TRIESENCE Drug Patent Profile

When do Triesence patents expire, and when can generic versions of Triesence launch?

Triesence is a drug marketed by Harrow Eye and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-five patent family members in twenty-one countries.

The generic ingredient in TRIESENCE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Triesence

A generic version of TRIESENCE was approved as triamcinolone acetonide by TARO on October 1^st, 1986.

Summary for TRIESENCE

International Patents:	25
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	10
Patent Applications:	4,317
Drug Prices:	Drug price information for TRIESENCE
What excipients (inactive ingredients) are in TRIESENCE?	TRIESENCE excipients list
DailyMed Link:	TRIESENCE at DailyMed

See drug prices for TRIESENCE

Recent Clinical Trials for TRIESENCE

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

Sponsor	Phase
Oxular Limited	Phase 2
Wake Forest University Health Sciences	Phase 4
Bausch & Lomb Incorporated	N/A

See all TRIESENCE clinical trials

Pharmacology for TRIESENCE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for TRIESENCE

TRIESENCE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007		RX	Yes	Yes	8,211,880
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007		RX	Yes	Yes	8,128,960		Y

Expired US Patents for TRIESENCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007	6,395,294

International Patents for TRIESENCE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101555293
Russian Federation	2010141542	НИЗКОВЯЗКИЕ ВЫСОКОФЛОКУЛИРОВАННЫЕ СУСПЕНЗИИ ТРИАМЦИНОЛОНА АЦЕТОНИДА ДЛЯ ИНТРАВИТРЕАЛЬНЫХ ИНЪЕКЦИЙ
Japan	5581227
Spain	2471122

Market Dynamics and Financial Trajectory for TRIESENCE

Introduction

TRIESENCE, a preservative-free synthetic corticosteroid developed by Novartis and now under the umbrella of Harrow Health, has been a crucial product in the ophthalmic pharmaceutical market. After a significant period of shortage, Harrow is relaunching TRIESENCE, marking a pivotal moment for both the company and the healthcare industry.

Historical Context and Acquisition

In January 2023, Harrow acquired the exclusive U.S. rights to five FDA-approved branded ophthalmic products from Novartis, including TRIESENCE, for $130 million plus an additional $45 million contingent on the commercial launch of TRIESENCE[3][4].

Product Indications and Importance

TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for visualization during vitrectomy and the treatment of ocular inflammatory conditions unresponsive to topical corticosteroids. It is also used for conditions such as sympathetic ophthalmia, temporal arteritis, and uveitis. The product's preservative-free formulation reduces the risk of adverse reactions, making it a trusted and effective treatment option in ophthalmology[1][3][4].

Manufacturing and Supply Chain Challenges

TRIESENCE has been on the FDA Drug Shortage List for over five years due to manufacturing delays and supply chain issues. This shortage resulted in no inventory available in the U.S. market for over two years, creating a significant demand vacuum[1][3].

Relaunch and Manufacturing Updates

Harrow has successfully manufactured the first of three commercial-scale process performance qualification (PPQ) batches of TRIESENCE. The remaining two PPQ batches are scheduled, and if all batches meet specifications, TRIESENCE is set to relaunch in 2024. Harrow is committed to quickly building commercial inventories, although initial supplies may not fully meet market demand[1].

Market Readiness and Pre-Commercial Activities

Harrow has initiated pre-commercial activities, including discussions with strategic accounts for pre-orders. This proactive approach aims to ensure market readiness and smooth distribution once the product is relaunched[1][4].

Financial Impact and Revenue Potential

The relaunch of TRIESENCE is expected to have a significant financial impact on Harrow. The company has seen a 33% increase in revenues in the first quarter of 2024 compared to the prior year, partly due to the anticipation of TRIESENCE's return. Harrow expects to meet its 2024 revenue guidance of more than $180 million, with TRIESENCE contributing substantially to this growth[2].

Revenue Growth and Projections

Harrow's financial results for the first quarter of 2024 show net revenues of $34.6 million, a notable increase from the $26.1 million in the prior-year quarter. The company's gross margin and core gross margin remain strong, indicating a robust financial foundation for the relaunch of TRIESENCE[2].

Operational Expenses and Long-Term Potential

While the short-term operational expenses are expected to increase due to the manufacturing and pre-commercial activities, the long-term revenue potential of TRIESENCE is substantial. Investors are advised to monitor the completion of the remaining PPQ batches and initial sales figures to gauge the success of the relaunch[1][2].

Market Acceptance and Demand

The pent-up demand for TRIESENCE, given its absence for over two years, presents a unique opportunity for Harrow to regain market share quickly. Ophthalmologists and retina specialists have been eagerly awaiting the product's return, which is expected to improve patient outcomes significantly[1][3].

Competitive Landscape

Harrow's acquisition of TRIESENCE and other ophthalmic products from Novartis has positioned the company as a leader in the U.S. ophthalmic pharmaceutical market. The successful relaunch of TRIESENCE will further solidify Harrow's market position and complement its existing portfolio of ophthalmic prescription products[3][4].

Regulatory and Compliance Aspects

The transfer of the New Drug Application (NDA) for TRIESENCE from Novartis to Harrow was completed ahead of schedule, which was a critical step in advancing the product's relaunch strategy. This transfer ensured that Harrow could implement its market access, marketing, and inventory management strategies effectively[4].

Key Takeaways

• Successful Manufacturing: Harrow has successfully manufactured the first PPQ batch of TRIESENCE, with the remaining batches scheduled.
• Market Readiness: Pre-commercial activities are underway to ensure smooth distribution and market readiness.
• Financial Impact: The relaunch is expected to significantly contribute to Harrow's revenue growth, with projected revenues exceeding $180 million in 2024.
• Market Demand: Pent-up demand due to the product's absence for over two years presents a unique opportunity for Harrow to regain market share.
• Regulatory Compliance: The NDA transfer from Novartis to Harrow has been completed, paving the way for the product's relaunch.

FAQs

Q: What is TRIESENCE, and what are its indications?

TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL is a preservative-free synthetic corticosteroid used for visualization during vitrectomy and the treatment of ocular inflammatory conditions unresponsive to topical corticosteroids. It is also indicated for conditions such as sympathetic ophthalmia, temporal arteritis, and uveitis[1][3][4].

Q: Why was TRIESENCE in shortage?

TRIESENCE was on the FDA Drug Shortage List for over five years due to manufacturing delays and supply chain issues, resulting in no inventory available in the U.S. market for over two years[1][3].

Q: Who acquired the rights to TRIESENCE, and when?

Harrow Health acquired the exclusive U.S. rights to TRIESENCE from Novartis in January 2023 as part of a $130 million deal[3][4].

Q: What are the financial expectations for Harrow with the relaunch of TRIESENCE?

Harrow expects to meet its 2024 revenue guidance of more than $180 million, with the relaunch of TRIESENCE contributing significantly to this growth. The company has already seen a 33% increase in revenues in the first quarter of 2024 compared to the prior year[2].

Q: How is Harrow preparing for the market relaunch of TRIESENCE?

Harrow has initiated pre-commercial activities, including discussions with strategic accounts for pre-orders, to ensure market readiness and smooth distribution once the product is relaunched[1][4].

Sources

1. Harrow Provides TRIESENCE® Relaunch Update - Stock Titan
2. Harrow Announces First Quarter 2024 Financial Results - Business Wire
3. Harrow relaunches Triesence to the US market - Glance
4. Harrow completes transfer of Triesence NDA - Modern Retina
5. Harrow Health stock set for gains as TRIESENCE and MELT-300 drive growth - Investing.com

Last updated: 2024-12-16