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Last Updated: December 22, 2024

Rauwolfia serpentina root - Generic Drug Details


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What are the generic drug sources for rauwolfia serpentina root and what is the scope of patent protection?

Rauwolfia serpentina root is the generic ingredient in eight branded drugs marketed by Bowman Pharms, Phys Prods Va, Panray, Apothecon, Ferndale Labs, Pal Pak, Bundy, Halsey, Impax Labs, Ivax Sub Teva Pharms, Purepac Pharm, Pvt Form, Solvay, Tablicaps, Valeant Pharm Intl, Watson Labs, and Forest Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for rauwolfia serpentina root.

Summary for rauwolfia serpentina root
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US Patents and Regulatory Information for rauwolfia serpentina root

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey RAUWOLFIA SERPENTINA rauwolfia serpentina root TABLET;ORAL 080498-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bundy RAUWOLFIA SERPENTINA rauwolfia serpentina root TABLET;ORAL 009477-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Phys Prods Va HYSERPIN rauwolfia serpentina root TABLET;ORAL 010581-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Purepac Pharm RAUWOLFIA SERPENTINA rauwolfia serpentina root TABLET;ORAL 080842-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bundy RAUWOLFIA SERPENTINA rauwolfia serpentina root TABLET;ORAL 009477-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay RAUWOLFIA SERPENTINA rauwolfia serpentina root TABLET;ORAL 080500-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Impax Labs RAUWOLFIA SERPENTINA rauwolfia serpentina root TABLET;ORAL 009273-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Rauwolfia serpentina root Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rauwolfia Serpentina Root

Introduction

Rauwolfia serpentina, commonly known as Sarpaghanda or Snakeroot, is a medicinal plant with a rich history in traditional medicine, particularly in Ayurveda. The root of this plant is highly valued for its therapeutic properties, including the treatment of hypertension, mental disorders, and various other ailments. Here, we delve into the market dynamics and financial trajectory of Rauwolfia serpentina root.

Global Demand and Market Trends

The demand for Rauwolfia serpentina root is significant, driven by its use in both traditional and modern medicine. According to the World Health Organization, about 65% of the world's population uses medicinal plants for health care, which includes Rauwolfia serpentina[1].

International Market

The root is highly sought after in international markets, particularly in countries like the USA, China, and European nations. India has historically been a major supplier, but other countries such as Nepal, Pakistan, Sri Lanka, and Thailand also contribute to the global supply[4].

Price Trends

The price of Rauwolfia serpentina root has been consistently increasing over the years. In Nepal, for example, the market price is around US$ 12 per kilogram, with prices in European countries like Germany reaching as high as US$ 3.26 per kilogram[1]. This upward trend is indicative of the growing demand and limited supply.

Trade Channels and Export

Major Exporters

India has traditionally dominated the export of Rauwolfia serpentina roots, with significant quantities also exported from Nepal, Pakistan, and other Asian countries. The export figures from India have been substantial, with over 400 metric tonnes exported between 1963-1968 to countries like Malaysia, Japan, and others[4].

Export Regulations

To conserve the natural growth of Rauwolfia serpentina, the Indian government restricted the export of crude drug from wild sources in 1981-1982. Despite these regulations, reports of illegal export and smuggling of Rauwolfia roots continue to surface[4].

Financial Aspects

Revenue Generation

The export of Rauwolfia serpentina roots generates significant revenue for the countries involved. For instance, India's export figures for Rauwolfia roots and preparations showed a fluctuating but substantial financial value, ranging from 83.5 thousand to 901.4 thousand Indian Rupees between 1978-1983[4].

Market Value

The market value of Rauwolfia serpentina is not only reflected in its export figures but also in its domestic market. In Nepal, companies like HPPCL, Gorkha Ayurveda Company Limited, Dabur Nepal, and Singha Darbar Vaidhyakhana are major buyers, paying varying royalties and prices per kilogram[1].

Challenges and Opportunities

Conservation and Sustainability

Rauwolfia serpentina is listed on the IUCN's endangered list due to poor traditional methods of propagation and over-harvesting. The low germination rate and limited success of root cutting methods exacerbate the issue. However, the root stump method, though effective, is not scalable[1].

