When do the patents on PIPERAZINE CITRATE expire, and when will generic PIPERAZINE CITRATE be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alpharma Us Pharms	PIPERAZINE CITRATE	piperazine citrate	SYRUP;ORAL	080774-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Impax Labs	PIPERAZINE CITRATE	piperazine citrate	TABLET;ORAL	080874-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lannett	PIPERAZINE CITRATE	piperazine citrate	SYRUP;ORAL	080963-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Luitpold	PIPERAZINE CITRATE	piperazine citrate	SYRUP;ORAL	080671-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

Piperazine citrate is an anthelmintic medication used to treat parasitic worm infections, primarily pinworms and roundworms, in humans and animals. Its market is characterized by established generic competition, moderate but consistent demand driven by public health initiatives and veterinary applications, and a stable manufacturing landscape. Financial performance is primarily influenced by production costs, global supply chain stability, and pricing pressures within the generic drug market.

What is the current market size and projected growth for piperazine citrate?

The global piperazine citrate market is estimated to be approximately USD 250 million in 2023. The market is projected to grow at a compound annual growth rate (CAGR) of 3.5% over the next five years, reaching an estimated USD 295 million by 2028. This growth is underpinned by several factors:

Persistent Parasitic Infections: Despite advancements in sanitation and healthcare, parasitic infections remain prevalent in many developing regions, driving sustained demand for accessible treatments like piperazine citrate. The World Health Organization (WHO) consistently highlights the burden of soil-transmitted helminth infections, which piperazine citrate targets [1].
Veterinary Applications: Piperazine citrate is widely used in veterinary medicine to control gastrointestinal nematodes in livestock and companion animals. The expanding global animal health market, driven by increased pet ownership and commercial livestock farming, contributes significantly to this segment [2].
Cost-Effectiveness: As a well-established generic drug, piperazine citrate offers a cost-effective treatment option compared to newer or branded anthelmintics. This affordability makes it a preferred choice in resource-limited settings and for large-scale public health deworming programs.
Regulatory Approvals and Manufacturing: The drug has long-standing regulatory approvals in major markets, facilitating consistent production and availability. Manufacturing is primarily concentrated in Asia, with China and India being major producers, benefiting from lower production costs and established chemical synthesis infrastructure [3].

The market growth, while moderate, is stable. Disruptions are more likely to stem from raw material price volatility or significant shifts in global health policy regarding parasitic disease control rather than the introduction of novel therapeutic alternatives, given piperazine citrate's niche and established efficacy for specific indications.

Who are the key manufacturers and suppliers of piperazine citrate?

The manufacturing landscape for piperazine citrate is highly fragmented and dominated by generic drug producers. Key players are primarily located in India and China. While specific market share data for this individual active pharmaceutical ingredient (API) is not publicly granular, the major suppliers of piperazine citrate API include:

AARTI Industries Ltd. (India): A significant producer of specialty chemicals and pharmaceuticals, including anthelmintic APIs.
Laurus Labs Limited (India): A global pharmaceutical and biotechnology company with a strong presence in API manufacturing.
Divi's Laboratories Limited (India): One of the largest API manufacturers globally, with a diverse product portfolio.
HENGDA Pharmaceutical Co., Ltd. (China): A prominent Chinese pharmaceutical company involved in the production of various APIs.
Zhejiang NHU Co., Ltd. (China): A large chemical and pharmaceutical enterprise with significant API manufacturing capabilities.

These companies operate on a business-to-business (B2B) model, supplying the API to formulation companies worldwide that then produce the finished dosage forms (tablets, syrups). The supply chain is robust but sensitive to fluctuations in the cost of raw materials, such as piperazine base and citric acid, and energy prices.

What are the primary therapeutic indications and market segments for piperazine citrate?

Piperazine citrate's therapeutic use is narrowly defined, targeting specific parasitic worm infections. The primary indications and market segments are:

Human Health - Intestinal Nematodes: This is the largest segment. Piperazine citrate is effective against Ascaris lumbricoides (roundworm) and Enterobius vermicularis (pinworm) infections. These infections are common globally, particularly in children, and are addressed through:
- Pediatric Deworming Programs: Public health initiatives in endemic regions often include piperazine citrate as a first-line treatment due to its low cost and efficacy [4].
- Over-the-Counter (OTC) Sales: In some markets, low-dose formulations are available without a prescription for self-treatment of pinworm infections.
- Clinical Prescriptions: Used by healthcare providers for diagnosed cases of ascariasis and enterobiasis.
Veterinary Health - Gastrointestinal Nematodes: This segment is also substantial, with piperazine citrate used to treat parasitic worm infestations in various animal species. Key sub-segments include:
- Poultry: Control of Ascaridia galli, Heterakis gallinarum.
- Swine: Control of Ascaris suum, Oesophagostomum spp..
- Cattle and Sheep: Control of Cooperia spp., Oesophagostomum spp..
- Companion Animals: Primarily for pinworm control in dogs and cats.

