LOTEMAX SM Drug Patent Profile

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

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

This drug has thirty patent family members in thirteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotemax Sm

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

Summary for LOTEMAX SM

International Patents:	30
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	22
Drug Prices:	Drug price information for LOTEMAX SM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOTEMAX SM
What excipients (inactive ingredients) are in LOTEMAX SM?	LOTEMAX SM excipients list
DailyMed Link:	LOTEMAX SM at DailyMed

See drug prices for LOTEMAX SM

Recent Clinical Trials for LOTEMAX SM

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 SM clinical trials

Pharmacology for LOTEMAX SM

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for LOTEMAX SM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOTEMAX SM	Ophthalmic Gel	loteprednol etabonate	0.38%	208219	1	2022-11-14

US Patents and Regulatory Information for LOTEMAX SM

LOTEMAX SM 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 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

International Patents for LOTEMAX SM

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

Country	Patent Number	Title	Estimated Expiration
Portugal	3721868
Poland	3470059
Hungary	E041945
European Patent Office	3470059	COMPOSITION DE SUSPENSION OPHTALMIQUE (OPHTHALMIC SUSPENSION COMPOSITION)
Australia	2023248145	Ophthalmic suspension composition
European Patent Office	4268850	COMPOSITION DE SUSPENSION OPHTALMIQUE (OPHTHALMIC SUSPENSION COMPOSITION)

Market Dynamics and Financial Trajectory for LOTEMAX SM

Introduction

LOTEMAX SM, a formulation of loteprednol etabonate ophthalmic gel at 0.38%, has been approved for the treatment of postoperative inflammation and pain following ocular surgery. This article delves into the market dynamics and financial trajectory of LOTEMAX SM, providing insights into its clinical efficacy, market forecast, competitive landscape, and regulatory milestones.

Clinical Efficacy and Safety

LOTEMAX SM has demonstrated significant clinical efficacy in treating postoperative inflammation and pain. In two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies involving 742 subjects, LOTEMAX SM showed a higher percentage of patients achieving complete resolution of anterior chamber cells and grade 0 pain compared to the vehicle group[2][5].

• Resolution of Anterior Chamber Cells: Studies showed that 73% and 76% of patients treated with LOTEMAX SM achieved complete resolution of anterior chamber cells at day 8, significantly higher than the vehicle group[2].
• Pain Reduction: Similarly, a higher percentage of patients experienced grade 0 pain at day 8 with LOTEMAX SM compared to the vehicle group[2].

The safety profile of LOTEMAX SM is also favorable, with no treatment-emergent adverse drug reactions occurring in more than 1% of patients. Monitoring of intraocular pressure (IOP) is recommended if the product is used for 10 days or longer[2].

Market Forecast

The market for LOTEMAX SM is expected to grow significantly over the next decade. Here are some key points from the market forecast:

• Market Expansion: The market for postoperative pain and inflammation is set to expand due to extensive research and increased healthcare spending globally. This expansion will enable drug manufacturers to penetrate the market more effectively[1][4].
• Forecasted Sales: Detailed analyses of forecasted sales data from 2023 to 2032 indicate a positive trajectory for LOTEMAX SM. These forecasts will help clients in decision-making regarding their therapeutic portfolios[1][4].
• Competitive Landscape: The market will see competition from other emerging therapies, but LOTEMAX SM's advanced formulation and clinical efficacy are expected to maintain its market position. Late-stage emerging therapies will also impact the market, but LOTEMAX SM's current dominance is likely to continue[1][4].

Competitive Landscape

The competitive landscape for LOTEMAX SM includes both marketed therapies and late-stage emerging therapies.

• Marketed Therapies: LOTEMAX SM competes with other corticosteroids and anti-inflammatory agents used in postoperative care. However, its submicron particle size and enhanced ocular penetration give it a competitive edge[1][4].
• Late-stage Emerging Therapies: Several new therapies are in development, focusing on novel approaches to treat postoperative inflammation and pain. These therapies will provide competition but are not expected to immediately surpass LOTEMAX SM's market position[1][4].

