LOTEPREDNOL ETABONATE - Generic Drug Details

What are the generic drug sources for loteprednol etabonate and what is the scope of freedom to operate?

Loteprednol etabonate is the generic ingredient in seven branded drugs marketed by Bausch And Lomb Inc, Hikma, Sentiss, Sun Pharm, Bausch And Lomb, Alcon Labs Inc, Pharmos, Lupin Ltd, and Padagis Us, and is included in eighteen NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loteprednol etabonate has one hundred and fourteen patent family members in sixteen countries.

There are ten drug master file entries for loteprednol etabonate. Eight suppliers are listed for this compound.

Summary for LOTEPREDNOL ETABONATE

International Patents:	114
US Patents:	21
Tradenames:	7
Applicants:	9
NDAs:	18
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	47
Patent Applications:	5,966
Drug Prices:	Drug price trends for LOTEPREDNOL ETABONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOTEPREDNOL ETABONATE
What excipients (inactive ingredients) are in LOTEPREDNOL ETABONATE?	LOTEPREDNOL ETABONATE excipients list
DailyMed Link:	LOTEPREDNOL ETABONATE at DailyMed

See drug prices for LOTEPREDNOL ETABONATE

Recent Clinical Trials for LOTEPREDNOL ETABONATE

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

Sponsor	Phase
Kala Pharmaceuticals, Inc.	Phase 4
Price Vision Group	Phase 4
Thomas Chester, OD	Phase 4

See all LOTEPREDNOL ETABONATE clinical trials

Pharmacology for LOTEPREDNOL ETABONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for LOTEPREDNOL ETABONATE

Anti-Allergic Agents

Anatomical Therapeutic Chemical (ATC) Classes for LOTEPREDNOL ETABONATE

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LOTEPREDNOL ETABONATE

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 LOTEPREDNOL ETABONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Hikma	LOTEPREDNOL ETABONATE	loteprednol etabonate	GEL;OPHTHALMIC	213956-001	Nov 29, 2023		DISCN	No	No
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes

Expired US Patents for LOTEPREDNOL ETABONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998
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
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 LOTEPREDNOL ETABONATE

Country	Patent Number	Title	Estimated Expiration
Chile	2014002956	Composicion farmaceutica ocular que comprende particulas recubiertas de dimension menor a 1 micron, con un nucleo que comprende etaboato de loteprednol y un recubrimiento con modificadores de superficie; y uso para tratar la inflamacion, degeneracion macular, edema macular u otro trastorno del ojo.
South Korea	102154880
Hong Kong	1208382	顯示提高的粘膜轉移的藥物納米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)
Japan	2022017589	複数の被覆された粒子を含む組成物、医薬組成物、医薬製剤、及び当該粒子の形成方法
Australia	2013256130	Pharmaceutical nanoparticles showing improved mucosal transport

LOTEPREDNOL ETABONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Loteprednol Etabonate

Introduction to Loteprednol Etabonate

Loteprednol etabonate is a corticosteroid medication primarily used to treat eye inflammation, dry eye disease (DED), and post-surgical ophthalmic conditions. Its market dynamics are influenced by several key factors, including therapeutic applications, market segmentation, and the competitive landscape.

Market Size and Growth Projections

The global Loteprednol Etabonate market has been experiencing significant growth. As of 2023, the market size is estimated to be around USD 1.2 billion, with projections indicating it will reach approximately USD 2.3 billion by 2031[4].

Segments and Applications

The market is segmented based on type (patented drug, generic drug), application (hospital, drug store, online), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

• Type: The market includes both patented and generic versions of loteprednol etabonate. The expiration of exclusivity for certain formulations has opened up opportunities for generic drug manufacturers[2].
• Application: The drug is used in various settings, including hospitals, drug stores, and online platforms. Hospitals and specialized ophthalmic treatment providers are significant end-users[3].
• Geography: The market is spread across multiple regions, with North America and Europe being key markets due to high prevalence rates of ophthalmic disorders and advanced healthcare infrastructure.

Market Drivers

Several factors are driving the growth of the loteprednol etabonate market:

• Rising Prevalence of Ophthalmic Disorders: The increasing incidence of dry eye disease and other ophthalmic conditions, particularly among the geriatric population, is a significant driver[3].
• Advancements in Drug Delivery Systems: Innovations in drug formulations, such as gels, ointments, and suspensions, have improved the efficacy and patient compliance of loteprednol etabonate[3].
• Growing Awareness of Eye Health: Increased awareness about eye health and the importance of treating ophthalmic conditions has led to higher demand for loteprednol etabonate[3].