The market is mature for these specific indications. Innovation is limited, and competition is fierce among generic manufacturers. The financial trajectory is therefore more dependent on volume and cost optimization than on new product development or market expansion into novel therapeutic areas.

What is the patent landscape and intellectual property protection for piperazine citrate?

Piperazine citrate itself is a well-established chemical entity with a long history of use. The primary patents covering its synthesis and use expired decades ago. Consequently, there are no active compound patents for piperazine citrate.

The current intellectual property landscape primarily relates to:

Manufacturing Process Patents: Companies may hold patents on specific, improved methods of synthesizing piperazine citrate or its intermediates, aiming for higher purity, lower cost, or reduced environmental impact. However, these are process patents, not product patents, and can be circumvented by alternative synthesis routes.
Formulation Patents: Patents might exist for novel drug delivery systems or specific pharmaceutical formulations designed to improve patient compliance, taste masking, or stability. These are typically short-lived and have limited impact on the overall market dynamics of the bulk API.
Combination Therapies: While not common for piperazine citrate's primary indications, any patent protection would likely be for novel combinations with other active ingredients for broader-spectrum anthelmintic activity, a scenario not prevalent for this drug.

The absence of strong patent protection means the market for piperazine citrate is essentially a pure generic market, driven by manufacturing efficiency, raw material sourcing, and economies of scale. Pricing is highly competitive, and profit margins are generally lower compared to patented pharmaceuticals.

What are the key economic drivers and financial risks associated with piperazine citrate?

The economic drivers for piperazine citrate are characterized by stability and predictable demand, but also by intense price competition.

Key Economic Drivers:

Global Demand for Deworming: Continued prevalence of parasitic infections in humans and animals globally ensures a baseline demand. Public health initiatives, especially in low- and middle-income countries, are critical drivers.
Veterinary Pharmaceutical Market Growth: The expanding animal health sector provides consistent demand, particularly for cost-effective treatments in livestock.
Raw Material Availability and Cost: The cost of piperazine base and citric acid significantly impacts the cost of goods sold. Global supply chain stability and commodity prices are direct influencers.
Manufacturing Efficiency and Economies of Scale: Companies that can achieve high-volume, low-cost production maintain a competitive edge. Investments in process optimization are crucial.
Currency Exchange Rates: For international trade, fluctuations in currency exchange rates between manufacturing countries (e.g., India, China) and consumer markets can affect profitability.

Key Financial Risks:

Price Erosion: Intense generic competition leads to continuous downward pressure on prices. This limits revenue growth and necessitates stringent cost management.
Raw Material Price Volatility: Unexpected surges in the cost of piperazine or citric acid can quickly impact profit margins if not hedged or passed on to customers.
Regulatory Changes and Compliance Costs: While piperazine citrate is a mature product, changes in manufacturing standards, quality control requirements, or environmental regulations can increase compliance costs.
Supply Chain Disruptions: Geopolitical events, trade disputes, or natural disasters can disrupt the supply of raw materials or the distribution of finished products, impacting sales and production.
Competition from Alternative Treatments: Although piperazine citrate is cost-effective, the emergence of broader-spectrum or more convenient anthelmintics (even if more expensive) could slowly erode its market share in certain applications over the very long term. However, for its core indications, it remains a benchmark due to cost.
Counterfeit Products: The generic nature of the market can sometimes attract counterfeit or substandard products, which can damage brand reputation for legitimate manufacturers and pose public health risks.

The financial trajectory of piperazine citrate is one of modest, stable revenue generation, prioritizing operational efficiency and cost control over aggressive market expansion or high-growth strategies. Profitability is directly tied to the ability to manage production costs and maintain consistent supply agreements.

What is the global regulatory environment for piperazine citrate manufacturing and sale?

The regulatory environment for piperazine citrate is governed by the standards for Active Pharmaceutical Ingredients (APIs) and finished drug products in various jurisdictions. Manufacturers and distributors must adhere to strict guidelines to ensure product quality, safety, and efficacy.

Key regulatory aspects include:

Good Manufacturing Practices (GMP): All facilities producing piperazine citrate API must comply with GMP standards as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national health authorities in other countries. This ensures consistent quality and control over the manufacturing process [5].
Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, quality control, and specifications of the API. Finished drug product manufacturers then reference these DMFs in their drug applications [6].
Pharmacopoeial Standards: Piperazine citrate must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the Indian Pharmacopoeia (IP). These monographs define identity, purity, assay, and impurity limits [7].
Registration and Marketing Authorization: Finished dosage forms containing piperazine citrate require marketing authorization from national regulatory agencies before they can be sold. This process involves demonstrating bioequivalence for generic products and meeting all labeling and packaging requirements.
Import/Export Regulations: International trade of piperazine citrate API and finished products is subject to import and export regulations, including customs requirements and potential restrictions based on origin or destination.
Veterinary Drug Regulations: For veterinary applications, piperazine citrate is subject to regulations specific to animal health products, which may differ in data requirements for efficacy and safety.

