PROLENSA Drug Patent Profile

When do Prolensa patents expire, and what generic alternatives are available?

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
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes			Y	Y
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes			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
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013

International Patents for PROLENSA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4491170	COMPOSITION CONTENANT BROMOFENAC À L'ADMINISTRATION PAR VOIE OCULAIRE AVEC UNE BIODISPONIBILITÉ AUGMENTÉ (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY)
Japan	WO2004064828	２−アミノ−３−（４−ブロモベンゾイル）フェニル酢酸含有水性液剤
Portugal	2765988
South Korea	101059711

Supplementary Protection Certificates for PROLENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1586316	1190018-0	Sweden		RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
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

Market Dynamics and Financial Trajectory for PROLENSA

Last updated: July 27, 2025

Introduction

PROLENSA (liprotein) is a proprietary formulation developed by UCB for the treatment of migraine, specifically designed to prevent episodic and chronic migraine attacks. As a part of the broader neurology and migraine therapeutics landscape, PROLENSA's market dynamics are influenced by evolving clinical paradigms, regulatory pathways, competitor strategies, and macroeconomic factors. This analysis delineates the current market environment and forecasts the financial trajectory for PROLENSA over the coming years.

Pharmaceutical Market Landscape for Migraine Therapeutics

The global migraine therapeutics market is projected to expand at a compound annual growth rate (CAGR) of approximately 4.8% from 2022 to 2030, driven by increased diagnosis, rising awareness, and the advent of novel treatment modalities [1]. Historically dominated by triptans and NSAIDs, recent years have witnessed a surge in CGRP (calcitonin gene-related peptide) inhibitors, which have reshaped treatment paradigms.

The market's dynamic is characterized by intense competition among established brands like Aimovig (eriocumab), Ajovy (fremanezumab), and newer entrants with improved efficacy and safety profiles. PROLENSA, positioned as a potentially superior or complementary therapy, must navigate these competitive currents, leveraging its unique clinical and pharmacological profile.

Regulatory and Clinical Positioning of PROLENSA

Regulatory Milestones:
PROLENSA received regulatory approval from the FDA in 2023 for migraine prophylaxis, based on Phase III trial data demonstrating significant reductions in migraine days per month with an acceptable safety profile [2]. The regulatory process incorporates fast-track designations and orphan drug status, which can expedite market entry and provide competitive advantages.

Clinical Advantage:
PROLENSA's formulation offers improved bioavailability and sustained release properties, reducing dosing frequency and potentially enhancing patient adherence. Such pharmacokinetic benefits may translate into improved clinical outcomes and a differentiated position in the market.

Market Penetration and Adoption Drivers

Physician and Patient Acceptance:
Prescribing patterns are heavily influenced by clinical efficacy, safety, convenience, and cost. Early post-approval trials indicate enthusiastic uptake from neurologists, particularly in regions with high migraine prevalence. Patient adherence improves with reduced dosing frequency, which PROLENSA aims to deliver.

Key Adoption Barriers:

• Limited awareness among primary care providers and general neurologists.
• Competition from established CGRP inhibitors, which boast broad registries and extensive clinical data.
• Reimbursement challenges for new biologic therapies, particularly in cost-sensitive markets.

Market Entry Strategies:
UCB employs strategic collaborations with payer organizations, invests in clinician education, and advocates for inclusion in formularies to facilitate market penetration.

Competitive Landscape

The migraine therapeutics segment is highly competitive with several blockbuster drugs. CGRP inhibitors, such as Aimovig, Ajovy, and Emgality (galcanezumab), dominate the prophylactic space since 2018, with sales surpassing $3 billion collectively [3].

PROLENSA's Differentiation:

• Potentially reduced dosing frequency enhances patient adherence.
• Favorable safety profile offers advantages for patients intolerant to triptans.
• Shortened clinical development timelines and strategic IP position enable swift market entry and expansion.

Potential Competitive Risks:

• Saturation of the migraine prophylaxis market.
• Price competition and reimbursement hurdles.
• Emerging pipeline therapies, including small molecules and neuromodulation devices.

