VISTIDE Drug Patent Profile

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

Vistide is a drug marketed by Gilead Sciences Inc and is included in one NDA.

The generic ingredient in VISTIDE is cidofovir. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cidofovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vistide

A generic version of VISTIDE was approved as cidofovir by MYLAN INSTITUTIONAL on June 27^th, 2012.

Summary for VISTIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	11
Patent Applications:	5,022
What excipients (inactive ingredients) are in VISTIDE?	VISTIDE excipients list
DailyMed Link:	VISTIDE at DailyMed

Recent Clinical Trials for VISTIDE

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

Sponsor	Phase
Centro de Investigación en. Enfermedades Infecciosas, Mexico	Phase 2
Gilead Sciences	Phase 1
M.D. Anderson Cancer Center	Phase 1

See all VISTIDE clinical trials

US Patents and Regulatory Information for VISTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VISTIDE	cidofovir	INJECTABLE;INJECTION	020638-001	Jun 26, 1996		DISCN	Yes	No

Expired US Patents for VISTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VISTIDE	cidofovir	INJECTABLE;INJECTION	020638-001	Jun 26, 1996

EU/EMA Drug Approvals for VISTIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences International Limited	Vistide	cidofovir	EMEA/H/C/000121 Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.,	Withdrawn	no	no	no	1997-04-23

International Patents for VISTIDE

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

Country	Patent Number	Title	Estimated Expiration
Canada	1340856	PURINES ETPYRIMIDINES N-PHOSPHONYLMETHOXYALKYLIQUES; LEUR EMPLOI A DES FINS THERAPEUTIQUES (N-PHOSPHONYLMETHOXYALKYL PYRIMIDINES AND PURINES AND THERAPEUTIC APPLICATION THEREOF)
Ireland	60117	N-phosphonylmethoxyalkyl derivatives of pyrimidine and purine bases, methods for their preparation and pharmaceutical compositions therefrom with antiviral activity
European Patent Office	0253412	N-PHOSPHONYLMETHOXYALKYL DERIVATIVES OF PYRIMIDINE AND PURINE BASES, METHODS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREFROM WITH ANTIVIRAL ACTIVITY
Japan	S6345289	N-PHOSPHONYLMETHOXYALKYL DERIVATIVE OF PURINE AND PYRIMIDINE BASE

Supplementary Protection Certificates for VISTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253412	63/1997	Austria		PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: K (97) 1176 19970423
0253412	SPC/GB97/083	United Kingdom		PRODUCT NAME: CIDOFOVIR; REGISTERED: UK EU/1/97/037/001 19970423
0253412	C970036	Netherlands		PRODUCT NAME: CIDOFOVIR,DESGEWENST IN DE VORM VAN EEN ZOUT MET AMMONIA,EEN ALKALIMETAAL OF EEN AMINE; REGISTRATION NO/DATE: EU/1/97/037/001 19970423
0253412	97C0105	Belgium		PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: EU/1/97/037/001 19970423

VISTIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VISTIDE

Introduction

VISTIDE, also known as cidofovir, is an antiviral medication developed by Gilead Sciences for the treatment of Cytomegalovirus (CMV) retinitis, a serious eye infection that can lead to blindness, particularly in individuals with weakened immune systems such as those with HIV/AIDS.

FDA Approval and Market Launch

VISTIDE was the first Gilead medicine to receive FDA approval, which was granted in June 1996. Following this approval, Gilead swiftly launched the product, distributing it to wholesalers and distributors across the country within hours. The rapid launch was a testament to Gilead's commitment to bringing critical medications to market quickly[3].

Initial Market Reception

The launch of VISTIDE was met with positive feedback from the public and medical community. The drug's efficacy in treating CMV retinitis made it a valuable addition to the treatment options available for patients with this condition. This positive reception contributed to its initial success in the market[3].

Sales Performance

In the third quarter of 2000, VISTIDE contributed significantly to Gilead's product sales revenue. Although it was not the top-selling product for Gilead during this period (AmBisome held that position), VISTIDE still generated $1.3 million in sales. This figure, while smaller compared to AmBisome, was part of the overall growth in product sales that Gilead experienced during this quarter[1].

