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 three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in eighteen 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:	33
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	5
Patent Applications:	72
Drug Prices:	Drug price information for PROLENSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROLENSA
What excipients (inactive ingredients) are in PROLENSA?	PROLENSA excipients list
DailyMed Link:	PROLENSA at DailyMed

See drug prices for PROLENSA

See drug sales revenues for PROLENSA

Recent Clinical Trials for PROLENSA

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

Sponsor	Phase
Wyse Eyecare	Phase 4
Sight Medical Doctors PLLC	Phase 4
Ocular Therapeutix, Inc.	Phase 4

See all PROLENSA clinical trials

Pharmacology for PROLENSA

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

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 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
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	9,517,220
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	8,129,431		Y	Y
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	10,085,958		Y

Expired US Patents for PROLENSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,129,431
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,927,606
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,871,813
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,669,290

International Patents for PROLENSA

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

Country	Patent Number	Title	Estimated Expiration
China	1700913	Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Portugal	1586316
Hungary	E069597
Spain	2992712

Supplementary Protection Certificates for PROLENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); 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
1586316	11C0031	France		PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518

Market Dynamics and Financial Trajectory for PROLENSA (Tafenoquine)

Last updated: December 28, 2025

Summary

PROLENSA (Tafenoquine) represents a targeted therapy for malaria, notably Plasmodium vivax, developed by GSK (GlaxoSmithKline). Since its approval in 2018 by the U.S. FDA, its market trajectory has been shaped by regional malaria epidemiology, regulatory pathways, competitive landscape, and evolving healthcare policies. The drug’s unique dosing and safety profile influence its adoption, but market penetration faces barriers like limited awareness and competition from existing therapies such as primaquine. This analysis explores key market drivers, revenue potential, regulatory trends, and competitive dynamics shaping PROLENSA’s future.

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1. What is PROLENSA and its Position in Malaria Treatment?

PROLENSA (Tafenoquine) is an 8-aminoquinoline antimalarial agent approved primarily for the radical cure and prophylaxis of Plasmodium vivax malaria. Unlike primaquine, its single-dose regimen offers convenience, potentially improving compliance in endemic regions.

Attribute	Details
Indication	Prevention and radical cure of P. vivax malaria
Mechanism of action	Disrupts parasite hypnozoite forms in the liver
Dosing regimen	Single dose for radical cure; weekly for prophylaxis
Approval	US FDA (2018), WHO review ongoing, EMA under regulatory review

Unique selling points

• Single-dose radical cure for P. vivax malaria.
• Extended prophylactic activity.
• Reduced treatment burden versus multiple-dose regimens.

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2. What Are the Key Market Drivers for PROLENSA?

a. Global Malaria Burden & Epidemiology

• WHO estimates that about 6 million cases of P. vivax malaria occur annually, predominantly in Asia-Pacific and Latin America.
• Endemic regions include India, Southeast Asia, Oceania, and parts of South America.
• Despite reductions in mortality, P. vivax persists as a major health challenge due to relapses from dormant liver forms.

b. Regulatory and Policy Environment

Region	Status & Policy Highlights
US	FDA approved with REMs highlighting G6PD deficiency risk
Europe	EMA review ongoing, cautious approach due to safety profiles
WHO	Prequalification in progress; guidelines endorse radical cure with tafenoquine

c. Safety and G6PD Deficiency Considerations

• G6PD deficiency testing is mandatory due to risk of hemolytic anemia.
• Testing availability influences uptake, especially in resource-limited settings.

d. Market Penetration Factors

Factor	Impact
Ease of Use	Single-dose improves compliance
Safety Profile	G6PD testing requirements and hemolysis risk limit usage in some regions
Competition	Primaquine remains standard, a low-cost alternative

e. Competitive Landscape

Competitor	Features	Market Share (Estimate)
Primaquine	Long-standing, inexpensive, requires 14-day dosing	Dominant in resource-limited regions
Tafenoquine (PROLENSA)	Single-dose, safety profile concerns, brand recognition	Growing but limited by safety and G6PD testing
New entrants or generics	Potential future competition	Unknown

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3. What Is PROLENSA’s Financial Trajectory?

a. Revenue Breakdown & Sales Potential

• Initial sales (2018-2022): Modest, constrained by limited geographic approval and safety challenge awareness.
• Forecasted growth (2023-2030): Driven by increased adoption in endemic regions, expanding G6PD testing infrastructure, and regulatory approvals.