Regulatory Milestones

LOTEMAX SM has achieved several regulatory milestones:

• FDA Approval: LOTEMAX SM was approved by the FDA in 2019 for the treatment of postoperative inflammation and pain following ocular surgery. The approval was based on adequate and well-controlled clinical trials[5].
• Developmental Activities: The drug has undergone extensive clinical trials, including Phase 3 studies, which have demonstrated its efficacy and safety. Regulatory submissions and approvals have been key in its market entry and expansion[1][4].

SWOT Analysis

A SWOT analysis provides a comprehensive view of LOTEMAX SM's market position:

• Strengths: Advanced submicron formulation, enhanced ocular penetration, and strong clinical efficacy data.
• Weaknesses: Potential for increased intraocular pressure if used for extended periods, and the need for ongoing monitoring.
• Opportunities: Growing market for postoperative care, increasing healthcare spending, and potential for use in a broader range of ocular surgeries.
• Threats: Emerging therapies and competition from other anti-inflammatory agents[1][4].

Analysts' Views

Analysts view LOTEMAX SM as a significant player in the postoperative care market:

• Market Dominance: Analysts expect LOTEMAX SM to maintain its market dominance due to its advanced formulation and strong clinical data[1][4].
• Future Prospects: The launch of late-stage emerging therapies will impact the market, but LOTEMAX SM's current position and ongoing research and development activities are expected to keep it competitive[1][4].

Financial Trajectory

The financial trajectory for LOTEMAX SM is positive, driven by several factors:

• Sales Growth: Forecasted sales data indicate a steady growth in revenue from 2023 to 2032, driven by increasing market demand and the drug's clinical efficacy[1][4].
• Market Penetration: The drug's ability to penetrate more into the market due to its advanced formulation and strong safety profile will contribute to its financial success[1][4].

Key Takeaways

• Clinical Efficacy: LOTEMAX SM has demonstrated strong clinical efficacy in treating postoperative inflammation and pain.
• Market Forecast: The market for LOTEMAX SM is expected to grow significantly over the next decade.
• Competitive Landscape: The drug faces competition from emerging therapies but maintains a competitive edge due to its advanced formulation.
• Regulatory Milestones: LOTEMAX SM has achieved significant regulatory milestones, including FDA approval.
• Financial Trajectory: The financial outlook for LOTEMAX SM is positive, driven by sales growth and market penetration.

FAQs

1. What is LOTEMAX SM used for? LOTEMAX SM is used for the treatment of postoperative inflammation and pain following ocular surgery.

2. What is the unique feature of LOTEMAX SM? LOTEMAX SM has a submicron particle size, which enhances its ocular penetration and residence time in anterior segment tissues.

3. How does LOTEMAX SM compare to other loteprednol etabonate formulations? LOTEMAX SM provides twice the penetration to the aqueous humor compared to LOTEMAX Gel 0.5% due to its smaller particle size[1].

4. What are the potential side effects of LOTEMAX SM? The most significant potential side effect is an increase in intraocular pressure if used for extended periods. Monitoring is recommended if the product is used for 10 days or longer[2].

5. What is the market outlook for LOTEMAX SM? The market outlook is positive, with forecasted sales growth from 2023 to 2032 driven by increasing demand and the drug's clinical efficacy[1][4].

Sources

1. GlobeNewswire: "United States LOTEMAX SM (Loteprednol Etabonate Ophthalmic Gel) Drug Insight and Market Forecast - 2032"[1].
2. LOTEMAX SM Official Website: "Proven Efficacy - LOTEMAX SM"[2].
3. GlobeNewswire: "United States LOTEMAX SM (Loteprednol Etabonate Ophthalmic Gel) Drug Market Insights and Forecast Report 2022-2032"[4].
4. FDA: "Summary Review - LOTEMAX SM (loteprednol etabonate ophthalmic gel), 0.38%"[5].