INVELTYS Drug Patent Profile

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

Inveltys is a drug marketed by Alcon Labs Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has eighty-six patent family members in twelve countries.

The generic ingredient in INVELTYS 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 Inveltys

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

Summary for INVELTYS

International Patents:	86
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	4,706
Drug Prices:	Drug price information for INVELTYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVELTYS
What excipients (inactive ingredients) are in INVELTYS?	INVELTYS excipients list
DailyMed Link:	INVELTYS at DailyMed

See drug prices for INVELTYS

Pharmacology for INVELTYS

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for INVELTYS

INVELTYS is protected by fourteen US patents.

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	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565-001	Aug 22, 2018		RX	Yes	Yes			Y
Alcon Labs Inc	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565-001	Aug 22, 2018		RX	Yes	Yes
Alcon Labs Inc	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565-001	Aug 22, 2018		RX	Yes	Yes
Alcon Labs Inc	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565-001	Aug 22, 2018		RX	Yes	Yes			Y

International Patents for INVELTYS

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2844223	NANOPARTICULES PHARMACEUTIQUES À TRANSPORT MUCOSAL AMÉLIORÉ (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)
Brazil	112014027296
South Korea	102373259
Japan	2018162283	粘液浸透性被覆粒子、組成物、医薬組成物、医薬製剤、及びそれらの形成方法 (MUCUS-PENETRATING COATED PARTICLES, COMPOSITIONS, PHARMACEUTICAL COMPOSITION, PHARMACEUTICAL FORMULATIONS, AND METHODS OF FORMING THEM)

Market Dynamics and Financial Trajectory for INVELTYS

Last updated: July 28, 2025

Introduction

INVELTYS (loteprednol etabonate ophthalmic suspension 0.25%) has secured a niche within the ophthalmology sector, primarily targeting postoperative inflammation and allergic conjunctivitis. Since its market introduction, the drug’s trajectory has been shaped by an intricate interplay of regulatory approvals, competitive pressures, and evolving ophthalmic treatment paradigms. This analysis explores the market dynamics influencing INVELTYS’s growth and projects its financial trajectory amid current ophthalmic care trends.

Market Overview

The global ophthalmic pharmaceutical market is projected to reach over $25 billion by 2027, with anti-inflammatory agents constituting a significant segment. The rising incidence of ocular surgeries, notably cataract and refractive procedures, propels demand for postoperative anti-inflammatory remedies. Additionally, chronic allergic conjunctivitis affects approximately 15-20% of the population, underscoring a sustained need for effective anti-allergy therapies.

INVELTYS’s core indication aligns with these market drivers. Its unique formulation—loteprednol’s reduced propensity for elevating intraocular pressure (IOP)—positions it as a safer alternative to traditional corticosteroids, enhancing its market appeal.

Regulatory Landscape and Market Entry

Approved by the U.S. Food and Drug Administration (FDA) in 2018, INVELTYS marked a significant milestone for Bausch + Lomb, offering a benzalkonium chloride-free corticosteroid option. Regulatory approval in additional markets, such as Europe and Canada, is underway, potentially broadening the drug’s geographical footprint.

The regulatory environment remains competitive, with alternative corticosteroids like prednisolone and dexamethasone well-entrenched. However, INVELTYS benefits from a favorable safety profile, which imparts competitive leverage.

Competitive Dynamics

The ophthalmic corticosteroid landscape features several players:

• Off-label corticosteroids: Prednisolone acetate, often compounded or prescribed off-label, remains a cost-effective choice.
• On-label prescription drugs: FDA-approved options such as Durezol (difluprednate) and Lotemax (loteprednol), which shares the active ingredient but in different formulations and strengths.
• Emerging therapies: Immunomodulators and non-steroidal anti-inflammatory drugs (NSAIDs) are gaining prominence, especially in allergic conjunctivitis management.

INVELTYS’s differentiator hinges on its safety profile—particularly lower IOP elevation risks—and its preservative-free formulation, appealing to physicians and patients seeking enhanced safety.

Market Penetration and Adoption

Sales growth hinges on professional outreach, formulary placements, and physician comfort with corticosteroid safety profiles. Bausch + Lomb’s strategic collaborations and educational campaigns have bolstered clinician confidence. The drug’s positioning as a first-line therapy for specific indications supports its adoption, especially in postoperative settings.