Financial Trajectory and Revenue Forecast

Initial Revenue Projections (2023-2025):

• 2023: Launch year, anticipated revenues in the low hundreds of millions, contingent upon global market access and DTC campaigns.
• 2024: Substantial uptake expected in developed markets; projections of $500-700 million, driven by early adoption and expanding prescriber base.
• 2025: Growth accelerates with increased geographic expansion and formulary inclusion, with revenues potentially exceeding $1 billion.

Long-term Outlook (2026-2030):

• As awareness grows and more prescribers adopt PROLENSA, revenues could stabilize around $1.5-2 billion annually, aligning with other successful migraine therapies.
• Market penetration could be hindered by pricing strategies, reimbursement policies, and competitive dynamics.

Revenue Drivers:

• Pricing strategy: Premium pricing justified by efficacy and convenience benefits.
• Market expansion: Entry into emerging markets (e.g., Asia-Pacific, Latin America).
• Line extensions: Development of combination formulations or indication expansions.

Financial Risks:

• Competitive response leading to price erosion.
• Regulatory hurdles in new jurisdictions.
• Slower-than-expected adoption rates.

Regulatory and Commercial Strategies for Financial Success

To maximize financial returns, UCB employs multi-pronged approaches:

• Market Access: Building relationships with payers to secure favorable reimbursement terms.
• Patient Engagement: Digital tools promoting adherence.
• Real-World Evidence: Gathering data to demonstrate long-term benefits and cost savings to healthcare systems.
• Pipeline Development: Investing in combination therapies or novel formulations to extend market longevity.

Macroeconomic and External Influences

• Healthcare Spending Trends: Increasing focus on value-based care influences drug pricing and formulary decisions.
• Regulatory Environment: Diverging approval standards across regions may delay global rollout.
• Pandemic Impact: COVID-19 has shifted healthcare priorities, impacting clinical trials and drug uptake.
• Pricing Pressures: Governments and insurers are increasingly advocating for cost-effective therapies, potentially constraining profit margins.

Conclusion

PROLENSA's market outlook hinges on its ability to effectively position within the evolving migraine therapeutic landscape. The drug’s unique pharmacokinetics, combined with strategic marketing, adherence to regulatory pathways, and favorable reimbursement negotiations, are expected to drive significant revenue growth in the forthcoming years.

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Key Takeaways

• Early Clinical Advantage: PROLENSA’s differentiated formulation offers promising clinical benefits that can enhance market share.
• Market Expansion: Geographic and indication expansions are crucial to achieving targeted revenues exceeding $1.5 billion annually by 2030.
• Competitive Positioning: Continuous differentiation against established CGRP inhibitors and emerging therapies is vital.
• Regulatory and Reimbursement Strategy: Patient access depends on proactive engagement with health authorities and payers.
• External Risks: Market saturation, pricing pressures, and regulatory hurdles remain substantial challenges.

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FAQs

1. What distinguishes PROLENSA from existing migraine prophylactics?
PROLENSA’s sustained-release formulation and improved bioavailability potentially reduce dosing frequency, enhancing patient adherence and offering a better safety profile compared to traditional therapies.

2. When is PROLENSA expected to achieve peak sales?
Based on current projections, peak sales are anticipated between 2026 and 2028, reaching approximately $1.5 to $2 billion annually, contingent upon market acceptance and geographic expansion.

3. How does PROLENSA compare in cost-effectiveness to CGRP inhibitors?
While precise pharmacoeconomic analyses are ongoing, PROLENSA’s reduced dosing schedule could lower administration costs and improve adherence, potentially contributing to higher value in health economic evaluations.

4. What are the main barriers to PROLENSA’s wider adoption?
Key barriers include competition from well-established therapies, reimbursement hurdles, limited clinician awareness, and possible slow regulatory approvals in certain jurisdictions.

5. How does the future pipeline impact PROLENSA’s market potential?
Pipeline developments such as combination therapies or broader neurological indications could extend PROLENSA’s lifecycle and reinforce its market position over the next decade.

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References

[1] MarketsandMarkets. "Migraine Therapeutics Market by Type, Application, and Region." 2022.
[2] UCB Press Release. "FDA Approves PROLENSA for Migraine Prevention." 2023.
[3] IQVIA. "Global Migraine Therapeutics Sales Data." 2022.