LOTEMAX Drug Patent Profile

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

Lotemax is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos. and is included in five NDAs. There are two patents protecting this drug.

The generic ingredient in LOTEMAX is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotemax

A generic version of LOTEMAX was approved as loteprednol etabonate by SENTISS on April 17^th, 2019.

Summary for LOTEMAX

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	22
Patent Applications:	4,390
Drug Prices:	Drug price information for LOTEMAX
Drug Sales Revenues:	Drug sales revenues for LOTEMAX
What excipients (inactive ingredients) are in LOTEMAX?	LOTEMAX excipients list
DailyMed Link:	LOTEMAX at DailyMed

See drug prices for LOTEMAX

See drug sales revenues for LOTEMAX

Recent Clinical Trials for LOTEMAX

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

Sponsor	Phase
Thomas Chester, OD	Phase 4
Illinois College of Optometry	Early Phase 1
Shiraz University of Medical Sciences	Phase 4

See all LOTEMAX clinical trials

Pharmacology for LOTEMAX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for LOTEMAX

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 Inc	LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872-001	Sep 28, 2012	AB	RX	Yes	Yes
Pharmos	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020841-001	Mar 9, 1998		DISCN	No	No
Bausch And Lomb	LOTEMAX	loteprednol etabonate	OINTMENT;OPHTHALMIC	200738-001	Apr 15, 2011		RX	Yes	Yes
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	AB	RX	Yes	Yes
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219-001	Feb 22, 2019		RX	Yes	Yes			Y
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219-001	Feb 22, 2019		RX	Yes	Yes			Y

Expired US Patents for LOTEMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmos	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020841-001	Mar 9, 1998
Bausch And Lomb Inc	LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872-001	Sep 28, 2012
Pharmos	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020841-001	Mar 9, 1998
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998

International Patents for LOTEMAX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9832421
European Patent Office	0730443	SUSPENSION D'ETABONATE DE LOTEPREDNOL (SUSPENSION OF LOTEPREDNOL ETABONATE)
South Korea	20000070492
Canada	2278802	COMPOSITIONS OPHTALMIQUES COMPORTANT DE LA GLYCERINE ET DU PROPYLENE GLYCOL (OPHTHALMIC COMPOSITIONS INCLUDING GLYCERIN AND PROPYLENE GLYCOL)
Australia	7259181
South Korea	100472132

LOTEMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LOTEMAX SM

Introduction

LOTEMAX SM, a formulation of loteprednol etabonate ophthalmic gel, is a significant player in the ophthalmic pharmaceutical market, particularly for treating postoperative inflammation and pain following ocular surgery. Here, we delve into the market dynamics and financial trajectory of LOTEMAX SM.

Mechanism of Action and Clinical Use

LOTEMAX SM is a corticosteroid indicated for the treatment of postoperative inflammation and pain after ocular surgery. It boasts a submicron particle size, which enhances drug dissolution in tears and provides twice the penetration to the aqueous humor compared to the previous LOTEMAX Gel 0.5% formulation[1][4].

Market Assessment

The market for LOTEMAX SM is expected to evolve significantly due to several factors:

Extensive Research and Healthcare Spending

The market scenario for postoperative pain and acute ocular pain is anticipated to change with extensive research and increased healthcare spending globally. This trend is expected to expand the market size, allowing drug manufacturers to penetrate deeper into the market[1][4].

Novel Therapies and Market Competition

Companies are developing novel therapies that focus on improving disease conditions, assessing challenges, and seeking opportunities. Other emerging products for postoperative pain are expected to provide tough competition to LOTEMAX SM, and the launch of late-stage therapies will significantly impact the market[1][4].

Regulatory Milestones and Developmental Activities

The report provides detailed insights into the regulatory milestones and developmental activities of LOTEMAX SM. This includes clinical trials information, trial interventions, and the current development scenario, which are crucial for understanding the drug's market position[1][4].

Financial Performance

Revenue Trends

In the second quarter of 2022, Bausch + Lomb, the manufacturer of LOTEMAX SM, reported a decrease in the Ophthalmic Pharmaceuticals segment revenues. This segment saw a decline of $25 million, or 13%, primarily due to the loss of exclusivity in the branded portfolio, including the LOTEMAX franchise, and competitive market dynamics in the generics portfolio[2].

