DEXYCU KIT Drug Patent Profile

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

Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. There are five patents protecting this drug.

This drug has forty-six patent family members in twenty-two countries.

The generic ingredient in DEXYCU KIT is dexamethasone. There are thirty-nine drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dexycu Kit

A generic version of DEXYCU KIT was approved as dexamethasone by HIKMA on September 15^th, 1983.

Summary for DEXYCU KIT

International Patents:	46
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	10
Patent Applications:	2,399
DailyMed Link:	DEXYCU KIT at DailyMed

Recent Clinical Trials for DEXYCU KIT

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

Sponsor	Phase
EyePoint Pharmaceuticals, Inc.	Phase 3
Karyopharm Therapeutics Inc	Phase 2
University of Miami	Phase 2

See all DEXYCU KIT clinical trials

US Patents and Regulatory Information for DEXYCU KIT

DEXYCU KIT is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes			Y
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes			Y
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes			Y

Expired US Patents for DEXYCU KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018

EU/EMA Drug Approvals for DEXYCU KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Ozurdex	dexamethasone	EMEA/H/C/001140 Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.	Authorised	no	no	no	2010-07-26
THERAVIA	Neofordex	dexamethasone	EMEA/H/C/004071 Treatment of multiple myeloma.	Authorised	no	no	no	2016-03-16

International Patents for DEXYCU KIT

See the table below for patents covering DEXYCU KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019218870
China	111757764
European Patent Office	2701773
Poland	2701773
South Korea	101978235
Spain	2726805

Supplementary Protection Certificates for DEXYCU KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003

Market Dynamics and Financial Trajectory for DEXYCU

Introduction to DEXYCU

DEXYCU, or dexamethasone intraocular suspension 9%, is a groundbreaking ophthalmic product developed by EyePoint Pharmaceuticals. It is the first long-acting intraocular steroid approved by the FDA for the treatment of postoperative inflammation following ocular surgery, such as cataract surgery[1].

Market Need and Target Audience

The market for DEXYCU is significant, given the high volume of cataract surgeries performed annually. In the United States alone, approximately 4.8 million cataract surgeries are conducted each year, creating a substantial demand for effective postoperative inflammation treatments[1].

Commercial Launch and Distribution

The commercial launch of DEXYCU was phased, initially targeting leading cataract surgery experts to ensure proper training on its administration. This strategic approach aimed to build a strong foundation for wider adoption within the ophthalmology community[1].

Expanded Commercial Alliance

EyePoint Pharmaceuticals has strengthened its market presence through an expanded commercial alliance with ImprimisRx. Under this agreement, ImprimisRx assumed full responsibility for the U.S. sales and marketing activities of DEXYCU, leveraging their expertise in ocular and cataract surgery. This partnership allows EyePoint to focus on advancing its retinal disease-focused pipeline while benefiting from ImprimisRx’s extensive network and marketing capabilities[4].

Financial Performance

Revenue and Sales

In the fourth quarter of 2022, EyePoint Pharmaceuticals reported total net revenue of $10.5 million, with net product revenue of $9.9 million. For the full year 2022, total net revenue was $41.4 million, with net product revenue of $39.9 million. While these figures indicate a steady revenue stream, they also reflect the challenges faced by the company, including a decline in sales and marketing expenses for DEXYCU due to the loss of pass-through reimbursement by CMS effective January 1, 2023[2].

Operating Expenses and Impairment Charges

The company's operating expenses increased significantly in 2022, primarily due to a one-time $20.7 million non-cash impairment charge associated with DEXYCU. This charge was a result of the loss of pass-through reimbursement status by CMS. Additionally, there were increases in R&D expenses and general and administrative costs, which were partially offset by decreases in sales and marketing expenses[2].

Net Loss and Cash Position

EyePoint Pharmaceuticals reported a net loss of $43.5 million for the fourth quarter of 2022 and $102.3 million for the full year. Despite these losses, the company maintained a cash, cash equivalents, and investments position of $144.6 million as of December 31, 2022. This financial cushion is expected to support the company's operations into the second half of 2024[2].

Impact of Regulatory Changes

The loss of pass-through reimbursement status for DEXYCU by CMS has had a significant impact on EyePoint's financial trajectory. This change led to a substantial impairment charge and is expected to influence the product's commercial performance moving forward. The company is adapting by focusing on other revenue streams and optimizing its sales and marketing strategies[2][3].

Research and Development

EyePoint Pharmaceuticals continues to invest heavily in research and development, particularly in its pipeline product EYP-1901, which is being evaluated for wet age-related macular degeneration and non-proliferative diabetic retinopathy. These efforts are crucial for the company's long-term growth and diversification beyond DEXYCU[3].

Market Acceptance and Competition

DEXYCU has been well-received by ophthalmologists due to its sustained release treatment benefits, which complement traditional eye drop regimens. However, the product faces competition in the ophthalmic market, and its success is also dependent on market acceptance and the effectiveness of the expanded commercial alliance with ImprimisRx[4].

Future Outlook

EyePoint Pharmaceuticals anticipates continued investment in R&D and expects to fund its operations through a combination of product sales, licensing agreements, and potential equity raises. The company believes its current cash position will suffice for at least the next twelve months, allowing it to pursue its strategic goals, including the growth of DEXYCU and the advancement of its pipeline products[2][5].

Key Takeaways

• Market Need: DEXYCU addresses a significant market need for postoperative inflammation treatment in ocular surgery.
• Commercial Strategy: The product's commercial success is bolstered by an expanded alliance with ImprimisRx.
• Financial Performance: Despite revenue growth, the company faces challenges due to regulatory changes and increased operating expenses.
• Research and Development: Continued investment in R&D is crucial for long-term growth.
• Market Acceptance: DEXYCU has been well-received, but its success depends on ongoing market acceptance and competitive dynamics.

Frequently Asked Questions (FAQs)

What is DEXYCU used for?

DEXYCU is used for the intraocular treatment of postoperative inflammation following ocular surgery, such as cataract surgery.

Who is responsible for the sales and marketing of DEXYCU in the U.S.?

ImprimisRx is responsible for the U.S. sales and marketing activities of DEXYCU under an expanded commercial alliance with EyePoint Pharmaceuticals.

How has the loss of pass-through reimbursement affected DEXYCU's financial performance?

The loss of pass-through reimbursement by CMS led to a significant non-cash impairment charge and has impacted the product's commercial performance, necessitating adjustments in sales and marketing strategies.

What are the key financial challenges faced by EyePoint Pharmaceuticals regarding DEXYCU?

The key financial challenges include increased operating expenses, a significant impairment charge due to the loss of pass-through reimbursement, and the need to maintain a strong cash position to support ongoing operations.

What is the current outlook for EyePoint Pharmaceuticals' cash position and funding needs?

EyePoint Pharmaceuticals expects its current cash, cash equivalents, and investments to suffice for at least the next twelve months, with plans to continue funding operations through product sales, licensing agreements, and potential equity raises.

Cited Sources:

1. EyePoint Pharmaceuticals Announces U.S. Commercial Launch of DEXYCU - EyePoint Pharmaceuticals, Inc.
2. EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2022 Financial Results and Highlights Recent Corporate Developments - BioSpace
3. EyePoint Pharmaceuticals Reports First Quarter 2023 Financial Results and Highlights Recent Corporate Developments - EyePoint Pharmaceuticals, Inc.
4. EyePoint Pharmaceuticals, ImprimisRx announce expanded commercial alliance for DEXYCU - Ophthalmology Times
5. Form 10-Q for Eyepoint Pharmaceuticals INC filed 05/09/2024 - EyePoint Pharmaceuticals, Inc.