Market Restraints

Despite the growth, there are several challenges facing the market:

• Regulatory and Patent Issues: The expiration of patents and regulatory approvals can impact the market dynamics. For instance, Akorn's voluntary recall of loteprednol etabonate products due to quality control issues has affected market stability[2].
• Competition from Generic Drugs: The entry of generic versions can reduce the market share of branded products, as seen with INVELTYS prescriptions impacted by the rise of generic alternatives[5].
• Quality Control and Storage: Ensuring consistent product quality and addressing concerns related to long-term shelf-life and storage conditions are critical challenges[3].

Market Opportunities

There are several opportunities for growth and innovation in the loteprednol etabonate market:

• Personalized Treatment Regimens: Developing patient-specific treatment plans can enhance the efficacy of loteprednol etabonate and improve patient outcomes[3].
• Cost-Effective Formulations: Creating more affordable formulations can increase accessibility for a broader patient base, particularly in regions with limited healthcare resources[3].
• Targeted Marketing: Enhancing visibility through targeted marketing campaigns and professional medical conferences can increase adoption rates among healthcare providers[3].

Competitive Landscape

The competitive landscape of the loteprednol etabonate market is dynamic, with several key players:

• Bausch + Lomb: Known for their branded products Lotemax and Loterex, Bausch + Lomb has a significant market presence[2].
• Kala Pharmaceuticals: Kala has seen growth with their products EYSUVIS and INVELTYS, with EYSUVIS prescriptions showing quarter-over-quarter growth[5].
• Akorn: Despite recent challenges, Akorn has been a player in the generic loteprednol etabonate market[2].
• Sun Pharmaceutical: Sun Pharmaceutical is another major player, contributing to the market's competitive dynamics[1].

Financial Performance

The financial performance of companies involved in the loteprednol etabonate market reflects the market's growth and challenges:

• Kala Pharmaceuticals: In the first quarter of 2022, Kala reported net product revenues of $1.4 million, with $1.0 million from EYSUVIS sales and $0.4 million from INVELTYS sales. However, the company faced an operating loss of $30.9 million during the same period[5].
• Generic Market Impact: The entry of generic drugs has impacted the revenue of branded products. For instance, INVELTYS prescriptions have been affected by the rise of generic alternatives[5].

PESTLE Analysis

A PESTLE analysis provides insights into the external macro-environmental factors influencing the market:

• Political: Regulatory changes and patent laws significantly impact the market.
• Economic: Economic conditions, such as healthcare spending and insurance coverage, influence market growth.
• Social: Growing awareness of eye health and increasing geriatric populations drive demand.
• Technological: Advancements in drug delivery systems and manufacturing processes are crucial.
• Legal: Patent expirations and regulatory approvals are key factors.
• Environmental: Storage and shelf-life concerns are important environmental considerations[3].

Key Takeaways

• The loteprednol etabonate market is poised for significant growth driven by rising ophthalmic disorders and advancements in drug delivery.
• Generic versions are entering the market, changing the competitive landscape.
• Companies must focus on cost-effective formulations, personalized treatment regimens, and targeted marketing to maintain market share.
• Regulatory and quality control issues are critical challenges that need to be addressed.

FAQs

What is the current market size of the loteprednol etabonate market?

The global loteprednol etabonate market size is estimated to be around USD 1.2 billion as of 2023[4].

Which companies are major players in the loteprednol etabonate market?

Major players include Bausch + Lomb, Kala Pharmaceuticals, Akorn, Sun Pharmaceutical, and Cipla[1][3].

What are the primary drivers of the loteprednol etabonate market?

The primary drivers include the rising prevalence of ophthalmic disorders, advancements in drug delivery systems, and growing awareness of eye health[3].

How has the expiration of patents impacted the market?

The expiration of patents has opened up opportunities for generic drug manufacturers, leading to increased competition and potential changes in market dynamics[2].

What are the key challenges facing the loteprednol etabonate market?

Key challenges include regulatory and patent issues, competition from generic drugs, and concerns related to quality control and storage[2][3].

Cited Sources

1. Market Research Intellect - Global Loteprednol Etabonate Market Size, Trends and Projections[1]
2. GreyB - Loteprednol etabonate generic drug has transformational potential[2]
3. 360iResearch - Loteprednol Etabonate Ophthalmic Drugs Market Size 2025-2030[3]
4. DataIntelo - Loteprednol Etabonate Market Research Report 2032[4]
5. Kala Pharmaceuticals - Kala Reports First Quarter 2022 Financial Results and Provides Business Update[5]