VITRASERT Drug Patent Profile

Which patents cover Vitrasert, and what generic alternatives are available?

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

The generic ingredient in VITRASERT is ganciclovir. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.

Summary for VITRASERT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	1
DailyMed Link:	VITRASERT at DailyMed

Recent Clinical Trials for VITRASERT

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

Sponsor	Phase
Johns Hopkins Bloomberg School of Public Health	Phase 2/Phase 3

See all VITRASERT clinical trials

US Patents and Regulatory Information for VITRASERT

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	VITRASERT	ganciclovir	IMPLANT;IMPLANTATION	020569-001	Mar 4, 1996		DISCN	No	No

Expired US Patents for VITRASERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	VITRASERT	ganciclovir	IMPLANT;IMPLANTATION	020569-001	Mar 4, 1996

EU/EMA Drug Approvals for VITRASERT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..	Vitrasert Implant	ganciclovir	EMEA/H/C/000120 The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).	Withdrawn	no	no	no	1997-03-18

International Patents for VITRASERT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0861659	Systèmes d'administration de médicaments à libération prolongée (Sustained release drug delivery devices)
Australia	660012
World Intellectual Property Organization (WIPO)	9214450
Japan	2003002825	DELIVERY APPARATUS FOR SUSTAINED-RELEASE DRUG
Canada	2104699	DISPOSITIFS DE DELIVRANCE DE MEDICAMENTS A LIBERATION PROLONGEE (SUSTAINED RELEASE DRUG DELIVERY DEVICES)
Austria	171617

Supplementary Protection Certificates for VITRASERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	2002/028	Ireland		PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
0694547	SPC/GB02/027	United Kingdom		PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
0694547	03C0003	France		PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
0694547	C300071	Netherlands		PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920

VITRASERT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vitrasert

Introduction to Vitrasert

Vitrasert, a ganciclovir 0.45mg intravitreal implant, was approved by the FDA in 1996 for the treatment of AIDS-associated CMV (Cytomegalovirus) retinitis. This implantable drug delivery device has been a significant advancement in the management of this debilitating condition.

Clinical Efficacy

Vitrasert has demonstrated superior efficacy in clinical trials. In a Phase III clinical trial involving 188 AIDS patients with newly diagnosed CMV retinitis, patients who received Vitrasert had a median time to disease progression of 216 days, compared to 106 days for those receiving intravenous ganciclovir[4].

Market Impact

Adoption and Usage

The approval and subsequent use of Vitrasert marked a shift towards more targeted and sustained drug delivery methods. This device reduces the need for systemic or local adjunctive therapy and has been shown to stabilize or improve visual acuity in 80% of patients. The localized delivery of the therapeutic agent minimizes systemic side effects, making it a preferred option for managing CMV retinitis[4].

Market Size and Growth

While specific financial data for Vitrasert alone is not readily available, the broader market for implantable drug delivery devices provides context. The global implantable drug delivery devices market was valued at USD 8,731.80 million in 2022 and is projected to reach USD 17,896.16 million by 2031, growing at a CAGR of 8.30% during the forecast period (2023-2031)[1].

Financial Trajectory

Revenue Contribution

Vitrasert, as part of the ophthalmic segment of implantable drug delivery devices, contributes to the revenue growth in this market. Companies like Bausch and Lomb, the manufacturer of Vitrasert, benefit from the increasing demand for minimally invasive and targeted drug delivery systems.

Funding and Investments

The financial trajectory of companies involved in the development and commercialization of such devices is often supported by significant investments. For example, EyePoint Pharmaceuticals, another player in the ophthalmic drug delivery market, secured a $60 million debt facility to support the launch of their products, including those similar in nature to Vitrasert[5].

Challenges and Opportunities

Regulatory Environment

The market for implantable drug delivery devices, including Vitrasert, is subject to stringent government regulations. Compliance with these regulations can be a significant challenge but also ensures the safety and efficacy of the devices[1].

Technological Advancements

Continuous technological advancements in the field of implantable drug delivery devices present opportunities for growth. Newer devices and treatments, such as those for uveitis and diabetic macular edema, are being developed and commercialized, expanding the market potential[4].

Regional Dynamics

North America

North America, particularly the United States, is a significant market for implantable drug delivery devices. The high prevalence of chronic diseases, including AIDS and associated conditions like CMV retinitis, drives the demand for devices like Vitrasert. This region is expected to exhibit a CAGR of 7.90% during the forecast period[1].

Europe

Europe is also a key market, with countries like the UK, Germany, and Spain showing significant growth. The acceptance of advanced medical technologies, such as drug-eluting stents and brachytherapy, contributes to the market's expansion in this region[1].

Key Takeaways

• Clinical Efficacy: Vitrasert has shown superior efficacy in treating CMV retinitis, with longer disease progression times compared to traditional treatments.
• Market Impact: The device has contributed to the shift towards targeted and sustained drug delivery, reducing systemic side effects.
• Financial Trajectory: While specific financial data for Vitrasert is not available, the broader market for implantable drug delivery devices is growing significantly.
• Challenges and Opportunities: The market faces regulatory challenges but is driven by technological advancements and increasing demand for minimally invasive treatments.
• Regional Dynamics: North America and Europe are key markets, driven by the prevalence of chronic diseases and the adoption of advanced medical technologies.

FAQs

1. What is Vitrasert used for? Vitrasert is used for the treatment of AIDS-associated CMV (Cytomegalovirus) retinitis.

2. How does Vitrasert compare to traditional treatments? Vitrasert has been shown to have a longer median time to disease progression (216 days) compared to intravenous ganciclovir (106 days)[4].

3. What are the benefits of using Vitrasert? Vitrasert provides localized delivery of the therapeutic agent, reducing systemic side effects and the need for adjunctive therapy. It also stabilizes or improves visual acuity in a significant percentage of patients[4].

4. What is the current market size for implantable drug delivery devices? The global implantable drug delivery devices market was valued at USD 8,731.80 million in 2022 and is projected to reach USD 17,896.16 million by 2031[1].

5. Which regions are the most significant markets for implantable drug delivery devices? North America and Europe are the most significant markets, with North America being the largest revenue contributor and Europe expected to exhibit the highest CAGR during the forecast period[1].

Sources

1. Straits Research: Implantable Drug Delivery Devices Market Size, Growth and ...
2. EyePoint Pharmaceuticals: EyePoint Pharmaceuticals Secures Up to $60 Million Debt Facility
3. Ophthalmology Web: Implantable Posterior Segment Drug Delivery Devices
4. GlobeNewswire: EyePoint Pharmaceuticals Secures Up to $60 Million Debt Facility