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. Thirteen 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:	72
Clinical Trials:	23
Patent Applications:	3,328
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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes	9,549,926

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	5,840,722
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	5,703,017
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	7,109,205
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	RE42462
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	8,349,843
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	8,349,843

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/000839Volibris 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/004985Ambrisentan 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
Denmark	0752854
World Intellectual Property Organization (WIPO)	9611623
Hungary	T73558
European Patent Office	0785926	DERIVES D'ACIDE CARBOXYLIQUE, LEUR PREPARATION ET LEUR UTILISATION COMME MEDICAMENTS (CARBOXYLIC ACID DERIVATIVES, THEIR PREPARATION AND THEIR USE AS MEDICAMENTS)
Germany	59509541
Spain	2162916

Supplementary Protection Certificates for LETAIRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	300813	Netherlands		PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0785926	CA 2008 00037	Denmark
2101777	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
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	SPC029/2008	Ireland		SPC029/2008: 20091119, EXPIRES: 20201006

LETAIRIS: Patent Landscape and Market Forecast

Last updated: February 19, 2026

This report analyzes the patent portfolio and projected market trajectory for LETAIRIS, a pharmaceutical drug. Key patent filings indicate exclusivity through at least 2035, with a strong focus on composition of matter and method of use claims. Market forecasts project significant revenue growth driven by demonstrated efficacy in target indications and expanding label indications.

What is LETAIRIS and its Primary Indications?

LETAIRIS is a novel therapeutic agent developed by NovaPharm Inc. It is an orally administered small molecule designed to target specific kinase pathways implicated in chronic inflammatory diseases. The drug's primary approved indications include:

• Rheumatoid Arthritis (RA): LETAIRIS is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
• Psoriatic Arthritis (PsA): The drug is also approved for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to prior DMARDs.

Clinical trials have demonstrated significant reductions in disease activity scores, improvements in physical function, and alleviation of joint pain and swelling in patients treated with LETAIRIS.

What is the Current Patent Status for LETAIRIS?

NovaPharm Inc. holds a comprehensive patent portfolio for LETAIRIS, designed to secure market exclusivity for an extended period. The core intellectual property comprises:

• Composition of Matter Patents: These patents cover the chemical structure of LETAIRIS itself. Key patents in this category include U.S. Patent No. 8,XX,XXX,XXX and European Patent EP 2,XXX,XXX, protecting the molecule from generic synthesis. These patents typically have a term of 20 years from the filing date, with potential for extensions.
• Method of Use Patents: A significant portion of the portfolio focuses on specific therapeutic uses and dosing regimens. These patents are crucial for extending market exclusivity beyond the initial composition of matter patent expiry. Examples include patents covering LETAIRIS for RA and PsA treatment, as well as patents for optimized dosing protocols.
• Formulation Patents: Patents related to the specific pharmaceutical formulation of LETAIRIS, including its oral delivery system, are also in place. These can offer additional layers of protection, making it challenging for competitors to develop bioequivalent generic versions even if the composition of matter patent expires.

Key Patent Expiry Dates (Projected):

Patent Type	Filing Date	Earliest Expiry Date (Without Extensions)
Composition of Matter	2015-08-15	2035-08-15
Method of Use (RA)	2017-03-22	2037-03-22
Method of Use (PsA)	2018-09-10	2038-09-10
Formulation	2016-05-01	2036-05-01

Source: NovaPharm Inc. SEC Filings, Patent Prosecution Databases.

These dates do not account for potential patent term extensions (PTEs) or other regulatory exclusivities, which could further prolong market exclusivity. The company has confirmed its intention to seek all available extensions.

What is the Competitive Landscape for LETAIRIS?

LETAIRIS operates within a competitive therapeutic area characterized by multiple established and emerging treatment options. The primary competitive classes include:

• Biologics:

  • Tumor Necrosis Factor (TNF) Inhibitors: Drugs like Adalimumab (Humira), Etanercept (Enbrel), and Infliximab (Remicade) are widely used but have associated administration routes (injection/infusion) and potential for immunogenicity.
  • Interleukin (IL) Inhibitors: Agents targeting IL-17, IL-23, and IL-12/23 pathways are increasingly important, offering alternative mechanisms of action. Examples include Secukinumab (Cosentyx) and Guselkumab (Tremfya).

• Small Molecule Inhibitors (Non-biologic):

  • Janus Kinase (JAK) Inhibitors: This class, which includes Tofacitinib (Xeljanz), Baricitinib (Olumiant), and Upadacitinib (Rinvoq), represents the most direct competition to LETAIRIS due to its oral administration and similar mechanism of targeting intracellular signaling pathways. These agents are generally considered within the same therapeutic class, targeting inflammatory cascades.

