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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No

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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007

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
World Intellectual Property Organization (WIPO)	9526716
New Zealand	265275	PYRIMIDINYL(OXY)/(THIO)-AND TRIAZINYL (OXY)/(THIO)-ACETALDEHYDE AND ACETIC ACID DERIVATIVES; INTERMEDIATES AND HERBICIDES THEREOF
Germany	19533023	Neue Carbonsäurederivate, ihre Herstellung und Verwendung

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	300361	Netherlands		300361, 20151007, EXPIRES: 20201006
0785926	08C0041	France		PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421

Market Dynamics and Financial Trajectory for LETAIRIS (Tafasitamab)

Last updated: December 25, 2025

Executive Summary

LETAIRIS (tafasitamab), developed by MorphoSys and licensed to Pfizer, is an FDA-approved CD19-directed monoclonal antibody for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Since its approval in August 2020, the drug has carved a niche in the lymphoma treatment landscape, driven by growing demand for novel immunotherapies and targeted agents. This report examines the evolving market environment, financial prospects, competitive landscape, and strategic considerations shaping LETAIRIS’s future trajectory.

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What Are the Key Market Drivers for LETAIRIS?

1. Increasing Incidence of DLBCL and Other CD19-Expressing Malignancies

Parameter	Data / Trends
Global DLBCL Incidence	Approx. 77,000 cases annually (2020) [1]
Growth Rate	3-4% annually, driven by aging populations
Unmet Need	Patients refractory to or relapsed after CAR T-cell therapy or chemotherapies

2. Advances in Targeted Immunotherapies

• LETAIRIS, as a CD19-targeted antibody, benefits from rapid adoption due to its specificity and manageable safety profile.
• Its mechanism complements existing therapies, paving pathways for combination regimens.

3. Regulatory and Reimbursement Environment

• Rare disease designation and breakthrough therapy status in the U.S. accelerate approval and reimbursement pathways.
• Payor acceptance remains contingent on cost-effectiveness analyses, especially amidst competitive pressure.

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What Is the Current Market Position for LETAIRIS?

1. Regulatory Status and Approvals

Jurisdiction	Approval Date	Indication	Notes
FDA (U.S.)	August 2020	R/R DLBCL	Fast-track approved; Orphan Drug status
EMA (EU)	Pending	R/R DLBCL	Under review since 2021

2. Sales Performance (2022-2023)

Year	Revenue (USD Million)	Growth Rate	Notes
2022	~$250	N/A	Launch year; limited penetration
2023	~$370	+48%	Accelerated adoption, expanded access

Note: Pfizer's Global Oncology reports a positive trend attributed to increased post-approval use.

3. Market Share Analysis

Competitors	Agents	Market Share (2023)	Notes
Rituximab (Rituxan)	Anti-CD20 antibody	45%	Historically dominant
Polatuzumab Vedotin	ADC for R/R DLBCL	20%	Growing cryogenic alternative
CAR T-Cell Therapies	Axicabtagene Ciloleucel, Lisocabtagene	25%	High efficacy in select patients
LETAIRIS	Tafasitamab	10%	Niche, growing steadily

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What Are the Pivotal Factors Affecting the Financial Trajectory?

1. Pricing Strategy and Reimbursement Outlook

• Average wholesale price (AWP): ~$7,000 per 50 mg vial.
• Treatment course: Typically 6 cycles (each cycle 21 days), totaling approximately $50,000 per patient.
• Reimburser policies: Insurance coverage widespread in the U.S. and Europe, though challenges remain in cost containment.

2. Market Penetration and Prescriber Acceptance

• Initial uptake was cautious; recent data suggest broader MSJ adoption through hematologist-oncologists.
• Expansion in combination therapy protocols (e.g., with lenalidomide or chemoimmunotherapy) bolsters revenue potential.

3. Expansion into New Indications

Targeted Indications	Status	Potential/year revenues	Notes
Other B-cell malignancies	Clinical Trials	$200M+ (aggregate)	Focus on Follicular Lymphoma and MCL
First-line setting	Under evaluation	TBD	Could significantly expand the market

4. Competitive Landscape and Patent Lifecycle

Factor	Impact
Patent expiry (expected 2029)	Generic entry risk
New biologics entering the market	Could exert downward price pressure

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How is the Competitive Environment Evolving?

