RETISERT Drug Patent Profile

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

Retisert is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in RETISERT is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Retisert

A generic version of RETISERT was approved as fluocinolone acetonide by TARO on April 27^th, 1982.

Summary for RETISERT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	9
Patent Applications:	4,327
Drug Prices:	Drug price information for RETISERT
What excipients (inactive ingredients) are in RETISERT?	RETISERT excipients list
DailyMed Link:	RETISERT at DailyMed

See drug prices for RETISERT

Recent Clinical Trials for RETISERT

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

Sponsor	Phase
Unity Health Toronto	Phase 2
St. Michael's Hospital, Toronto	Phase 2
Pradeepa Yoganathan	Phase 2

See all RETISERT clinical trials

Pharmacology for RETISERT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005		RX	Yes	Yes

Expired US Patents for RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	6,217,895
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	6,548,078

International Patents for RETISERT

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0010869
Canada	2367092	METHODE DE TRAITEMENT ET/OU DE PREVENTION DE MALADIES DE LA RETINE A L'AIDE DE CORTICOSTEROIDES A LIBERATION CONTROLEE (METHOD FOR TREATING AND/OR PREVENTING RETINAL DISEASES WITH SUSTAINED RELEASE CORTICOSTEROIDS)
Australia	2005200243
European Patent Office	1162978
South Korea	20010112357

Supplementary Protection Certificates for RETISERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	132014902285293	Italy		PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504

RETISERT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RETISERT

Introduction to RETISERT

RETISERT, developed by Bausch & Lomb in collaboration with Control Delivery Systems, is a sustained-release intravitreal implant designed to deliver corticosteroid therapy, specifically fluocinolone acetonide, to the posterior segment of the eye. This implant is primarily used to treat chronic noninfectious posterior uveitis, a condition that can lead to significant vision loss if not managed effectively[4][5].

Market Size and Growth

The ocular drug delivery technology market, which includes products like RETISERT, is experiencing significant growth. As of 2022, the global ocular drug delivery technology market was valued at USD 17.64 billion and is projected to reach USD 38.74 billion by 2030, growing at a CAGR of 10.33% between 2023 and 2030. This growth is driven by advancements in drug delivery technologies, increasing prevalence of ocular disorders, and the rising geriatric population[1].

Key Market Drivers

• Technological Advancements: Innovations in drug delivery systems, such as the Durasert® platform by EyePoint Pharmaceuticals, are enhancing the efficacy and convenience of ocular treatments. RETISERT's sustained-release mechanism, which delivers medication over approximately 2.5 years, is a significant technological advancement in this field[1][4].
• Increasing Prevalence of Ocular Disorders: Conditions like chronic noninfectious posterior uveitis, which RETISERT treats, are becoming more prevalent. This increase in patient population drives the demand for effective treatments[4].
• Strong Healthcare Infrastructure: Regions like North America, which account for a significant portion of the global market, have robust healthcare infrastructure and regulatory frameworks that support the adoption of advanced ocular drug delivery technologies[1].

Financial Performance and Revenue

While specific financial data for RETISERT alone is not readily available, the performance of companies involved in ocular drug delivery technologies provides insight into the broader market trends.

• Revenue Growth: Companies like EyePoint Pharmaceuticals, which develop and market similar sustained-release ocular implants, have seen significant revenue growth. For example, EyePoint Pharmaceuticals reported strong customer order growth for their products DEXYCU® and YUTIQ®, which are part of the same market segment as RETISERT[2].
• Cost and Reimbursement: RETISERT's high price point, approximately $18,000 per implant, can be a barrier to adoption. However, ophthalmologists and the manufacturer have successfully made the case for reimbursement to insurance companies by highlighting the long-term cost savings and efficacy of the treatment compared to alternative therapies[4].

Operational Expenses and Profitability

The operational expenses for companies in this sector are substantial, particularly in areas such as research and development, sales and marketing, and general administrative costs.

• Research and Development: Significant investments are made in R&D to develop and improve ocular drug delivery technologies. For instance, EyePoint Pharmaceuticals incurred substantial research and development expenses, which were partially offset by decreases in other areas[2].
• Sales and Marketing: The commercial launch and marketing of products like RETISERT require considerable investment. EyePoint Pharmaceuticals saw an increase in sales and marketing expenses as they expanded their customer base and product penetration[2].

Challenges and Risks

Despite the positive market dynamics, there are challenges and risks associated with RETISERT and similar products:

• Reimbursement Issues: High costs can lead to resistance from insurance companies, affecting reimbursement and patient access. However, education and evidence of long-term benefits can mitigate these issues[4].
• Adverse Events: Clinical trials have shown that RETISERT can lead to ocular adverse events such as cataracts, increased intraocular pressure, and procedural complications. These risks need to be carefully managed and communicated to patients and healthcare providers[5].

Future Outlook

The future of RETISERT and similar ocular drug delivery technologies looks promising due to several factors:

• Increasing Demand: The growing prevalence of ocular disorders and the aging population will continue to drive demand for effective and convenient treatments.
• Technological Innovations: Ongoing research and development are expected to improve the efficacy, safety, and convenience of ocular drug delivery systems.
• Regulatory Support: Strong regulatory frameworks in regions like North America will continue to support the development and approval of new ocular drug delivery technologies[1].

Key Takeaways

• RETISERT is part of a rapidly growing ocular drug delivery technology market.
• The product's sustained-release mechanism and local delivery of corticosteroids make it an effective treatment for chronic noninfectious posterior uveitis.
• Despite high costs, the long-term benefits and cost savings of RETISERT can justify reimbursement.
• Ongoing technological innovations and strong healthcare infrastructure will continue to drive market growth.

FAQs

Q: What is RETISERT used for? A: RETISERT is used to treat chronic noninfectious posterior uveitis, a condition that can cause significant vision loss.

Q: How long does RETISERT deliver medication? A: RETISERT delivers fluocinolone acetonide for approximately 2.5 years.

Q: What are the common adverse events associated with RETISERT? A: Common adverse events include cataracts, increased intraocular pressure, and procedural complications.

Q: Why is RETISERT expensive? A: The high cost of RETISERT is due to its advanced technology and the long-term delivery mechanism, although it can offer long-term cost savings compared to alternative treatments.

Q: Is RETISERT covered by insurance? A: Yes, although there may be initial resistance due to the high cost, education and evidence of long-term benefits can help secure reimbursement.

Cited Sources

1. Zion Market Research: Ocular Drug Delivery Technology Market Size, Shares, Forecast 2030
2. EyePoint Pharmaceuticals: EyePoint Pharmaceuticals Reports Third Quarter 2019 Financial Results and Highlights Recent Corporate Progress
3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market
4. Ophthalmology Management: Sustained-Release Drugs: Heralds of the Future
5. Bausch & Lomb: RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg Product Brochure