Birch triterpenes - Generic Drug Details

What are the generic sources for birch triterpenes and what is the scope of patent protection?

Birch triterpenes is the generic ingredient in one branded drug marketed by Chiesi and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Birch triterpenes has eighty-six patent family members in thirty-three countries.

Two suppliers are listed for this compound.

Summary for birch triterpenes

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

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

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

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.

Recent Clinical Trials for birch triterpenes

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

Sponsor	Phase
Minia University	Phase 1
Oregon Health and Science University	Phase 2
National Center for Complementary and Integrative Health (NCCIH)	Phase 2

See all birch triterpenes clinical trials

US Patents and Regulatory Information for birch triterpenes

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
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	9,352,041
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	8,828,444		Y
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 birch triterpenes

Country	Patent Number	Title	Estimated Expiration
Canada	2571606	AGENT OLEOGELIFIANT CONTENANT DU TRITERPENE, OLEOGEL CONTENANT DU TRITERPENE ET PROCEDE DE FABRICATION D'UN AGENT OLEOGELIFIANT CONTENANT DU TRITERPENE (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, TRITERPENE-CONTAINING OLEOGEL AND METHOD FOR PRODUCING A TRITERPENE-CONTAINING OLEOGEL)
South Africa	201203784	USE OF AN OLEO GEL CONTAINING TRITERPENE FOR HEALING WOUNDS
Singapore	11202003668Y	BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION
China	1972668	Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel
Japan	2016185996	表皮水泡症の創傷治癒剤 (AGENT FOR HEALING WOUNDS OF EPIDERMOLYSIS BULLOSA)
World Intellectual Property Organization (WIPO)	2011064271
Japan	4468987

Supplementary Protection Certificates for birch triterpenes

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	132016000072478	Italy		PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1758555	16C1003	France		PRODUCT NAME: BETULINE; REGISTRATION NO/DATE: EU/1/15/1069 20160118
1758555	C 2016 025	Romania		PRODUCT NAME: BETULINA(EXTRACT DIN SCOARTA DE MESTEACAN); NATIONAL AUTHORISATION NUMBER: EU/1/15/1069/001; DATE OF NATIONAL AUTHORISATION: 20160114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1069/001; DATE OF FIRST AUTHORISATION IN EEA: 20160114
1758555	C201630042	Spain		PRODUCT NAME: BETULINA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1069; DATE OF AUTHORISATION: 20160114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1069; DATE OF FIRST AUTHORISATION IN EEA: 20160114
1758555	PA2016023	Lithuania		PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114
1758555	1690031-8	Sweden		PRODUCT NAME: BETULIN; REG. NO/DATE: EU/1/15/1069 20160118

Market Dynamics and Financial Trajectory for Birch Triterpenes (Filsuvez)

Introduction to Birch Triterpenes

Birch triterpenes, marketed under the brand name Filsuvez, is a groundbreaking topical gel derived from birch bark extract. It has been approved by the FDA for the treatment of partial thickness wounds associated with dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB) in patients aged 6 months and older[1][3][5].

FDA Approval and Regulatory Milestones

The FDA approval of Filsuvez on December 19, 2023, marked a significant milestone in the treatment of epidermolysis bullosa (EB), a rare and debilitating genetic skin disease. This approval was based on the results of the EASE trial, a large global phase 3 trial that demonstrated the efficacy of birch triterpenes in promoting wound healing[1][3][5].

Market Need and Demand

Epidermolysis bullosa is a rare condition with limited treatment options, making the approval of Filsuvez a critical development for patients and their families. The lack of approved treatments for JEB, in particular, highlights the significant market need that Filsuvez addresses. This demand is expected to drive the adoption and use of Filsuvez, especially given its status as the first FDA-approved treatment for wounds associated with JEB[1][2][5].

Clinical Trial Outcomes and Efficacy

The EASE trial, which included 223 patients with EB, showed that Filsuvez significantly improved wound healing compared to the control gel. The primary endpoint of complete wound closure within 45 days was achieved with statistical significance, although some secondary endpoints did not reach statistical significance. These results underscore the clinical value of Filsuvez and are likely to influence its market acceptance[1][3][5].