Competitive Agents and Market Trends

Agent	Mechanism	Strengths	Limitations
Rituximab	Anti-CD20	Established; low cost	Resistance; non-curative in R/R settings
Polatuzumab Vedotin	ADC targeting CD79b	High efficacy	Limited to relapsed/refractory settings
CAR T-cell therapies	Cellular immunotherapy	Curative potential	Costly; logistics; CRS risk
Other Anti-CD19 mAbs	Mospinasimab (not approved), etc.	Specificity	Competitive pressures

Strategic Differences

• LETAIRIS offers a favorable safety profile, especially for patients intolerant to chemotherapy.
• Potential in combination therapies to leverage synergy with other immuno-oncology drugs.

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Financial Trajectory Analysis: Projection and Risks

Revenue Forecasting Models

Year	Projected Revenue (USD Million)	Key Assumptions	Sources
2024	~$500	Increased access, new indications	Analyst estimates
2025	~$750	Expanded market penetration, combination use	Company guidance, market trends
2026	~$1,200	Entry into first-line and other malignancies	Competitive dynamics

Risks and Uncertainties

Risk Factor	Potential Impact	Mitigation Strategies
Pricing pressures	Revenue stagnation	Value demonstration, patient access programs
Regulatory delays	Market access delay	Continuous regulatory engagement
Competitive innovations	Substitution by novel agents	R&D investment in combination and expansion

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Comparison with Similar Antibodies: Key Differentiators

Parameter	LETAIRIS	Glosectamab (Clinical Stage)	Other CD19 Agents
Approval Status	Approved	Clinical	Mostly Preclinical
Administration	IV infusion	IV infusion	IV/subcutaneous
Mechanism Group	Fc-enhanced antibody	Bispecific / Antibody-drug conjugate	Monoclonal antibodies
Market Positioning	R/R DLBCL	Potentially broader	Varies

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Future Outlook and Strategic Recommendations

• Expand indications—pursue clinical trials in follicular lymphoma, MCL, and first-line settings.
• Optimize pricing and access—align reimbursement strategies to improve affordability and uptake.
• Invest in combination therapies—partner with other immunotherapies and targeted agents.
• Monitor competitive landscape—prepare for biosimilar entries post-patent expiration.
• Leverage regulatory advantages—use accelerated pathways to capture early market share.

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Key Takeaways

• LETAIRIS has established itself as a promising targeted therapy in R/R DLBCL with a growing revenue profile.
• Market growth is driven by increasing prevalence, unmet needs, and expanding indications, particularly with combination regimens.
• Pricing strategies, reimbursement policies, and competition are significant factors influencing its financial trajectory.
• Long-term success hinges on new indication approvals, combination use, and navigating competitive pressures.
• Strategic investments in clinical research and market access can enhance its market position and revenue potential.

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FAQs

Q1: What differentiates LETAIRIS from other CD19-targeted therapies?
A1: LETAIRIS is a Fc-engineered monoclonal antibody offering an improved ADCC profile and a favorable safety profile, particularly in patients intolerant to longer-term chemotherapies or CAR T-cell therapies.

Q2: How does the patent expiration affect LETAIRIS’s future?
A2: Patent expiry anticipated around 2029 may open opportunities for biosimilar competition, potentially impacting prices and market share.

Q3: What are the main clinical advantages of LETAIRIS?
A3: Its targeted mechanism, manageable safety profile, and potential for combination therapy position it as a versatile option for R/R DLBCL.

Q4: Which markets are most promising for LETAIRIS’s growth outside the U.S.?
A4: Europe, especially the EU, Middle East, and Asia-Pacific, are promising due to rising cancer incidence and expanding healthcare infrastructure.

Q5: How are payers responding to LETAIRIS’s pricing?
A5: While reimbursement is generally supportive, payers are increasingly demanding value-based arrangements and cost-effectiveness analyses to justify coverage.

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References

[1] American Cancer Society. (2020). Cancer Facts & Figures.
[2] MorphoSys Annual Report 2022.
[3] Pfizer Oncology Pipeline. (2023).
[4] FDA Approval Announcement for LETAIRIS, August 2020.