Overview of Letairis

Letairis, also known as ambrisentan, is a medication used to treat pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. It belongs to the class of endothelin receptor antagonists (ERAs) and is administered orally[1][3][4].

Market Position and Competition

Letairis has been a significant player in the PAH market, although it has not surpassed the peak sales of its competitor, Tracleer (bosentan) by Johnson & Johnson. Despite this, Letairis remains a market-leading drug due to its efficacy and the increasing adoption of ERAs in combination with phosphodiesterase 5 (PDE5) inhibitors, as evidenced by the AMBITION trial[3].

Generic Competition

The market dynamics for Letairis have been significantly impacted by the introduction of generic versions. In October 2018, Letairis faced generic competition in the U.S., followed by other markets. This competition has led to a decline in sales for the branded version of Letairis. For instance, Teva Pharmaceutical Industries launched a generic version of Letairis in the U.S. in 2019, which has been a crucial addition to Teva’s extensive portfolio of generic medicines[1][3].

Financial Impact of Generic Competition

The launch of generic versions has resulted in a substantial decline in sales for the branded Letairis. According to Gilead Sciences' financial reports, the sales of Letairis decreased significantly after generic entries in the first half of 2019. This decline was part of a broader trend where other product sales, including Letairis and Ranexa, decreased by 18% for the full year 2020 compared to the previous year[2].

Market Size and Growth

The global PAH market, within which Letairis operates, was valued at USD 7.66 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 5.4% from 2024 to 2030. This growth is driven by increasing support from government and healthcare authorities for new drug development, rising prevalence of PAH, and favorable reimbursement policies[4].

Segment Analysis

Branded vs. Generic

The PAH market is segmented into branded and generic types. The branded segment, which includes Letairis, held the largest share of the market in 2023 due to strong pipelines and heavy investments by market players. However, the generic segment is expected to register the fastest CAGR during the forecast period due to factors such as cost, patent expiry, and availability of generics[4].

Route of Administration

The oral segment, which includes Letairis, held the largest share in the PAH market in 2023. This is attributed to the growing availability of oral formulations and patient preference for oral administration. The approval of new oral formulations is expected to continue driving growth in this segment[4].

Financial Performance

Revenue Trends

Letairis had significant annual sales before facing generic competition. For example, as of February 2019, Letairis had annual sales of nearly $247 million in the U.S.[1].

Impact on Parent Companies

For Gilead Sciences, the decline in Letairis sales was partially offset by the growth in sales of other products, such as Veklury (remdesivir) and Biktarvy. However, the overall impact of generic competition on Letairis has been a reduction in revenue from this product line[2].

Future Outlook

Despite the challenges posed by generic competition, Letairis is expected to maintain a steady presence in the market. The increasing adoption of ERAs in combination with PDE5 inhibitors will help counterbalance some of the generic erosion. Additionally, ongoing research and development activities in the field of PAH are likely to introduce new treatment options and potentially impact the market share of existing drugs like Letairis[3][4].

Key Players and Market Dynamics

The PAH market is highly competitive, with key players including United Therapeutics Corporation, Bayer, Gilead Sciences, Johnson & Johnson, Viatris Inc., GlaxoSmithKline, and Teva Pharmaceuticals Inc. These companies are involved in various strategies such as product launches, generic entries, and research collaborations to maintain their market positions[4].

Conclusion

Letairis, while facing significant challenges from generic competition, remains an important drug in the treatment of PAH. The financial trajectory of Letairis has been impacted by the introduction of generic versions, leading to a decline in sales. However, the overall PAH market is expected to grow, driven by increasing support for new drug development and favorable reimbursement policies.

Key Takeaways

• Letairis is an endothelin receptor antagonist used to treat PAH.
• The drug faced generic competition in the U.S. in 2018, leading to a decline in sales.
• The global PAH market is growing, driven by new drug developments and favorable reimbursement policies.
• The branded segment, including Letairis, is expected to face increasing competition from generics.
• Oral formulations, such as Letairis, remain preferred due to patient convenience.

FAQs

Q1: What is Letairis used for?

Letairis (ambrisentan) is used to treat pulmonary arterial hypertension (PAH) to improve exercise ability and delay clinical worsening.

Q2: What is the impact of generic competition on Letairis sales?

The introduction of generic versions of Letairis has led to a significant decline in sales for the branded version, as seen in the financial reports of Gilead Sciences.

Q3: How is the PAH market expected to grow?

The global PAH market is expected to grow at a CAGR of 5.4% from 2024 to 2030, driven by new drug developments, rising prevalence of PAH, and favorable reimbursement policies.

Q4: Which segment is expected to grow the fastest in the PAH market?

The generic segment is expected to register the fastest CAGR during the forecast period due to factors such as cost, patent expiry, and availability of generics.

Q5: What are the key drivers of the PAH market?

Key drivers include increasing support from government and healthcare authorities, rising prevalence of PAH, favorable reimbursement policies, and substantial research and development activities.

Sources

1. Teva Pharmaceutical Industries Ltd. - "Teva Announces Launch of a Generic Version of Letairis® (ambrisentan) Tablets in the United States" - May 1, 2019.
2. Gilead Sciences - "Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results" - February 4, 2021.
3. GlobeNewswire - "Global Letairis (ambrisentan; Gilead/GlaxoSmithKline) Markets 2016-2017-2018-2025" - June 27, 2019.
4. Grand View Research - "Pulmonary Arterial Hypertension Market Size Report, 2030" - Accessed December 17, 2024.