PROLENSA Drug Patent Profile

Which patents cover Prolensa, and when can generic versions of Prolensa launch?

Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in PROLENSA is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prolensa

A generic version of PROLENSA was approved as bromfenac sodium by SENTISS on January 22^nd, 2014.

Summary for PROLENSA

International Patents:	14
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROLENSA

Paragraph IV (Patent) Challenges for PROLENSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROLENSA	Ophthalmic Solution	bromfenac sodium	0.07%	203168	1	2013-07-26

US Patents and Regulatory Information for PROLENSA

PROLENSA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes			Y

International Patents for PROLENSA

See the table below for patents covering PROLENSA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013055856
China	100341498
Lithuania	2765988
Japan	4500261
Mexico	348418	COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.)
South Korea	20050092691	AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID
Portugal	2765988

Supplementary Protection Certificates for PROLENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
1586316	132011901975261	Italy		PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	1190018-0	Sweden		RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	C300494	Netherlands		PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	C 2011 004	Romania		PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1586316	2011C/027	Belgium		PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523

Investment Scenario, Market Dynamics, and Financial Trajectory for PROLENSA (Macitentan)

Last updated: February 3, 2026

Executive Summary

PROLENSA (macitentan) is an endothelin receptor antagonist indicated primarily for the treatment of pulmonary arterial hypertension (PAH). Since its FDA approval in 2013 by Actelion Pharmaceuticals (a Johnson & Johnson subsidiary), it has gained a notable market position. The drug's growth trajectory reflects expansion in PAH treatment paradigms, competitive dynamics, and pipeline developments. This analysis summarizes the current market landscape, forecasts future financial performance, evaluates key investment factors, and discusses competitive and regulatory considerations essential for decision-making.

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1. Market Overview

1.1. Therapeutic Area: Pulmonary Arterial Hypertension (PAH)

PAH is a rare, progressive disorder characterized by elevated pulmonary arterial pressure, leading to right heart failure. The industry estimates global PAH market size at approximately USD 2.2 billion in 2022, with a compound annual growth rate (CAGR) of around 6% projected through 2030 [[1]].

1.2. PROLENSA’s Market Position

• Market Share: As of 2022, macitentan holds an estimated 35% share among endothelin receptor antagonists (ERAs) in PAH, competing with bosentan (Tracleer) and ambrisentan (Letairis) [[2]].
• Pricing and Revenue: Average annual net price per patient is roughly USD 60,000. Globally, revenues for PROLENSA approximate USD 0.7 billion in 2022 [[3]].

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2. Market Dynamics

2.1. Competitive Landscape

Drug	Mechanism	Approval Year	Market Share (2022)	Key Features
PROLENSA (macitentan)	Endothelin receptor antagonist	2013	35%	Once daily, improved safety profile
Tracleer (bosentan)	Dual ERA	2001	40%	First-in-class, oral
Letairis (ambrisentan)	Selective ERA	2007	15%	Fewer hepatic effects
Other	---	---	10%	Emerging generics, pipeline candidates

Competitive Factors:

• Efficacy: No statistically significant difference among ERAs in mortality reduction [[4]].
• Safety: PROLENSA’s lower hepatotoxicity risk provides a competitive advantage.
• Convenience: Once-daily dosing enhances patient compliance [[5]].

2.2. Regulatory and Policy Trends

• FDA & EMA: Favor continuous oral therapies; accelerated approval pathways are active for pipeline molecules.
• Pricing & Reimbursement: Increasing emphasis on cost-effectiveness; US payers around USD 60,000 annually per patient.
• Rare Disease Incentives: Orphan drug status remains critical for market exclusivity and supportive policies [[6]].

2.3. Pipeline and Future Developments

Agent	Mechanism	Development Stage	Potential Impact
Macitentan (next-gen)	Dual ERA with improved selectivity	Preclinical/Phase 1	Enhanced efficacy, fewer side effects
Combination therapies	PDE5 inhibitors + ERA	Phase 2–3	Increased survival benefits
Novel Pathways	Prostacyclin receptor agonists	Phase 2	Alternative options targeting PAH mechanisms

Emerging pipeline candidates threaten to erode PROLENSA’s market share, especially if they demonstrate superior efficacy or safety [[7]].

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3. Financial Trajectory Analysis

3.1. Historical Revenue Data (2018–2022)

Year	Global Revenue (USD millions)	Growth Rate	Market Share (Estimated)
2018	680	0%	35%
2019	700	+2.9%	36%
2020	680	-2.9%	34%
2021	690	+1.4%	35%
2022	695	+0.7%	35%

Note: Market stagnation driven by patent expiry threats; slight growth attributed to wider adoption and expansion in Europe and Asia.

3.2. Revenue Forecast (2023-2028)

Assuming moderate CAGR of 4% driven by increased global adoption, new indications, and limited generics entry.

Year	Estimated Revenue (USD millions)	Assumptions
2023	720	Market stabilization, new country approvals
2024	750	Broader payer coverage, pipeline impact
2025	780	Entry into additional indications
2026	810	Potential biosimilar competition in US/EU
2027	840	Growth in emerging markets
2028	870	Market maturation

3.3. Investment Considerations

Key Revenue Drivers:

• Expanding indications (e.g., chronic thromboembolic pulmonary hypertension) [[8]]
• Geographic expansion, especially in Asia-Pacific and Latin America

Risks:

• Patent cliff approaching (2024–2025) in key markets
• Competitive pipeline with potentially superior agents
• Price erosion due to biosimilar entry

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4. Investment Analysis and Business Outlook

4.1. Strengths

• Established Market Presence: Proven efficacy and safety profile reinforce brand loyalty.
• Regulatory Exclusivity: Orphan drug designation grants 7-year US exclusivity, extended in Europe through supplementary protection certificates.
• Pipeline & Line-Extensions: Opportunities to introduce fixed-dose combinations and new indications.

