VIGAFYDE Drug Patent Profile

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

Vigafyde is a drug marketed by Pyros Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has three patent family members in two countries.

The generic ingredient in VIGAFYDE is vigabatrin. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vigafyde

A generic version of VIGAFYDE was approved as vigabatrin by ENDO OPERATIONS on April 27^th, 2017.

Summary for VIGAFYDE

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in VIGAFYDE?	VIGAFYDE excipients list
DailyMed Link:	VIGAFYDE at DailyMed

Pharmacology for VIGAFYDE

Drug Class

Anti-epileptic Agent

US Patents and Regulatory Information for VIGAFYDE

VIGAFYDE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pyros Pharms	VIGAFYDE	vigabatrin	SOLUTION;ORAL	217684-001	Jun 17, 2024		RX	Yes	Yes			Y

International Patents for VIGAFYDE

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	202103724
World Intellectual Property Organization (WIPO)	2020039262
United Kingdom	2591389	Pharmaceuticals solution for oral dosage

VIGAFYDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIGAFYDE

Introduction to VIGAFYDE

VIGAFYDE, developed by Pyros Pharmaceuticals, is a groundbreaking oral vigabatrin solution approved by the FDA for the treatment of infantile spasms (IS) in pediatric patients aged 1 month to 2 years. This approval marks a significant milestone, being the first new drug for this condition in 15 years[1][5].

Market Need and Demand

Infantile spasms are a rare and severe form of epilepsy, posing substantial challenges for patients and their families. The lack of recent innovations in this area created a critical need for effective and convenient treatments. VIGAFYDE fills this gap by offering a ready-to-use vigabatrin oral solution, which simplifies the dosing process and enhances the likelihood of accurate dosing[5].

Competitive Landscape

The market for treatments of rare diseases, particularly those affecting small patient populations, is characterized by limited competition. VIGAFYDE's unique formulation and the absence of generic alternatives in this niche market position it as a leader in the treatment of infantile spasms. The restricted distribution program, Vigabatrin REMS, further ensures that VIGAFYDE remains a controlled and monitored treatment option, reducing the likelihood of immediate generic competition[4].

Pricing and Economic Implications

Given the rare nature of the condition and the lack of alternative treatments, VIGAFYDE is likely to command a premium price. The economics of drug development for rare diseases often involve high prices due to the small patient population and the significant investment in research and development. For instance, drugs like Kalydeco for cystic fibrosis can cost several hundred thousand dollars per year, despite targeting a small patient population[3].

Financial Trajectory

Approval and Launch

VIGAFYDE was approved by the FDA on June 17, 2024, and became available to patients in September 2024. This timely launch is expected to generate significant revenue for Pyros Pharmaceuticals, especially considering the drug's unique position in the market[5].

Revenue Projections

Given the high demand for effective treatments in this rare disease segment, VIGAFYDE is anticipated to generate substantial revenue. The drug's premium pricing, combined with its exclusive market position, will likely drive revenue growth in the short to medium term.

Acquisition by Bora Pharmaceuticals

The recent acquisition of Pyros Pharmaceuticals by Bora Pharmaceuticals is expected to further enhance the financial trajectory of VIGAFYDE. Bora's global reach and resources will facilitate broader market penetration and increased investment in marketing and education initiatives, potentially increasing sales and revenue[5].

Patient Support and Access Programs

Pyros Pharmaceuticals has implemented a comprehensive patient support program, Pyros Total Care™, which includes personalized assistance to caregivers, nurse educators, reimbursement support, and clinical pharmacists. This program not only enhances patient outcomes but also improves access to the drug, contributing to its financial success[1].

Regulatory and Safety Considerations

VIGAFYDE is available only through a restricted distribution program, the Vigabatrin REMS, due to the risk of permanent vision loss. This program includes baseline and periodic vision assessments, which, while necessary, may impact the drug's adoption rate and revenue. However, the benefits of the treatment are expected to outweigh these risks for many patients[4].

Market Education and Awareness

The approval of VIGAFYDE has brought renewed enthusiasm to the infantile spasms community, with a focus on enhancing disease education, care pathways, and research investments. Educational initiatives by Pyros and now Bora Pharmaceuticals will be crucial in increasing awareness among healthcare providers and patients, driving market growth[1][5].

Synergies with Other Acquisitions

Bora Pharmaceuticals' acquisition of Upsher-Smith Laboratories and TWi Pharmaceuticals creates synergies that can enhance the market presence of VIGAFYDE. The combined expertise in the pediatric CNS space and rare disease treatments is expected to improve treatment satisfaction and patient outcomes, further boosting the drug's financial performance[5].

Future Outlook

The future outlook for VIGAFYDE is promising, driven by its unique market position, the lack of immediate competition, and the support from Bora Pharmaceuticals. As the drug continues to be marketed and distributed, it is likely to become a standard treatment for infantile spasms, contributing significantly to the financial health of Bora Pharmaceuticals.

Key Takeaways

• Unique Market Position: VIGAFYDE is the first new treatment for infantile spasms in 15 years and the only ready-to-use vigabatrin oral solution.
• High Demand: The drug fills a critical need in a rare disease segment with limited treatment options.
• Premium Pricing: Expected to command a high price due to its niche market and significant R&D investment.
• Comprehensive Support Programs: Pyros Total Care™ enhances patient access and outcomes.
• Regulatory Considerations: Available through a restricted distribution program due to vision loss risks.
• Acquisition Synergies: Bora Pharmaceuticals' acquisition is expected to enhance market penetration and revenue.

FAQs

Q: What is VIGAFYDE used for? A: VIGAFYDE is used as monotherapy for the treatment of infantile spasms in pediatric patients aged 1 month to 2 years.

Q: What makes VIGAFYDE unique? A: VIGAFYDE is the first and only ready-to-use vigabatrin oral solution, simplifying the dosing process and enhancing accurate dosing.

Q: What are the risks associated with VIGAFYDE? A: VIGAFYDE carries a risk of permanent vision loss, necessitating frequent vision assessments and a restricted distribution program.

Q: How is VIGAFYDE distributed? A: VIGAFYDE is available only through the Vigabatrin REMS program due to the risk of vision loss.

Q: What is the impact of the acquisition by Bora Pharmaceuticals on VIGAFYDE? A: The acquisition is expected to enhance market penetration, increase investment in marketing and education, and improve treatment satisfaction and patient outcomes.

Sources

1. Clinical Trial Vanguard: Pyros Pharmaceuticals' FDA-Approved Vigafyde™: The Only Ready-to-Use Vigabatrin Oral Solution.
2. Upsher-Smith: Upsher-Smith Presents Expanded Rare Disease Portfolio at 2024 Child Neurology Society Annual Meeting.
3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
4. FDA: VIGAFYDE (vigabatrin) oral solution.
5. Bora Pharmaceuticals: Bora Pharmaceuticals to Expand Rare Disease Portfolio with Acquisition of US-Based Pyros Pharmaceuticals.