Safety and Side Effects

While Filsuvez has demonstrated efficacy, it is not without side effects. Common adverse reactions include pruritus (itching), pain at the wound application site, and local hypersensitivity reactions such as urticaria and dermatitis. These side effects are relatively mild and manageable, which is crucial for maintaining patient compliance and market confidence[1][3][5].

Market Competition

The market for treatments of epidermolysis bullosa is relatively niche but growing due to advancements in research and development. Other treatments, such as those from Krystal Biotech (e.g., B-VEC), are in various stages of clinical development and regulatory review. However, Filsuvez currently holds a unique position as the first FDA-approved treatment for JEB, giving it a competitive edge in this segment[4].

Financial Trajectory

Revenue Potential

Given the lack of approved treatments for EB, particularly JEB, Filsuvez is poised to capture a significant share of the market. The rare disease designation and the critical need for effective treatments suggest a high revenue potential. The drug's ability to be administered at home and integrated into existing treatment regimens further enhances its market appeal and potential for widespread adoption[1][2][5].

Pricing and Reimbursement

The pricing strategy for Filsuvez will be crucial in determining its financial trajectory. As a treatment for a rare and severe condition, it is likely to be priced at a premium. Reimbursement policies, especially in the US and EU, will play a significant role in ensuring patient access and driving revenue. The support from advocacy groups and the recognition of the drug's value by regulatory bodies will be essential in securing favorable reimbursement terms[2][3].

Partnership and Funding

The development of Filsuvez was supported by various stakeholders, including the EB Research Partnership, which employs a venture philanthropy model to fund research. This model allows returns from successful therapies to be reinvested in additional EB research, potentially creating a sustainable funding cycle for future treatments[2].

Key Takeaways

• First FDA Approval: Filsuvez is the first FDA-approved treatment for wounds associated with JEB, marking a significant milestone in EB treatment.
• Market Need: The drug addresses a critical need for effective treatments in a rare and debilitating condition.
• Clinical Efficacy: The EASE trial demonstrated the efficacy of Filsuvez in promoting wound healing.
• Safety Profile: Common side effects are manageable, supporting patient compliance.
• Market Competition: Filsuvez holds a competitive edge as the first approved treatment for JEB.
• Financial Potential: High revenue potential due to the lack of approved treatments and the critical need for effective therapies.

FAQs

What is Filsuvez (birch triterpenes), and what is it used for?

Filsuvez is a topical gel derived from birch bark extract, approved for the treatment of partial thickness wounds associated with dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB) in patients aged 6 months and older.

How was Filsuvez approved, and what were the key clinical trial outcomes?

Filsuvez was approved based on the results of the EASE trial, a phase 3 clinical trial that showed significant improvement in wound healing compared to the control gel, with the primary endpoint of complete wound closure within 45 days achieved with statistical significance.

What are the common side effects of Filsuvez?

Common side effects include pruritus (itching), pain at the wound application site, and local hypersensitivity reactions such as urticaria and dermatitis.

How does Filsuvez compare to other treatments for epidermolysis bullosa?

Filsuvez is the first FDA-approved treatment for wounds associated with JEB, giving it a unique position in the market. Other treatments are in various stages of development and regulatory review.

What is the financial outlook for Filsuvez?

Given its unique approval status and the critical need for effective treatments in EB, Filsuvez is expected to have a high revenue potential. The drug's ability to be administered at home and integrated into existing treatment regimens further enhances its market appeal.

Sources

1. Pharmacy Times: FDA Approves Birch Triterpenes Topical Gel for Treatment for Adult & Pediatric Patients with JEB & DEB.
2. EB Research Partnership: FDA Approves FILSUVEZ® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older.
3. Wikipedia: Birch triterpenes.
4. Krystal Biotech INC: Form 10-K filed 02/26/2024.
5. Drugs.com: Filsuvez (birch triterpenes) FDA Approval History.

Last updated: 2024-12-17