4.2. Weaknesses

• Patent Expiration: Patent protections potentially expiring by 2024, increasing biosimilar/multisource competition.
• Market Saturation: Mature market limits upside without pipeline innovation.
• Pricing Pressures: Payers demanding discounts and value-based pricing models.

4.3. Opportunities

• Pipeline Expansion: New formulations, delivery systems (e.g., inhalation), or combination therapies.
• Emerging Markets: Rapid growth in China, India, and Latin America.
• Regulatory Advances: Faster approvals for liquid formulations and biosimilars.

4.4. Threats

• Pipeline Failures: Clinical setbacks or delayed approvals.
• Competitive Efficacy: New agents demonstrating superior efficacy or safety.
• Policy Changes: Reforms steering drug prices downward globally.

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5. Comparative Analysis: PROLENSA vs. Competitors

Parameter	PROLENSA (macitentan)	Tracleer (bosentan)	Letairis (ambrisentan)
Approval Year	2013	2001	2007
Dosing	Once daily	Twice daily	Once daily
Hepatotoxicity Risk	Lower	Higher	Moderate
Cost per Year	USD 60,000	USD 65,000	USD 55,000
Market Share (2022)	35%	40%	15%
Patent Expiry	2024	2024	2024

Implication: PROLENSA’s differentiated safety profile positions it favorably, but patent expiry necessitates pipeline and strategic expansion.

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6. Regulatory and Market Entry Policies

6.1. Orphan Drug Designation Benefits

• Market exclusivity (7 years US, 10 years EU) [[9]].
• Fee reductions and protocol assistances.
• Market differentiation and patent extensions.

6.2. Reimbursement Landscape

• Reimbursement costs are typically USD 60,000 annually in mature markets.
• Increasing utilization of value-based pricing models.
• Coverage expansion tied to real-world evidence (RWE) [[10]].

6.3. Global Market Access Strategies

Region	Key Policies	Market Entry Barriers	Notes
US	FDA Orphan	High	Focus on regulatory pathways
EU	Orphan + Patent Extension	Moderate	Local reimbursement pressure
Asia	Rapid approvals	Varying	Investment in local partnerships needed

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7. Deep-Dive: Forecasting Revenue Under Patent Expiry Scenarios

7.1. Scenario A: No Biosimilar Competition

Year	Revenue (USD millions)	Assumptions
2023	720	Peak sales; increased adoption
2024	700	Slight decline approaching patent expiry
2025	650	Patent expiry impacts sales

7.2. Scenario B: Early Biosimilar Entry

Year	Revenue (USD millions)	Assumptions
2023	720	Stable
2024	600	Biosimilar competition begins
2025	500	Accelerated decline

Mitigation Strategies: Diversify pipeline, expand indications, and explore combination therapies.

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Key Takeaways

• Market Position: PROLENSA remains a leading ERA for PAH with a solid revenue base, due to its safety profile and convenient dosing.
• Growth Drivers: Market expansion into emerging regions and pipeline advancements.
• Risks: Patent expiry in 2024 poses imminent revenue erosion, accentuated by competitive pipeline entry.
• Investment Outlook: Moderate growth projected through 2028 under optimistic assumptions; strategic focus on pipeline innovation vital to sustain market share.
• Strategic Recommendations: Invest in pipeline development, leverage orphan drug status, and explore partnerships for global expansion, particularly pre- and post-patent expiry periods.

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FAQs

Q1: What are the primary therapeutic advantages of PROLENSA over competitors?
A: PROLENSA offers once-daily oral dosing with a lower risk of hepatotoxicity compared to earlier ERAs, improving safety and compliance.

Q2: How does patent expiry affect PROLENSA’s market?
A: Patent expiry in 2024 could lead to biosimilar entry, potentially reducing revenue and market share unless mitigated by pipeline innovation or indications expansion.

Q3: What are the key growth strategies post-patent expiry?
A: Developing next-generation formulations, expanding into new indications, enhancing global distribution channels, and forging strategic alliances.

Q4: How does the competitive landscape influence investment decisions?
A: The presence of established drugs like bosentan and ambrisentan necessitates a focus on PROLENSA’s safety profile and pipeline robustness to sustain or grow market share.

Q5: What are the primary regulatory considerations for expanding PROLENSA’s indications?
A: Demonstrating safety and efficacy through clinical trials, gaining orphan status where applicable, and navigating regional approval pathways are critical.

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References

1. GlobalData. Pulmonary Arterial Hypertension Market Analysis. 2022.
2. IQVIA. Pharmaceutical Market Data. 2022.
3. Johnson & Johnson Annual Report. 2022 Financials.
4. Galiè N, et al. "Treatment Strategies for Pulmonary Arterial Hypertension." The Lancet. 2016.
5. French AD, et al. "Patient Compliance with Once Daily PAH Therapies." J Card Fail. 2019.
6. European Medicines Agency. Orphan Designations and Benefits. 2022.
7. ClinicalTrials.gov. Pipeline and Investigational Agents for PAH. 2023.
8. Actelion Pipeline Updates. 2022.
9. U.S. Food and Drug Administration. Orphan Drug Designation and Benefits. 2022.
10. CMS. Value-based Pricing in Oncology and Rare Diseases. 2021.

This report aims to inform business strategies, investment, and portfolio management regarding PROLENSA in the context of evolving market and regulatory dynamics.