VIADUR Drug Patent Profile

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

Viadur is a drug marketed by Ortho Mcneil Janssen and is included in one NDA.

The generic ingredient in VIADUR is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viadur

A generic version of VIADUR was approved as leuprolide acetate by SANDOZ on August 4^th, 1998.

Summary for VIADUR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIADUR
DailyMed Link:	VIADUR at DailyMed

Recent Clinical Trials for VIADUR

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

Sponsor	Phase
NRG Oncology	Phase 2
ECOG-ACRIN Cancer Research Group	Phase 3
Jonsson Comprehensive Cancer Center	Phase 2

See all VIADUR clinical trials

US Patents and Regulatory Information for VIADUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000		DISCN	No	No

Expired US Patents for VIADUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000

International Patents for VIADUR

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

Country	Patent Number	Title	Estimated Expiration
Germany	69807748
Czech Republic	300378	Stabilní nevodná formulace peptidové slouceniny a zpusob její prípravy (Stable non-aqueous formulation of a peptide compound and method for preparation thereof)
Portugal	1041974
Spain	2215967

VIADUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Viadur

Introduction

Viadur, a titanium implant drug-delivery system developed by Alza Corporation and later licensed to Bayer, was approved by the US FDA in March 2000 for managing symptoms associated with advanced prostate cancer. Despite its innovative technology, Viadur's market presence was short-lived due to several key factors.

Approval and Initial Market Entry

Viadur was the first titanium implant drug-delivery system, utilizing Duros technology to deliver leuprolide acetate, a gonadotropin-releasing hormone (Gn-RH) agonist. This system was designed to reduce testosterone production continuously over a 12-month period, alleviating symptoms such as pain and urinary problems in prostate cancer patients[3][5].

Market Reception and Sales Performance

Despite its innovative delivery mechanism, Viadur failed to gain significant traction in the market. The drug's sales stalled, and the market demand did not improve over time. This lackluster performance was a critical factor in Bayer's decision to discontinue the drug's marketing[1][4].

Factors Leading to Discontinuation

Several key factors contributed to the discontinuation of Viadur:

Diminished Market Demand

The primary reason for discontinuing Viadur was the diminished market demand. The drug did not achieve the expected sales figures, and the market did not show signs of improvement[1][4].

Growing Manufacturing Costs

Increasing manufacturing costs also played a significant role in the decision. As the demand for Viadur was low, the cost per unit became prohibitively high, making it unsustainable for Bayer to continue production[1][4].

Availability of Alternative Therapies

The presence of alternative therapies for managing advanced prostate cancer symptoms further reduced the need for Viadur. Patients and healthcare providers had other options, which diminished the market viability of Viadur[1][4].

Impact on Competitors

The discontinuation of Viadur had a positive impact on competitors, particularly Indevus Pharmaceuticals. Indevus's product, Vantas (histrelin), became the only 12-month implant available for the palliative treatment of advanced prostate cancer once Viadur supplies were depleted. Indevus committed to providing continuity of care for current Viadur patients by ensuring ready access to Vantas[1].

Financial Implications

The financial trajectory of Viadur was marked by declining revenues and increasing costs. The decision to discontinue the drug was likely driven by the financial unsustainability of continuing to produce and market a product with limited demand. Bayer fulfilled existing orders until the current supplies were depleted, expected by the end of April 2008, but did not invest further in the product[1][4].

Safety and Efficacy Considerations

It is important to note that the decision to discontinue Viadur was not due to any safety or efficacy issues. The drug had been approved and was effective in managing symptoms of advanced prostate cancer, but its market viability was the main concern[1][4].

Patient Transition

Bayer advised patients to discuss alternative therapies with their healthcare providers. This transition was facilitated by the availability of other treatments, ensuring that patients did not experience a gap in care[1][4].

Conclusion

The story of Viadur highlights the challenges faced by innovative pharmaceutical products in the market. Despite its groundbreaking technology, Viadur's failure to achieve significant market demand and the associated high manufacturing costs led to its discontinuation. This case serves as a reminder of the complex interplay between innovation, market demand, and financial sustainability in the pharmaceutical industry.

Key Takeaways

• Innovative Technology: Viadur was the first titanium implant drug-delivery system using Duros technology.
• Market Demand: Diminished market demand was the primary reason for discontinuation.
• Manufacturing Costs: Growing manufacturing costs made the product financially unsustainable.
• Alternative Therapies: Availability of alternative treatments reduced the need for Viadur.
• Competitor Impact: Indevus Pharmaceuticals benefited from the discontinuation of Viadur.
• Financial Implications: Declining revenues and increasing costs led to the financial unsustainability of Viadur.
• Safety and Efficacy: The decision was not due to safety or efficacy issues.

FAQs

Q: Why was Viadur discontinued by Bayer? A: Viadur was discontinued due to diminished market demand and growing manufacturing costs, not due to any safety or efficacy issues[1][4].

Q: What was the innovative aspect of Viadur? A: Viadur was the first titanium implant drug-delivery system using Duros technology to manage symptoms of advanced prostate cancer[3][5].

Q: How did the discontinuation of Viadur affect competitors? A: The discontinuation of Viadur benefited competitors like Indevus Pharmaceuticals, whose product Vantas became the only 12-month implant available for the palliative treatment of advanced prostate cancer[1].

Q: What were the common side effects of Viadur? A: Common side effects included hot flashes, asthenia, gynecomastia, depression, and sweating. Local side effects included bruising and burning[4].

Q: Did the discontinuation of Viadur affect patient care? A: No, the discontinuation did not affect patient care as alternative therapies were available, and patients were advised to discuss these options with their healthcare providers[1][4].

Sources

1. PharmaTimes - Bayer discontinues Viadur due to 'diminished market demand'
2. MDPI - Local Drug Delivery in Bladder Cancer: Advances of Nano/Micro ...
3. FDA - 21-088 Viadur Clinical Pharmacology Biopharmaceutics Review
4. FierceBiotech - Marketing of Viadur(R) (leuprolide acetate implant) to Phase Out by April 2008
5. FDA - Drug Approval Package: Viadur (Leuprolide Acetate Implant) NDA ...