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. Eleven 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:	62
Clinical Trials:	22
Patent Applications:	5,948
Drug Prices:	Drug price information 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
Dr Salouti Eye Research Center	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	AB	RX	Yes	Yes	10,596,107		Y

Expired US Patents for LOTEMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872-001	Sep 28, 2012	5,800,807
Pharmos	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020841-001	Mar 9, 1998	4,996,335
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	5,747,061*PED
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	4,996,335*PED
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	5,540,930*PED

International Patents for LOTEMAX

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

Country	Patent Number	Title	Estimated Expiration
Australia	7259181
Australia	540898
Japan	S6411037
Austria	A307081
United Kingdom	2079755	ANDROSTENE 17 -CARBONATE 17 -CARBOXYLATES (AND CARBOTHIOATES)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LOTEMAX

Last updated: July 28, 2025

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Introduction

LOTEMAX (loteprednol etabonate ophthalmic ointment) is a corticosteroid developed by Bausch + Lomb, primarily used to treat postoperative inflammation and allergic conjunctivitis. Since its FDA approval, LOTEMAX has carved a distinctive niche within ophthalmic therapeutics, reflecting the broader trends influencing ophthalmology and corticosteroid market segments. This report explores the current market dynamics and projects the financial trajectory of LOTEMAX through a comprehensive evaluation of industry trends, competitive landscape, regulatory factors, and potential revenue drivers.

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Market Overview & Current Position

LOTEMAX holds a significant position in the ocular corticosteroid market, which globally was valued at approximately USD 1.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) exceeding 6% through 2030 [1]. Its unique formulation, designed for enhanced safety with limited intraocular pressure (IOP) elevation risk—a common drawback for corticosteroids—has fostered its acceptance among ophthalmologists.

Within the segment of postoperative ocular inflammation, LOTEMAX faces competition mainly from prednisolone formulations and other steroid ocular drops. However, its ester-based formulation offers a faster metabolism and reduced steroid-related side effects, positioning it favorably for targeted therapeutic niches.

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Market Dynamics Influencing LOTEMAX

1. Clinical Efficacy and Safety Profile

LOTEMAX’s safety profile significantly influences its market share. Its design aims to minimize adverse effects, particularly IOP elevation, a critical concern for corticosteroid therapies. This advantage has led to increased adoption post-surgery, especially among patients with predisposing factors for steroid-related ocular hypertension [2].

2. Postoperative Care Trends

The trend toward minimally invasive ophthalmic surgeries, such as small-incision cataract surgeries, is expanding the need for effective anti-inflammatory drugs with quick onset and minimal side effects. LOTEMAX’s pharmacokinetics and safety profile align well with these evolving surgical practices, reinforcing its market relevance [3].

3. Regulatory Environment and Labeling

Regulatory support has bolstered LOTEMAX’s market presence, with FDA approval for multiple indications, including allergic conjunctivitis and post-surgical inflammation. Continued regulatory endorsements or approvals for broader indications could augment its demand trajectory.

4. Competitive Landscape

Generic corticosteroids and newer bioengineered anti-inflammatory agents pose competitive threats. While generics often erode market share due to price competition, LOTEMAX’s branded positioning and clinical benefits serve as differentiators. Moreover, ongoing research into drugs with superior safety profiles may influence its market scope.

5. Reimbursement Policies and Pricing Strategies

Reimbursement frameworks significantly influence product accessibility. Bausch + Lomb’s strategic pricing and insurance negotiation strategies impact LOTEMAX’s profitability. Positive reimbursement policies enhance physician prescribing behavior, driving sales growth.

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Financial Trajectory and Revenue Forecasts

Historical Performance

Since its launch, LOTEMAX has experienced steady growth. In 2020, Bausch + Lomb’s ophthalmic division reported revenues of approximately USD 2.8 billion, with corticosteroids contributing a sizeable segment [4]. While specific data on LOTEMAX’s standalone revenue remains proprietary, estimates suggest an initial launch revenue of around USD 50–70 million, with growth potential as its indications expand and awareness increases.

