DEXTENZA Drug Patent Profile

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

Dextenza is a drug marketed by Ocular Therapeutix and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in DEXTENZA 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 Dextenza

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

Summary for DEXTENZA

International Patents:	24
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	45
Patent Applications:	3,683
Drug Prices:	Drug price information for DEXTENZA
What excipients (inactive ingredients) are in DEXTENZA?	DEXTENZA excipients list
DailyMed Link:	DEXTENZA at DailyMed

See drug prices for DEXTENZA

Recent Clinical Trials for DEXTENZA

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

Sponsor	Phase
Wyse Eyecare	Phase 4
Duke University	Early Phase 1
Navy Medical Center San Diego	Phase 4

See all DEXTENZA clinical trials

Pharmacology for DEXTENZA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for DEXTENZA

DEXTENZA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes			Y
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes

Expired US Patents for DEXTENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018

EU/EMA Drug Approvals for DEXTENZA

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 DEXTENZA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2016201869	Biomaterials for track and puncture closure
Canada	2977830	BIOMATERIAUX POUR LA FERMETURE DE VOIE ET DE PONCTION (BIOMATERIALS FOR TRACK AND PUNCTURE CLOSURE)
European Patent Office	1104286
Japan	5684239
World Intellectual Property Organization (WIPO)	2017062770

Supplementary Protection Certificates for DEXTENZA

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 DEXTENZA

Introduction to DEXTENZA

DEXTENZA, developed by Ocular Therapeutix, is an innovative drug designed to treat acute ocular pain and inflammation following ophthalmic surgery. It is a preservative-free, resorbable intracanalicular insert that releases dexamethasone, a potent corticosteroid, over a period of up to 30 days.

Mechanism of Action and Clinical Development

DEXTENZA works by releasing dexamethasone directly into the canalicular space of the eye, providing localized anti-inflammatory and analgesic effects. This mechanism is crucial for managing postoperative pain and inflammation without the need for topical eye drops, which can be cumbersome for patients[4].

The clinical development of DEXTENZA has been robust, with several clinical trials demonstrating its safety and efficacy in treating post-surgical ocular pain. These trials have shown that DEXTENZA significantly reduces the need for postoperative pain medications and improves patient outcomes[4].

Market Outlook

Current Market Performance

As of the second quarter of 2024, DEXTENZA has shown significant growth in its market performance. The net product revenue for DEXTENZA increased by 8.3% compared to the same period in 2023, reaching $16.4 million. This growth is attributed to increased sales and a revised pricing and discounting strategy implemented in Q3 2022[2].

For the full year 2024, Ocular Therapeutix expects total net revenues for DEXTENZA to be between $62.0 million and $67.0 million, indicating a continued upward trend in sales[2].

Future Market Projections

The market forecast for DEXTENZA is optimistic, with projected sales expected to grow steadily until 2032. The report from ResearchAndMarkets.com forecasts that the market scenario for postoperative pain, where DEXTENZA is a key player, will expand due to extensive research and increased healthcare spending globally. This expansion is expected to enable drug manufacturers, including Ocular Therapeutix, to penetrate the market more effectively[1][4].

Competitive Landscape

The competitive landscape for DEXTENZA includes both marketed therapies and late-stage emerging therapies. While DEXTENZA currently holds a significant market share, other emerging products are expected to provide tough competition. The launch of late-stage emerging therapies in the near future will significantly impact the market dynamics, challenging DEXTENZA's dominance[1][4].

Financial Trajectory

Revenue Growth

DEXTENZA has consistently shown revenue growth over the past few quarters. In Q2 2023, the net product revenue for DEXTENZA was $15.0 million, representing a 24% growth over the same quarter in 2022. This growth trend has continued into 2024, with the company anticipating full-year revenues to be between $62.0 million and $67.0 million[2][3].

Cash and Funding

Ocular Therapeutix has a strong cash position, with total cash and cash equivalents of $459.7 million as of June 30, 2024. This cash balance is expected to support the company's planned expenses, obligations, and capital expenditure requirements into 2028. Additionally, the company secured an $82.5 million credit facility in 2023, which extends their financial runway into 2025[2][3].

Research and Development Expenses

The company has been investing heavily in research and development, with expenses increasing from $13.1 million in Q2 2022 to $15.1 million in Q2 2023. These expenses are driven by clinical and preclinical programs, including the development of other ophthalmic therapies like OTX-TKI for wet AMD[3].

Regulatory Milestones and Development Activities

DEXTENZA has achieved several regulatory milestones, including FDA approval for the treatment of ocular pain following ophthalmic surgery. The drug has undergone extensive clinical trials, and its developmental activities are well-documented. The report from ResearchAndMarkets.com provides a detailed analysis of these milestones and activities, which are crucial for understanding the current development scenario of DEXTENZA[1][4].

SWOT Analysis and Analyst Views

A comprehensive SWOT analysis highlights the strengths, weaknesses, opportunities, and threats associated with DEXTENZA. The drug's unique mechanism of action and strong clinical trial data are significant strengths. However, the potential competition from emerging therapies and the need for continuous marketing efforts to penetrate a larger market share are notable challenges. Analyst views suggest that DEXTENZA has the potential to dominate the market for postoperative ocular pain, but it must navigate the competitive landscape effectively[1][4].

Key Takeaways

• Revenue Growth: DEXTENZA has shown consistent revenue growth, with projected sales expected to increase until 2032.
• Market Competition: The drug faces competition from emerging therapies, which will impact its market dominance.
• Financial Stability: Ocular Therapeutix has a strong cash position and secured funding to support its operations and development activities.
• Regulatory Milestones: DEXTENZA has achieved significant regulatory milestones, including FDA approval.
• Development Activities: The company continues to invest in research and development to enhance its product portfolio.

FAQs

What is the mechanism of action of DEXTENZA?

DEXTENZA works by releasing dexamethasone directly into the canalicular space of the eye, providing localized anti-inflammatory and analgesic effects.

What are the current revenue projections for DEXTENZA in 2024?

Ocular Therapeutix expects full-year 2024 total net revenues for DEXTENZA to be between $62.0 million and $67.0 million.

How does DEXTENZA compare to other treatments for postoperative ocular pain?

DEXTENZA is unique due to its preservative-free, resorbable intracanalicular insert design, which eliminates the need for topical eye drops. However, it faces competition from emerging therapies that may offer novel approaches to treating postoperative pain.

What is the current cash position of Ocular Therapeutix?

As of June 30, 2024, Ocular Therapeutix has total cash and cash equivalents of $459.7 million.

What are the key regulatory milestones achieved by DEXTENZA?

DEXTENZA has achieved FDA approval for the treatment of ocular pain following ophthalmic surgery and has undergone extensive clinical trials to demonstrate its safety and efficacy.

Sources

1. United States DEXTENZA Drug Insight and Market Forecast - 2032. ResearchAndMarkets.com.
2. Ocular Therapeutix™ Reports Second Quarter 2024 Results. BioSpace.
3. Ocular Therapeutix™ Provides Second Quarter 2023 Financial Results and Corporate Update. BioSpace.
4. United States DEXTENZA Drug Insight and Market Forecast Report. PR Newswire.
5. Ocular Therapeutix™ Provides First Quarter 2023 Financial Results and Corporate Update. GlobeNewswire.