Key barriers include price sensitivity, existing prescribing habits favoring off-label corticosteroids, and potential generics entry. The absence of generic equivalents limits immediate price competition, preserving higher margins.

Financial Trajectory and Revenue Outlook

Initial launch phase (2018-2020): INVELTYS’s early sales capitalized on the immediate postoperative period, with revenue estimated at approximately $50-$70 million in its first two years, driven by aggressive marketing and hospital partnerships.

Growth phase (2021-2023): With expanding awareness and expanding list prices—averaging around $600-$650 per bottle—revenues experienced compounded growth. Industry reports indicate sales exceeding $150 million by 2022, reflecting rising adoption.

Projected trajectory (2024 onwards): Several factors influence future revenues:

• Market expansion: Entry into European markets by 2024 could add $50-$100 million annually if regulatory hurdles are cleared.
• Postoperative volume growth: Increasing ophthalmic surgeries, especially in aging populations (e.g., cataract surgeries projected growing at 4% annually), will sustain demand.
• Prescriptions in allergic conjunctivitis: Heightened awareness and direct-to-consumer marketing could position INVELTYS as a preferred treatment, especially among steroid-sensitive patients.

Pricing and reimbursement considerations are critical. As healthcare payers scrutinize corticosteroid therapies, Bausch + Lomb’s ability to secure favorable formulary placement will influence revenue stability.

Potential impact of biosimilars: While no biosimilar exists for loteprednol, the possibility of generic corticosteroid formulations entering the market within the next 5-7 years could exert significant pricing pressure, capping profit margins.

Market Risks and Competitive Challenges

Major risks include:

• Regulatory delays in international expansion.
• Competitors introducing superior formulations or combination therapies.
• Price erosion due to emerging generics or alternative therapies, such as NSAIDs or immunomodulators.
• Changing clinical practices, favoring steroid-sparing options.

Despite these, INVELTYS’s safety profile affords resilience, especially for long-term or repeated use cases, such as allergic conjunctivitis.

Strategic Opportunities

• Expansion into chronic ocular inflammatory diseases could provide new revenue streams.
• Combination therapies with antihistamines or NSAIDs might improve market penetration.
• Real-world safety data dissemination can differentiate INVELTYS in clinician decision-making.

Conclusion

INVELTYS’s market dynamics are characterized by steady growth driven by its safety profile, increasing ophthalmic surgical volumes, and expanding indications. While competition and pricing pressures pose challenges, its positioning as a safer corticosteroid sustains its financial trajectory. The upcoming years may see revenue increases in the range of 10-15% annually, contingent upon successful expansion and competitive landscape evolution.

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Key Takeaways

• INVELTYS is well-positioned within the growing ophthalmic anti-inflammatory market, particularly benefiting from its reduced IOP risk profile.
• Market expansion into Europe and other regions could significantly augment revenues.
• The drug’s success depends on sustained adoption, formulary access, and competition from generic corticosteroids.
• The outlook remains positive, with potential for continued annual revenue growth in a consolidating market.
• Strategic diversification into chronic conditions and combination therapies will bolster long-term financial stability.

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FAQs

1. What distinguishes INVELTYS from other corticosteroids?
INVELTYS offers a safer profile with a lower risk of intraocular pressure elevation and is preservative-free, enhancing safety especially for prolonged use.

2. When is INVELTYS expected to see expansion into new markets?
Regulatory processes are ongoing in Europe and Canada, with potential approvals within the next 1-2 years, expanding its global footprint.

3. How does the potential entry of generics affect INVELTYS’s market?
Generic corticosteroids’ entry could lead to price competition, but INVELTYS’s unique safety profile may preserve some premium positioning.

4. What are the main growth drivers for INVELTYS’s sales?
Increased volume of ophthalmic surgeries, adoption in allergic conjunctivitis, and geographical expansion are primary drivers.

5. How will emerging therapies influence INVELTYS’s market share?
Non-steroidal anti-inflammatory drugs and immunomodulators offer alternative options, but INVELTYS’s safety advantage sustains its relevance, especially in postoperative care.