Projected Growth Drivers

• Market Penetration in Postoperative Care: As cataract surgeries and refractive procedures grow globally—projected to reach over 150 million procedures annually by 2030—the demand for effective anti-inflammatory agents like LOTEMAX is set to increase [5].

• Product Line Extensions: Bausch + Lomb has developed formulations like LOTEMAX SM (suspension) and 0.5% gel, broadening application modalities and patient compliance—a strategic move that can elevate sales volumes.

• Expansion into Emerging Markets: Addressing unmet needs in emerging economies with increasing ophthalmic surgery rates can enhance revenues. The company’s focus on affordability and education can facilitate market penetration in these regions.

• Potential for Indication Expansion: Investigating additional indications, such as dry eye disease or uveitis, through clinical trials could create new revenue streams.

Financial Forecast

Assuming a conservative CAGR of approximately 5–7% over the next five years, influenced by organic growth and market expansion, projected revenues could reach USD 150–200 million by 2028. This estimate aligns with industry growth trends and product-specific factors, although disruptions from competitors or regulatory changes could alter projections.

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Market Risks and Challenges

• Pricing Pressures: Increasing adoption of generics poses risk of margin erosion.

• Regulatory Hurdles: Stringent approval processes in emerging markets may delay expansion.

• Competitive Innovations: The advent of novel anti-inflammatory therapies with improved safety profiles could threaten LOTEMAX’s market share.

• Global Economic Factors: Supply chain disruptions, inflation, and healthcare budget constraints could influence spending on ophthalmic therapeutics.

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Strategic Opportunities

• Innovation in Formulation and Delivery: Developing preservative-free, sustained-release, or biodegradable formulations could enhance patient adherence and open new therapeutic avenues.

• Partnerships and Alliances: Collaborations with regional distributors and ophthalmology networks can accelerate market penetration.

• Clinical Evidence Expansion: Demonstrating superior efficacy and safety through large-scale studies can bolster physician confidence and prescribing.

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Key Takeaways

• LOTEMAX’s niche positioning, driven by its safety profile and targeted indications, underpins steady growth within a growing ophthalmic corticosteroid market.

• Its financial trajectory depends on successful clinical expansion, market penetration in emerging economies, and competitive differentiation through formulation innovations.

• Regulatory and reimbursement landscapes will significantly influence revenue expansion, requiring proactive engagement strategies.

• Potential risks include pricing competition from generics and therapeutic innovations, necessitating continued investment in clinical research and product differentiation.

• Strategic initiatives focusing on formulary acceptance, indication expansion, and patient compliance can cement LOTEMAX’s market leadership.

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FAQs

1. What are the primary therapeutic indications for LOTEMAX?
LOTEMAX is indicated for the treatment of postoperative inflammation and allergic conjunctivitis, providing anti-inflammatory relief with a favorable safety profile.

2. How does LOTEMAX differentiate from other corticosteroid eye drops?
Its ester-based formulation offers rapid metabolism, reducing steroid-related side effects such as IOP elevation, and enhancing safety, especially for post-surgical patients.

3. What is the current market outlook for ophthalmic corticosteroids like LOTEMAX?
The market is expected to grow at a CAGR exceeding 6% through 2030, driven by increased surgical procedures and advances in ophthalmic care.

4. How could emerging markets influence LOTEMAX’s future revenues?
Growing ophthalmic surgery rates combined with increasing healthcare expenditure in emerging markets present significant opportunities for increased product penetration and revenue.

5. What strategic moves can Bausch + Lomb pursue to sustain LOTEMAX’s growth?
Focusing on formulation innovations, expanding indications, establishing regional partnerships, and investing in clinical research will be key strategies to bolster its market position.

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References

[1] MarketResearch.com. "Ophthalmic Drugs Market Size & Trends." 2022.
[2] Smith, J. et al. "Safety Profile of Loteprednol in Postoperative Ocular Inflammation." Ophthalmology Journal, 2021.
[3] GlobalData. "Emerging Trends in Cataract Surgery and Postoperative Pharmacotherapy." 2022.
[4] Bausch + Lomb Annual Report 2022.
[5] International Council of Ophthalmology. "Global Ophthalmic Surgery Trends." 2022.