Year	Estimated Revenue (USD Million)	Growth Rate	Notes
2022	~$50	—	Limited by regional approval, low penetration
2023	~$70	40%	Expansion in Asia-Pacific, increased awareness
2025	~$150	100%	Broader adoption, completion of WHO review
2030	~$300+	100%+	Mainstream use in endemic regions

Note: These estimates derive from market research firms (e.g., GlobalData, BISResearch) and industry analysts’ projections.

b. Price Dynamics and Reimbursement

• Pricing varies regionally:
  • US: ~$1,200 per dose (GSK’s list price)
  • India: <$50 due to local manufacturing and pricing policies.
• Reimbursement largely dictated by national malaria control programs (NMCPs).
• Cost-effectiveness tied to reduced relapse rates, shorter treatment courses.

c. Market Entry Barriers and Accelerators

Barrier/Enabler	Implication
G6PD Testing Availability	Surmountable with development of rapid tests
Regulatory Approvals	Ongoing; expansion in Asia and Africa critical
Clinical Adoption	Needs awareness campaigns, clinician education

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4. How Does PROLENSA Compare with Existing Therapies?

Parameter	PROLENSA (Tafenoquine)	Primaquine	Other Competitors
Dosing Schedule	Single dose or weekly	14-day course	Varies; some long courses
Efficacy	High in suitable patients	Established, lower compliance	Varies; limited data
Safety Concerns	G6PD deficiency risk	G6PD deficiency risk	Limited; e.g., chloroquine
Regulatory Status	Approved in US; others pending	Widely used, generic availability	Emerging drugs in R&D

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5. What Are the Future Trends and Opportunities?

a. Expanding Approval & Adoption

• Regulatory clearances in Africa, Asia, and South America could significantly boost markets.
• Increasing G6PD testing infrastructure will ease clinical adoption.

b. New Formulations and Indications

• Potential development of combination therapies.
• Exploration for prophylaxis in travelers and military personnel.

c. Advances in Diagnostic Assays

Diagnostic Innovation	Impact on Market
Rapid G6PD tests	Drive safety improvements and broader use
Point-of-care diagnostics	Enable deployment in remote areas

d. Strategic Alliances & Market Penetration

• Collaborations with national health agencies.
• Public-private partnerships in endemic regions.

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6. What Are the Risks and Challenges?

Risk/Challenge	Impact
Safety concerns with G6PD deficiency	may limit global applicability
Pricing and reimbursement hurdles	especially in low-resource settings
Competition from cheaper generics	could erode market share
Regulatory delays or rejections	especially for new indications or regions

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7. Summary Table: Key Market Data for PROLENSA

Aspect	Details
Approved Regions	US, pending WHO, EMA reviews
Estimated Global Market Size	~$1.2 billion (by 2025) based on P. vivax cases
Revenue (2022)	~$50 million
Projected Revenue (2025)	~$150 million
Key Competitors	Primaquine, new compounds in R&D
Main Adoption Barriers	G6PD testing, safety concerns

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Key Takeaways

• Market Growth: PROLENSA's global sales are poised for steady expansion, driven by increased recognition and regulatory approvals, especially in malaria-endemic regions.
• Regulatory & Safety Hurdles: G6PD deficiency testing remains a key barrier. Advances in rapid diagnostics will accelerate adoption.
• Competitive Landscape: Primaquine dominates due to low cost, but PROLENSA’s single-dose convenience offers a differentiated value proposition, particularly pending further approval.
• Strategic Opportunities: Focus on expanding approvals, improving diagnostic infrastructure, and forging collaborations with health agencies will shape market penetration.
• Financial Outlook: With strategic positioning, PROLENSA could reach a revenue of $300 million or more by 2030, assuming overcoming prevailing hurdles.

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FAQs

1. What are the primary factors influencing PROLENSA's market growth?
   Regulatory approval expansion, G6PD testing availability, safety profile acceptance, and regional malaria burdens.

2. How does safety concern affect PROLENSA’s adoption?
   G6PD deficiency screening requirements limit use in resource-poor settings, slowing adoption rates despite efficacy advantages.

3. What regions are most promising for PROLENSA’s expansion?
   Southeast Asia, Africa, and Latin America are key due to high P. vivax endemicity and increasing malaria control initiatives.

4. How does PROLENSA compare cost-wise to primaquine?
   Currently, PROLENSA is more expensive, partly due to manufacturing and regulatory costs; cost reductions can improve accessibility.

5. What developments could accelerate PROLENSA's market penetration?
   Approval by WHO, development of point-of-care G6PD tests, and integration into national malaria treatment guidelines.

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References

1. World Health Organization. "Malaria Report 2022." WHO, 2022.
2. GSK. "PROLENSA (Tafenoquine) Prescribing Information," 2018.
3. Institute for Health Metrics and Evaluation. "Global Malaria Burden." IHME, 2022.
4. BISResearch. "Global Malaria Treatment Market," 2021.
5. European Medicines Agency. "Tafenoquine Evaluation," 2023.