Segment Performance

The Surgical segment, which includes consumables and intraocular lenses, showed a slight decrease in revenues but an organic increase of approximately 7% when excluding the impact of foreign exchange and divestitures. However, the Ophthalmic Pharmaceuticals segment, where LOTEMAX SM is categorized, faced challenges due to market competition and loss of exclusivity[2].

Operating Results and Net Income

The operating income for Bausch + Lomb in the second quarter of 2022 was $56 million, a decrease from $58 million in the same period of 2021. This decrease was driven by increased SG&A expenses, partly offset by a decrease in amortization of intangible assets and an increase in revenues. The net income for the second quarter of 2022 was $5 million, down from $44 million in the previous year, primarily due to increased interest expenses and decreased operating results[2].

Cash Flow

Cash flow from operations for the second quarter of 2022 was $156 million, a significant decrease from $250 million in the same period of 2021. This decline was attributed to changes in operating assets and liabilities, strategic inventory build-up, and the timing of payments[2].

Market Forecast

Sales Projections

The market forecast for LOTEMAX SM indicates that the drug will continue to play a significant role in the treatment of postoperative inflammation and pain. The report provides forecasted sales data from 2023 to 2032, which will help clients in decision-making regarding their therapeutic portfolios[1][4].

Competitive Landscape

The competitive landscape for LOTEMAX SM is expected to remain dynamic with the emergence of new therapies. The report highlights that other emerging products will give tough market competition to LOTEMAX SM, and the launch of late-stage emerging therapies will significantly impact the market[1][4].

SWOT Analysis

Strengths

• Advanced Formulation: LOTEMAX SM offers a submicron particle size, enhancing drug dissolution and penetration to the aqueous humor.
• Clinical Efficacy: The drug is clinically proven for treating postoperative inflammation and pain following ocular surgery.
• Market Presence: LOTEMAX SM has an established presence in the ophthalmic pharmaceutical market.

Weaknesses

• Loss of Exclusivity: The loss of exclusivity in the branded portfolio has impacted revenues.
• Market Competition: The segment faces intense competition from generics and other emerging therapies.

Opportunities

• Increasing Healthcare Spending: Extensive research and increased healthcare spending globally offer opportunities for market expansion.
• Novel Approaches: Developing novel therapies to improve disease conditions can enhance market position.

Threats

• Emerging Therapies: The launch of late-stage emerging therapies poses a significant threat to LOTEMAX SM's market dominance.
• Regulatory Changes: Changes in regulatory environments can impact the drug's market trajectory.

Key Takeaways

• LOTEMAX SM is a significant player in the ophthalmic pharmaceutical market, particularly for postoperative inflammation and pain.
• The market is expected to evolve with extensive research and increased healthcare spending.
• The drug faces challenges due to loss of exclusivity and market competition but has opportunities for growth with novel approaches.
• Financial performance has been impacted by increased SG&A expenses and competitive market dynamics.

FAQs

Q: What is LOTEMAX SM used for? A: LOTEMAX SM is used for treating postoperative inflammation and pain following ocular surgery.

Q: How does LOTEMAX SM differ from its previous formulation? A: LOTEMAX SM has a submicron particle size, which enhances drug dissolution in tears and provides twice the penetration to the aqueous humor compared to the previous LOTEMAX Gel 0.5% formulation.

Q: What are the key challenges facing LOTEMAX SM in the market? A: The key challenges include the loss of exclusivity in the branded portfolio and intense competition from generics and emerging therapies.

Q: How is the market forecast for LOTEMAX SM? A: The market forecast indicates that LOTEMAX SM will continue to play a significant role, with forecasted sales data provided from 2023 to 2032.

Q: What are the opportunities for LOTEMAX SM in the future market? A: Opportunities include increasing healthcare spending globally and developing novel therapies to improve disease conditions.

Sources

1. GlobeNewswire: "United States LOTEMAX SM (Loteprednol Etabonate Ophthalmic Gel) Drug Insights and Market Forecasts Report 2019-2022 and 2023-2032"[1].
2. PR Newswire: "Bausch + Lomb Announces Second-Quarter 2022 Results"[2].
3. GlobeNewswire: "United States LOTEMAX SM (Loteprednol Etabonate Ophthalmic Gel) Drug Market Insights and Forecast Report 2022-2032"[4].
4. Bausch Health: "Financial Results - Bausch Health Companies Inc."[5].