Biotechnological Advancements

Biotechnological methods offer a promising solution for sustainable production. The hairy root component of Rauwolfia serpentina has shown remarkable capacity for regeneration and biosynthetic potential, making it a focus for biotechnological research[3].

Pharmacological and Therapeutic Value

Therapeutic Uses

Rauwolfia serpentina root is rich in alkaloids, particularly reserpine, rescinnamine, and deserpidine, which are used in treating hypertension, schizophrenia, and other central nervous system disorders. It also has antibacterial, antioxidant, and antineoplastic properties[2][3][5].

Economic Impact of Therapeutic Value

The therapeutic value of Rauwolfia serpentina translates into economic benefits through the pharmaceutical industry. The demand for its alkaloids drives the market, and companies invest significantly in research and development to harness its medicinal properties.

Legal and Regulatory Framework

National Regulations

In India, Rauwolfia serpentina is included in Part A of Schedule I of the Export (Trade) Control Order-1988, prohibiting the export of live specimens, roots, and other derivatives. Similar regulations exist in other countries to protect the species from over-exploitation[4].

International Protection

While there are no international protections specifically for Rauwolfia serpentina, the species is recognized as needing strict regulation to ensure its survival. The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) highlights the need for additional protection measures[4].

Future Outlook

Market Growth

The increasing demand for natural and traditional medicines is expected to drive the market for Rauwolfia serpentina root. As more countries adopt holistic health practices, the global market is likely to expand.

Sustainability Efforts

Efforts to cultivate Rauwolfia serpentina sustainably and implement biotechnological methods for propagation are crucial for maintaining a steady supply. This could mitigate the risks associated with over-harvesting and ensure a stable financial trajectory.

Key Takeaways

  • High Demand: Rauwolfia serpentina root is in high demand globally, driven by its therapeutic properties.
  • Price Trends: The price of the root is increasing due to limited supply and high demand.
  • Export Regulations: Strict regulations are in place to conserve the species, but illegal trade remains a challenge.
  • Financial Value: The root generates significant revenue through exports and domestic sales.
  • Sustainability: Biotechnological advancements are essential for sustainable production and conservation.
  • Therapeutic Value: The root's pharmacological properties drive its economic value in the pharmaceutical industry.

FAQs

What are the primary therapeutic uses of Rauwolfia serpentina root?

Rauwolfia serpentina root is primarily used in the treatment of hypertension, schizophrenia, and other central nervous system disorders. It also has antibacterial, antioxidant, and antineoplastic properties.

Which countries are major exporters of Rauwolfia serpentina root?

India has historically been the major exporter, but other significant exporters include Nepal, Pakistan, Sri Lanka, and Thailand.

Why is Rauwolfia serpentina listed as endangered?

Rauwolfia serpentina is listed as endangered due to poor traditional methods of propagation and over-harvesting, which have led to a significant decline in its natural population.

What are the biotechnological advancements in Rauwolfia serpentina cultivation?

Biotechnological methods, such as the use of hairy root components, have shown promise in regenerating and sustaining Rauwolfia serpentina plants, offering a potential solution for sustainable production.

What are the regulatory measures in place to protect Rauwolfia serpentina?

In India, Rauwolfia serpentina is included in Part A of Schedule I of the Export (Trade) Control Order-1988, prohibiting the export of live specimens, roots, and other derivatives. Similar regulations exist in other countries to protect the species.

Sources

  1. Gaire et al.: Predicting the potential distribution, trade, and conservation of Rauvolfia serpentina in Nepal - APPLIED ECOLOGY AND ENVIRONMENTAL RESEARCH 20(6):4999-5022.
  2. MDPI: A Comparative Antibacterial, Antioxidant, and Antineoplastic Potential of Rauwolfia serpentina (L.) Leaf Extract with Its Biologically Synthesized Gold Nanoparticles (R-AuNPs).
  3. DrugBank: Rauwolfia serpentina root: Uses, Interactions, Mechanism of Action.
  4. CITES: Rauvolfia serpentina.
  5. IJARSCT: Pharmacological Review on Rauwolfia serpentina.

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