International Market Expansion

Gilead expanded the reach of VISTIDE by signing an agreement with Pharmacia & Upjohn to market the drug outside the United States. This strategic partnership helped in increasing the global availability of VISTIDE, further boosting its sales and market presence[3].

Royalty Revenues

In addition to direct sales, Gilead also earned royalty revenues from the sales of VISTIDE outside the United States. For the third quarter of 2000, Gilead recorded $0.3 million in royalties on VISTIDE sales by Pharmacia Corporation, highlighting the drug's international market impact[1].

Market Segment and Growth Drivers

The cytomegalovirus treatment market, in which VISTIDE operates, is driven by several factors, including increasing awareness and prevalence of CMV infections. The market is expected to grow at a CAGR of 6.6% between 2024 and 2032, with antiviral drugs like cidofovir playing a crucial role in managing CMV infections, especially in immunocompromised patients[4].

Competitive Landscape

The CMV treatment market is competitive, with established pharmaceutical companies vying for market share. Gilead, along with other key players, engages in strategic initiatives such as partnerships and product development to maintain and expand its market position. The intravenous segment, which includes VISTIDE, is expected to hold significant revenue throughout the forecast period[4].

Financial Impact on Gilead Sciences

The success of VISTIDE contributed to Gilead's overall financial growth. In the third quarter of 2000, Gilead's total revenues increased by 17% compared to the same quarter in 1999, partly due to the sales performance of VISTIDE and other products. Although Gilead reported a net loss for the quarter, the revenue growth indicated a positive trend in the company's financial trajectory[1].

Challenges and Future Outlook

Despite its success, the market for CMV treatments faces challenges such as the need for continuous innovation and the rising demand for effective treatments. Gilead and other companies must invest in research and development to stay competitive. The future outlook for VISTIDE and similar drugs remains positive, driven by the growing need for antiviral therapies in both developed and developing economies[4].

Key Takeaways

• FDA Approval and Rapid Launch: VISTIDE was the first Gilead medicine to receive FDA approval and was launched swiftly.
• Positive Market Reception: The drug received positive feedback from the public and medical community.
• International Expansion: VISTIDE was marketed internationally through partnerships.
• Royalty Revenues: Gilead earned royalties from international sales of VISTIDE.
• Market Growth Drivers: Increasing awareness and prevalence of CMV infections drive market growth.
• Competitive Landscape: The CMV treatment market is competitive, with Gilead and other companies engaging in strategic initiatives.
• Financial Impact: VISTIDE contributed to Gilead's revenue growth in the early 2000s.

FAQs

1. What is VISTIDE used for? VISTIDE, or cidofovir, is used to treat Cytomegalovirus (CMV) retinitis, a serious eye infection that can lead to blindness, particularly in individuals with weakened immune systems.

2. When was VISTIDE approved by the FDA? VISTIDE was approved by the FDA in June 1996.

3. How did Gilead expand the market for VISTIDE? Gilead expanded the market for VISTIDE by signing an agreement with Pharmacia & Upjohn to market the drug outside the United States.

4. What was the financial impact of VISTIDE on Gilead Sciences? VISTIDE contributed to Gilead's overall revenue growth, with the company reporting a 17% increase in total revenues in the third quarter of 2000 compared to the same quarter in 1999.

5. What are the growth drivers for the CMV treatment market? The growth drivers for the CMV treatment market include increasing awareness and prevalence of CMV infections, as well as the development of new and effective treatments.

Sources

1. Gilead Sciences Announces Third Quarter 2000 Financial Results - Gilead Sciences
2. Takeda Quarterly Financial Report - Takeda Pharmaceuticals
3. How Gilead Went From Unprofitable To Biopharmaceutical Giant - Cascade
4. Cytomegalovirus Treatment Market Size – Trends Report, 2032 - Global Market Insights
5. Chimerix Announces First Quarter 2017 Financial Results - Chimerix