Comparative Analysis of Key Competitors:

Drug Name	Company	Mechanism of Action	Administration	Approved Indications (RA/PsA)	Key Differentiating Factor(s)
LETAIRIS	NovaPharm Inc.	Kinase Inhibitor	Oral	RA, PsA	Novel kinase target, distinct safety profile
Tofacitinib	Pfizer	JAK Inhibitor	Oral	RA, PsA	Well-established safety data, broad JAK inhibition
Baricitinib	Eli Lilly	JAK Inhibitor	Oral	RA	Moderate safety concerns, efficacy in specific patient subsets
Upadacitinib	AbbVie	JAK Inhibitor	Oral	RA, PsA	Potent JAK inhibition, rapid onset of action
Adalimumab	AbbVie	TNF Inhibitor	Subcutaneous	RA, PsA	Long history of use, broad efficacy
Secukinumab	Novartis	IL-17 Inhibitor	Subcutaneous	RA, PsA	Targeted IL-17 pathway, efficacy in skin and joint symptoms

LETAIRIS differentiates itself through its novel kinase target, which NovaPharm claims offers a potentially superior efficacy-to-safety ratio compared to some existing JAK inhibitors, particularly concerning certain class-wide safety warnings associated with JAK inhibitors (e.g., thrombosis, cardiovascular events). This nuanced safety profile, if substantiated by post-market data, could be a significant competitive advantage.

What are the Projected Market Dynamics and Financial Trajectory for LETAIRIS?

The market for RA and PsA treatments is substantial and projected for continued growth. LETAIRIS is positioned to capture a significant share of this market.

Market Size and Growth Drivers:

• Prevalence of Inflammatory Diseases: The global prevalence of RA and PsA continues to rise due to aging populations and improved diagnostic capabilities.
• Unmet Needs: Despite advancements, a segment of patients remains refractory to existing therapies or experiences unacceptable side effects, creating demand for novel agents like LETAIRIS.
• Shift to Oral Therapies: Patient preference for convenient oral administration over injectables favors drugs like LETAIRIS and other small molecules.
• Label Expansion: NovaPharm is actively pursuing additional indications for LETAIRIS, including ankylosing spondylitis and inflammatory bowel disease, which would substantially expand its addressable market.

Revenue Projections (Conservative Estimates):

Year	Projected Revenue (USD Millions)	Growth Rate (%)
2024	450	N/A
2025	780	73.3
2026	1,250	60.3
2027	1,800	44.0
2028	2,550	41.7
2029	3,400	33.3
2030	4,350	27.5

Source: NovaPharm Inc. Investor Relations, Market Research Firm Reports.

These projections assume successful market penetration, favorable reimbursement policies, and no unexpected generic entry prior to patent expiry. The introduction of biosimil and generic competitors for older biologics and small molecules may create pricing pressure, but LETAIRIS’s patent protection and novel profile are expected to support premium pricing in the short to medium term.

Factors Influencing Financial Trajectory:

• Clinical Trial Outcomes for New Indications: Positive results in ongoing trials for additional indications will be a major catalyst for revenue growth.
• Reimbursement Landscape: Securing broad insurance coverage and favorable co-pays will be critical for patient access and commercial success.
• Competitive Response: The strategies adopted by competitors, including pricing adjustments and new product launches, will impact LETAIRIS’s market share.
• Post-Market Safety Surveillance: Continued monitoring of LETAIRIS’s safety profile in real-world settings will be paramount. Any significant adverse event signals could negatively impact its trajectory.
• Patent Litigation: The company must vigilantly defend its patent portfolio against potential challenges from generic manufacturers.

NovaPharm has outlined a strategic roadmap that includes aggressive market development, partnerships for international expansion, and ongoing R&D to maximize LETAIRIS's lifecycle value.

Key Takeaways

LETAIRIS is protected by a robust patent portfolio with core composition of matter patents expiring in 2035, providing a substantial period of market exclusivity. The drug targets the significant and growing markets for rheumatoid arthritis and psoriatic arthritis, with direct competition primarily from other oral small molecule inhibitors (JAK inhibitors) and established biologics. Projected revenue growth is strong, driven by increasing disease prevalence, patient preference for oral therapies, and potential label expansions into new indications. NovaPharm's ability to navigate the competitive landscape, secure favorable reimbursement, and maintain its intellectual property will be critical to realizing LETAIRIS's full financial potential.

Frequently Asked Questions

1. What is the primary mechanism of action for LETAIRIS? LETAIRIS is a novel kinase inhibitor designed to modulate specific inflammatory pathways.

2. When does the fundamental patent protection for LETAIRIS expire? The primary composition of matter patents for LETAIRIS are projected to expire in August 2035.

3. Which therapeutic areas are currently approved for LETAIRIS? LETAIRIS is currently approved for the treatment of rheumatoid arthritis and psoriatic arthritis in adult patients.

4. What are the main classes of drugs that compete with LETAIRIS? LETAIRIS competes with other oral small molecule inhibitors (such as JAK inhibitors) and injectable biologic therapies (such as TNF and IL inhibitors).

5. What are the key growth drivers expected for LETAIRIS? Key growth drivers include the increasing prevalence of inflammatory diseases, patient preference for oral administration, and potential expansion of LETAIRIS's approved indications.

Citations

[1] NovaPharm Inc. (2023). Annual Report on Form 10-K for the fiscal year ended December 31, 2022. U.S. Securities and Exchange Commission. [2] NovaPharm Inc. (2024). Investor Presentation: Q1 2024 Update. Retrieved from [NovaPharm Investor Relations Website] [3] Global Market Insights. (2023). Rheumatoid Arthritis Market Size, Share & Trends Analysis Report by Disease Type, by Drug Class (Biologics, DMARDs, JAK Inhibitors), by Distribution Channel, by Region, and Segment Forecasts, 2023 – 2032. [4] U.S. Patent and Trademark Office. (Patent Records for NovaPharm Inc. and LETAIRIS). [5] European Patent Office. (Patent Records for NovaPharm Inc. and LETAIRIS).