FILSUVEZ Drug Patent Profile

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

Filsuvez is a drug marketed by Chiesi and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-six patent family members in thirty-three countries.

The generic ingredient in FILSUVEZ is birch triterpenes. Two suppliers are listed for this compound. Additional details are available on the birch triterpenes profile page.

DrugPatentWatch^® Generic Entry Outlook for Filsuvez

Filsuvez will be eligible for patent challenges on December 18, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 18, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FILSUVEZ

International Patents:	86
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
What excipients (inactive ingredients) are in FILSUVEZ?	FILSUVEZ excipients list
DailyMed Link:	FILSUVEZ at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FILSUVEZ

Constraining patent/regulatory exclusivity:

TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER

NDA:

215064

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for FILSUVEZ

FILSUVEZ is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes	11,266,660
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes	11,083,733		Y
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes	9,827,214

International Patents for FILSUVEZ

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

Country	Patent Number	Title	Estimated Expiration
Australia	2010323158	Use of an oleo gel containing triterpene for healing wounds
Australia	2005253732	Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel
Cyprus	2016025
Russian Federation	2020125679	БЕТУЛИН-СОДЕРЖАЩИЕ ЭКСТРАКТЫ ИЗ БЕРЕЗОВОЙ КОРЫ И СОСТАВ НА ИХ ОСНОВЕ

Supplementary Protection Certificates for FILSUVEZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758555	32/2016	Austria		PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 (MITTEILUNG) 20160118
1758555	353 5017-2016	Slovakia		PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069/001 20160118
1758555	CR 2016 00032	Denmark		PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118
1758555	PA2016023,C1758555	Lithuania		PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114

Market Dynamics and Financial Trajectory for Filsuvez

Introduction to Filsuvez

Filsuvez, a topical gel containing birch triterpenes, has marked a significant milestone in the treatment of Epidermolysis Bullosa (EB), a rare and severe genetic skin disorder. Developed by Amryt Pharma and now owned by Chiesi Global Rare Diseases, Filsuvez has garnered substantial attention for its efficacy in treating wounds associated with junctional and dystrophic EB.

Regulatory Approval and Milestones

The FDA approved Filsuvez in December 2023 for the treatment of partial thickness wounds in patients with junctional or dystrophic EB, aged six months and older. This approval follows a complex regulatory journey, including an initial rejection by the FDA in February 2022, which prompted Amryt to file a formal dispute resolution request. The EU had already granted marketing authorization for Filsuvez in June 2022[1][2].

Clinical Efficacy and Trials

The approval of Filsuvez is backed by data from the Phase III EASE study, a double-blinded, randomized, and vehicle-controlled trial. This study demonstrated accelerated wound healing, a reduction in overall wound burden, and lower pain associated with changing wound dressings in patients treated with Filsuvez. The trial marked the first successful Phase III top-line readout for an EB treatment, highlighting Filsuvez's potential in addressing the cutaneous manifestations of EB[1][4].

Market Potential

Amryt Pharma estimated that if approved, the global market for Filsuvez could exceed $1 billion. This projection is based on the drug's unique position as the first approved therapeutic treatment for EB patients, a market that has been devoid of approved treatments until now[4].

Acquisition and Financial Implications

Chiesi Global Rare Diseases acquired Amryt Pharma in January 2023 for $1.25 billion upfront, with a contingent payment of up to $225 million if Filsuvez met certain milestones, including FDA approval. This acquisition not only secured Filsuvez but also added other rare disease assets like Myalept (metreleptin) and Mycapssa (octreotide) to Chiesi's portfolio[1].

Financial Performance and Projections

Amryt Pharma's financial reports before the acquisition indicated strong growth in its other products. For instance, metreleptin revenues grew by 10.3% year-over-year in Q3 2022, and Mycapssa revenues saw a 292.8% increase year-over-year during the same period. The company reaffirmed its full-year 2022 revenue guidance of $260-$270 million, representing a 17-21% year-over-year growth[3].

Revenue Streams and Market Impact

With Filsuvez's approval, Chiesi is poised to leverage its existing global infrastructure to commercialize the drug. The European launch of Filsuvez was already progressing well before the FDA approval, with the drug being prescribed and reimbursed in countries like Germany and Austria. The global market for Filsuvez is expected to be substantial, given its unique status as the first approved treatment for EB-related wounds[1][4].

Competitive Landscape

Filsuvez joins a small but growing market of treatments for EB. Krystal Biotech’s Vyjuvek, approved in May 2023 for dystrophic EB, is another significant player in this space. Vyjuvek is the first-ever topical and redosable gene therapy, marking a new era in EB treatment. The approval of Filsuvez further expands the treatment options available to patients with EB[1].

Patient and Market Impact

The approval of Filsuvez is a significant milestone for patients and families living with EB. According to Brett Kopelan, executive director of debra of America, Filsuvez provides a safe and effective treatment option for the most prominent and difficult symptom of EB—open wounds that may not heal. This treatment integrates into existing care routines, allowing patients to administer it at home, which is a crucial aspect for managing a chronic condition like EB[1][2].

Future Outlook and Research

The success of Filsuvez has boosted EB research, with organizations like the EB Research Partnership continuing to innovate and accelerate the path to a cure. The approval of Filsuvez has shown that getting a drug for EB approved and on the market is possible, encouraging further research and development in this area[2][5].

Key Takeaways

• Filsuvez is the first approved treatment for wounds associated with junctional and dystrophic EB.
• The drug was developed by Amryt Pharma and acquired by Chiesi Global Rare Diseases.
• Clinical trials, including the Phase III EASE study, have demonstrated its efficacy in wound healing and pain reduction.
• The global market potential for Filsuvez is estimated to exceed $1 billion.
• The drug's approval marks a significant milestone for EB patients and families.
• Chiesi plans to leverage its global infrastructure to commercialize Filsuvez.

FAQs

What is Filsuvez used for?

Filsuvez is a topical gel used for the treatment of partial thickness wounds in patients with junctional or dystrophic Epidermolysis Bullosa (EB), aged six months and older.

Who developed Filsuvez?

Filsuvez was originally developed by Amryt Pharma, which was acquired by Chiesi Global Rare Diseases in January 2023.

What is the clinical evidence supporting Filsuvez?

The approval of Filsuvez is backed by data from the Phase III EASE study, which demonstrated accelerated wound healing, reduced overall wound burden, and lower pain associated with changing wound dressings.

How much did Chiesi pay to acquire Amryt Pharma?

Chiesi Global Rare Diseases acquired Amryt Pharma for $1.25 billion upfront, with a contingent payment of up to $225 million if Filsuvez met certain milestones, including FDA approval.

What is the market potential for Filsuvez?

The global market for Filsuvez is estimated to exceed $1 billion, making it a significant addition to the rare disease treatment market.

How does Filsuvez compare to other EB treatments?

Filsuvez is the first approved treatment for wounds associated with junctional EB and joins other treatments like Krystal Biotech’s Vyjuvek, which is approved for dystrophic EB.

Cited Sources:

1. Biospace: Chiesi's $1.25B Amryt Buy Pays Off with FDA Approval of Filsuvez
2. EB Research: FDA Approves FILSUVEZ® (birch triterpenes) topical gel for the treatment of partial thickness wounds
3. Biospace: Amryt Reports Q3 2022 Financial and Operational Results
4. Biospace: Amryt Eyes Approval for Epidermolysis Bullosa Drug Filsuvez
5. EB Research Network: EB Research Network Report 2022