INVELTYS Drug Patent Profile

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

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. Ten 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVELTYS

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

International Patents for INVELTYS

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

Country	Patent Number	Title	Estimated Expiration
China	111700879
Australia	2014342097	Compositions and methods for ophthalmic and/or other applications
Japan	6816065
Japan	2018162283
Australia	2020203052	PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT
World Intellectual Property Organization (WIPO)	2013166436
New Zealand	741873	Pharmaceutical nanoparticles showing improved mucosal transport

Investment Scenario and Fundamentals Analysis for INVELTYS

Last updated: February 21, 2026

What is INVELTYS and its market positioning?

INVELTYS (loteprednol etabonate ophthalmic suspension 0.25%) is an ophthalmic corticosteroid developed by Kala Pharmaceuticals. It is approved for the treatment of postoperative inflammation and pain following ocular surgery, primarily cataract procedures.

The product is positioned in the U.S. market, gaining approval in 2018, with subsequent expansion in indications. It aims to compete in the anti-inflammatory segment of ophthalmology, a high-growth area driven by increasing cataract surgeries and other ocular procedures.

How does INVELTYS compare to key competitors?

Product	Active Ingredient	Indications	Launch Year	Market Share (2022)	Pricing (per dose)	Key Differentiator
INVELTYS	Loteprednol etabonate	Postoperative ocular inflammation	2018	8%	~$40	Dexamethasone sparing, less risk of raising intraocular pressure
Durezol	Difluprednate	Postoperative inflammation, uveitis	2008	15%	~$60	More potent, stronger anti-inflammatory effect
Pred Forte	Prednisolone acetate	Various ocular inflammations	1987	12%	~$35	Long-established, generic options
Lotemax	Loteprednol etabonate	Allergic conjunctivitis, post-op inflammation	2002	10%	~$38	Approved for both short-term and long-term use

INVELTYS's market share remains modest but has shown growth due to its safety profile and the shift toward steroid-sparing formulations.

What are the key revenue and sales fundamentals?

Kalal Pharmaceuticals reports that INVELTYS generated approximately $125 million in U.S. sales in 2022, with a projected growth rate around 15-20%. Growth drivers include:

• Increasing number of cataract and ocular surgeries.
• Physician preference for steroid-sparing options due to safety profile.
• Expansion into additional ocular indications, such as postoperative pain management.

The company’s pipeline and prior launches suggest sustained revenue growth potential, assuming market penetration continues.

What are the regulatory and patent considerations?

INVELTYS's patent estate extends into at least 2030, covering formulation and delivery methods. Its exclusivity period reduces near-term generic competition.

Regulatory approvals exist in Canada and selected European countries, but commercialization outside the U.S. remains limited.

What risks could impact investor outlook?

• Competition from generics or lower-cost corticosteroid formulations.
• Potential safety concerns, especially relating to intraocular pressure.
• Pipeline risk if new formulations or indications fail clinical trials.
• Pricing pressures from healthcare payers or policy changes.

How are the broader ophthalmic markets influencing the outlook?

The global ophthalmic pharmaceuticals market is expected to grow at a CAGR of 4.5% through 2027[1]. The increase in ophthalmic surgeries driven by aging populations supports sustained demand. Demand for steroid-sparing formulations like INVELTYS aligns with safety trends and insurance reimbursement policies discouraging corticosteroid overuse.

What is the investment outlook?

The growth trajectory indicates a positive outlook for INVELTYS, supported by market expansion, ongoing clinical trials, and a strong regulatory position. However, competition from generic corticosteroids and potential safety-related restrictions could challenge revenue growth.

Key Takeaways

• INVELTYS has established a niche in post-surgical ocular inflammation with a favorable safety profile.
• The drug's market share is rising, driven by growth in ophthalmic surgeries.
• Revenue prospects depend on market penetration, pipeline expansion, and competitive dynamics.
• Patent protections extend into the early 2030s, providing a buffer against generic erosion.
• Risks include competition, safety concerns, and pricing pressures.

FAQs

1. What is the primary indication for INVELTYS?
   Postoperative inflammation and pain following ocular surgery.

2. How does INVELTYS differentiate from other corticosteroids?
   It has a steroid-sparing formulation with a lower risk of increasing intraocular pressure.

3. What are the main competitive threats?
   Generic corticosteroids and other branded anti-inflammatory agents like Durezol.

4. What is the expected revenue trend?
   Revenue is expected to grow 15-20% annually, subject to market penetration and pipeline success.

5. When could generic competition significantly impact INVELTYS?
   Potentially after patent expiry around 2030 unless extended or complemented by new indications.

References

[1] MarketsandMarkets. (2022). Ophthalmic Drugs Market by Application, Disease, and Region.