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-four patent family members in twelve countries.

The generic ingredient in INVELTYS 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 Inveltys

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

Summary for INVELTYS

International Patents:	84
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	4,594
Drug Prices:	Drug price information 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

International Patents for INVELTYS

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

Country	Patent Number	Title	Estimated Expiration
Chile	2019003433	Composición farmacéutica oftálmica que comprende nanopartículas mucopenetrantes, cuyo núcleo comprende un agente activo farmacéutico seleccionado entre un inhibidor de receptor tirosina quinasa (rtk), o un inhibidor de la angiogénesis, y está recubierto con un polímero modificador de superficie; y uso para tratar un trastorno del ojo (divisional de solicitud cl 2956-2014).
Japan	6816064
Australia	2018201215	Pharmaceutical nanoparticles showing improved mucosal transport

Market Dynamics and Financial Trajectory for INVELTYS

Overview of INVELTYS

INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a nanoparticle ocular corticosteroid formulation developed by Kala Pharmaceuticals. It is approved by the FDA for the treatment of post-operative inflammation and pain following ocular surgery[1][4].

Market Assessment

Clinical and Regulatory Context

INVELTYS is contraindicated in certain ocular conditions, including viral diseases of the cornea and conjunctiva, mycobacterial infections, and fungal diseases of ocular structures. Despite these limitations, it has a favorable profile for treating post-operative ocular inflammation and pain[4].

Market Trends

The market for post-operative ocular inflammation and pain has seen significant changes. The COVID-19 pandemic led to a reduction in ocular surgeries, which impacted INVELTYS prescriptions. However, as surgical volumes returned to pre-pandemic levels, the market has become increasingly competitive with a shift towards generic alternatives, affecting the branded market negatively[1].

Financial Performance

Quarterly and Annual Revenue

• In the first quarter of 2022, INVELTYS generated $0.4 million in net revenue, down from $1.6 million in the same period of 2021. This decline was partly due to increased competition from generics and reduced ocular surgeries during the pandemic[1].
• For the second quarter of 2022, INVELTYS sales contributed $1.2 million to the net product revenues, compared to $1.4 million in the same period of 2021[2].
• For the full year 2021, INVELTYS sales yielded $4.9 million in net revenue, a decrease from $6.1 million in 2020, primarily due to increased product returns[5].

Prescription Volume

Despite the revenue decline, the number of prescriptions for INVELTYS remained significant. In the first quarter of 2022, 34,691 INVELTYS prescriptions were reported, although this was lower than the 36,695 prescriptions in the fourth quarter of 2021[1].

Cost and Expenses

Cost of Product Revenues

The cost of product revenues for INVELTYS has been relatively stable. For the first quarter of 2022, the cost of product revenues was $0.8 million, consistent with the same period in 2021. For the second quarter of 2022, it increased to $1.8 million, up from $1.0 million in the same period of 2021[1][2].

Selling, General, and Administrative (SG&A) Expenses

SG&A expenses have been a significant component of Kala Pharmaceuticals' financials. For the second quarter of 2022, SG&A expenses were $22.7 million, reflecting ongoing efforts in marketing, sales, and administrative activities[2].

Market Outlook and Future Prospects

Expansion of Coverage

Kala Pharmaceuticals has been working to expand formulary coverage for INVELTYS. Increased Medicare Part D coverage is expected to boost INVELTYS prescriptions and revenues in the future[1].

Competitive Landscape

The market for acute ocular pain is becoming increasingly competitive with the emergence of new therapies. INVELTYS faces competition from both existing and late-stage emerging therapies, which could impact its market share and revenue growth[4].

Forecasted Sales

The market forecast for INVELTYS from 2023 to 2032 indicates that while the drug will continue to have a presence in the market, its sales will be influenced by the launch of new therapies and changing market dynamics. The report from ResearchAndMarkets.com provides a detailed analysis of the forecasted sales data, which will help in understanding the future market scenario for INVELTYS[4].

Key Takeaways

• Revenue Trends: INVELTYS has seen a decline in revenue due to increased competition from generics and the impact of the COVID-19 pandemic on ocular surgeries.
• Prescription Volume: Despite revenue declines, the number of INVELTYS prescriptions remains significant.
• Cost and Expenses: The cost of product revenues has been relatively stable, while SG&A expenses continue to be substantial.
• Market Outlook: The expansion of Medicare Part D coverage and ongoing market dynamics will influence INVELTYS's future prospects.
• Competitive Landscape: The emergence of new therapies will continue to pose a challenge to INVELTYS's market dominance.

FAQs

1. What is INVELTYS used for? INVELTYS is used for the treatment of post-operative inflammation and pain following ocular surgery[4].

2. How has the COVID-19 pandemic affected INVELTYS sales? The pandemic led to a reduction in ocular surgeries, which negatively impacted INVELTYS prescriptions and revenues[1].

3. What are the main challenges facing INVELTYS in the market? The main challenges include increased competition from generic alternatives and the emergence of new therapies for acute ocular pain[4].

4. How is Kala Pharmaceuticals addressing the decline in INVELTYS revenue? Kala is working to expand formulary coverage, including increased Medicare Part D coverage, to boost INVELTYS prescriptions and revenues[1].

5. What is the forecasted market scenario for INVELTYS from 2023 to 2032? The market forecast indicates that INVELTYS will face competition from new therapies, but it will continue to have a presence in the market. Detailed forecasted sales data is available in market analysis reports[4].

Sources

1. Kala Reports First Quarter 2022 Financial Results and Provides Corporate Update - Kala Pharmaceuticals[1]
2. Kala Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update - GlobeNewswire[2]
3. 2023 Annual Report - [PDF] Kala Pharmaceuticals[3]
4. INVELTYS Drug Insight and Market Forecast - 2032 - ResearchAndMarkets.com[4]
5. Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update - GlobeNewswire[5]