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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in fifteen 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:	27
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	5
Patent Applications:	4,758
Drug Prices:	Drug price information for PROLENSA
Drug Sales Revenues:	Drug sales revenues 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
Ocular Therapeutix, Inc.	Phase 4
Sight Medical Doctors PLLC	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 ten 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	8,927,606
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	8,871,813		Y
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	9,561,277

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	9,144,609
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,669,290
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	9,561,277
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,927,606

International Patents for PROLENSA

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

Country	Patent Number	Title	Estimated Expiration
China	100341498
Canada	3043910	PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID)
Japan	4500261
Germany	602004013420

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	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

PROLENSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prolensa (Bromfenac Ophthalmic Solution)

Introduction

Prolensa, a nonsteroidal anti-inflammatory drug (NSAID) in the form of bromfenac ophthalmic solution 0.07%, is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. This article delves into the market dynamics and financial trajectory of Prolensa, highlighting key milestones, market size, and the impact of generic approvals.

Market Size and Revenue

The market for Prolensa is substantial, driven by the increasing number of cataract surgeries globally. As of 2018, the branded market sales for Prolensa were approximately $113 million for the last twelve months[1].

More recently, the estimated market size for the generic version of Prolensa has been reported to be around $168 million for the 12 months ended March 2024, according to IQVIA data cited by Alembic Pharma[4].

Indications and Usage

Prolensa is specifically designed to treat postoperative inflammation and reduce ocular pain following cataract surgery. Its efficacy in managing these symptoms makes it a crucial product in the ophthalmic care segment.

Generic Approvals and Market Impact

The approval of generic versions of Prolensa has significant implications for the market. Perrigo received tentative FDA approval for the generic version of Prolensa in 2018, following a settlement with Bausch & Lomb Inc.[1].

More recently, Alembic Pharma received USFDA approval for its generic bromfenac ophthalmic solution, which is therapeutically equivalent to Prolensa. This approval is expected to increase competition in the market, potentially reducing prices and making the treatment more accessible to patients[4].

Competitive Landscape

The ophthalmic NSAID market is competitive, with several players vying for market share. Bausch & Lomb, the original manufacturer of Prolensa, faces competition from generic manufacturers like Perrigo and Alembic Pharma. The entry of generics typically leads to a reduction in market share for the branded product but also expands the overall market by making the treatment more affordable.

Financial Performance of Key Players

Bausch & Lomb

As part of Valeant Pharmaceuticals (now Bausch Health), Bausch & Lomb's financial performance is tied to the broader company's results. In 2017, Valeant Pharmaceuticals reported significant debt reduction efforts and divestitures to stabilize the company. The sale of non-core assets, such as the CeraVe®, AMBI®, and AcneFree™ products, helped in reducing debt and focusing on core therapeutic areas[3].

Perrigo

Perrigo's financial performance is influenced by its generic product pipeline, including the approval of the generic version of Prolensa. The company's focus on delivering quality, affordable healthcare products has been a key driver of its financial trajectory. However, specific financial details related to Prolensa are not separately disclosed in Perrigo's overall financial reports[1].

Alembic Pharma

Alembic Pharma's approval for the generic version of Prolensa is expected to contribute to its revenue growth. The company's financial performance will likely be positively impacted by the entry into this lucrative market segment, although the exact financial implications will depend on market penetration and pricing strategies[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Prolensa. FDA approvals, whether for branded or generic versions, are pivotal in determining market entry and competition. The FDA's approval process ensures that generic products are therapeutically equivalent to the branded versions, thereby maintaining quality and efficacy standards.

Patient Access and Affordability

The availability of generic versions of Prolensa is expected to improve patient access to this essential ophthalmic treatment. Generic drugs are generally more affordable than their branded counterparts, which can lead to increased prescription rates and better patient outcomes.

Industry Trends and Future Outlook

The ophthalmic care market is evolving, with advancements in surgical techniques and postoperative care. The trend towards generic medications is likely to continue, driven by cost considerations and regulatory approvals. As the global population ages, the demand for cataract surgeries and associated treatments like Prolensa is expected to rise, providing a stable market for both branded and generic versions.

"The approved product is equivalent to Prolensa Ophthalmic Solution, with an estimated market size of USD 168 million for 12 months ended March 2024, Alembic said citing IQVIA data."[4]

Conclusion

The market dynamics for Prolensa are characterized by a significant and growing demand driven by cataract surgeries, competitive pressures from generic approvals, and a regulatory environment that ensures therapeutic equivalence. The financial trajectory of Prolensa and its generic versions is influenced by market size, competition, and the broader financial performance of the companies involved.

Key Takeaways

• Market Size: The estimated market size for the generic version of Prolensa is around $168 million for the 12 months ended March 2024.
• Generic Approvals: Approvals from companies like Perrigo and Alembic Pharma have increased competition and are expected to make the treatment more affordable.
• Regulatory Environment: FDA approvals are crucial for market entry and ensuring therapeutic equivalence.
• Patient Access: Generic versions are expected to improve patient access to this essential ophthalmic treatment.
• Future Outlook: The demand for Prolensa is expected to rise with the increasing number of cataract surgeries globally.

FAQs

Q: What is Prolensa used for? A: Prolensa is used for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Q: Who are the key players in the Prolensa market? A: The key players include Bausch & Lomb (the original manufacturer), Perrigo, and Alembic Pharma (generic manufacturers).

Q: What is the estimated market size for the generic version of Prolensa? A: The estimated market size for the generic version of Prolensa is around $168 million for the 12 months ended March 2024[4].

Q: How do generic approvals affect the market for Prolensa? A: Generic approvals increase competition, potentially reducing prices and making the treatment more accessible to patients.

Q: What is the impact of FDA approvals on the market for Prolensa? A: FDA approvals ensure that generic products are therapeutically equivalent to the branded versions, maintaining quality and efficacy standards.

Sources

1. Perrigo Announces Tentative FDA Approval For The Generic Version Of Prolensa Ophthalmic Solution - PR Newswire
2. Pros Holdings, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results - Pros Holdings, Inc.
3. VALEANT PHARMACEUTICALS INTERNATIONAL, INC. 2016 Annual Report - Valeant Pharmaceuticals
4. Alembic Pharma gets USFDA nod for generic Bromfenac ophthalmic solution - The Economic Times
5. Prothena Reports First Quarter 2024 Financial Results and Business Highlights - Prothena Corporation PLC