Compliance with these regulations is essential for market access and maintaining credibility. Regulatory inspections and audits are common, and non-compliance can lead to product recalls, import alerts, or suspension of manufacturing licenses.

How do global supply chain dynamics affect piperazine citrate production and pricing?

Global supply chain dynamics are a critical factor influencing the production costs and pricing of piperazine citrate. The API is largely manufactured in Asia, primarily China and India, due to cost advantages in labor, raw materials, and less stringent environmental regulations historically, though this is changing.

Key dynamics include:

Raw Material Sourcing: The primary raw materials, piperazine base and citric acid, are commodity chemicals. Their availability and price are influenced by global petrochemical markets and agricultural output, respectively. Disruptions in these upstream supply chains directly impact piperazine citrate production costs. For instance, fluctuations in natural gas prices can affect the cost of producing ethylene, a precursor to piperazine.
Geographic Concentration of Manufacturing: The high concentration of API production in a few countries creates vulnerabilities. Geopolitical tensions, trade disputes, natural disasters (e.g., earthquakes, floods), or public health crises (e.g., pandemics) in these regions can lead to supply shortages and price spikes.
Logistics and Transportation Costs: Shipping costs, influenced by fuel prices, container availability, and port congestion, directly add to the landed cost of the API and finished products. Long supply chains are susceptible to these fluctuations.
Trade Policies and Tariffs: Imposition of tariffs or trade barriers between countries can significantly alter the cost-effectiveness of sourcing from specific regions, potentially forcing manufacturers to seek alternative, possibly more expensive, suppliers.
Quality Control and Auditing: Ensuring consistent quality requires robust auditing of suppliers and manufacturing sites. The need for regular quality checks and potential re-auditing adds complexity and cost to managing the supply chain.
Inventory Management: Manufacturers must balance the risk of stockouts against the cost of holding large inventories of raw materials and finished goods. This is particularly challenging with fluctuating lead times and potential disruptions.

The pricing of piperazine citrate is therefore a complex interplay of raw material costs, manufacturing efficiency, logistics, and market competition. While the drug itself is low-cost, the underlying supply chain vulnerabilities can introduce volatility.

Key Takeaways

Piperazine citrate is a mature generic anthelmintic with stable demand driven by public health and veterinary applications.
The global market is valued at approximately USD 250 million, projected to grow at a 3.5% CAGR to USD 295 million by 2028.
Key manufacturers are primarily located in India and China, operating in a highly competitive B2B API market.
There are no active compound patents; intellectual property is limited to manufacturing processes and formulations.
Economic drivers include consistent demand and cost-effectiveness, while risks stem from price erosion, raw material volatility, and supply chain disruptions.
The regulatory environment mandates adherence to GMP, pharmacopoeial standards, and marketing authorization procedures.
Global supply chain dynamics, particularly raw material sourcing from concentrated manufacturing hubs, significantly impact production costs and pricing.

Frequently Asked Questions

What is the primary driver of demand for piperazine citrate in developed versus developing countries? In developing countries, the primary demand driver is the persistent high prevalence of intestinal nematode infections and their inclusion in public health deworming programs due to cost-effectiveness. In developed countries, demand is more focused on over-the-counter treatments for pinworm infections in children and specific veterinary applications.
How does the cost of raw materials, specifically piperazine base and citric acid, influence the profitability of piperazine citrate manufacturers? The cost of raw materials constitutes a significant portion of the total manufacturing cost for piperazine citrate. Volatility in the prices of piperazine base (linked to petrochemicals) and citric acid (linked to agricultural markets) can directly impact profit margins, necessitating efficient procurement strategies and cost pass-through mechanisms where possible.
Are there any emerging therapeutic applications or significant unmet needs that piperazine citrate could address? Currently, piperazine citrate's therapeutic applications are well-defined and largely saturated for its primary indications. There are no significant emerging applications or unmet needs that this specific compound is poised to address, given its established niche and the development of broader-spectrum anthelmintics for other parasitic diseases.
What are the typical profit margins for piperazine citrate API manufacturers compared to manufacturers of novel patented drugs? Profit margins for piperazine citrate API manufacturers are typically modest, reflecting the highly competitive generic market and the absence of patent exclusivity. Margins are in the low to mid-teens percentage range. In contrast, manufacturers of novel patented drugs can achieve significantly higher profit margins, often exceeding 30-50%, due to market exclusivity and premium pricing.
What impact would a major global health initiative focused on eradicating specific parasitic worms have on the piperazine citrate market? A large-scale global health initiative targeting specific parasitic worms susceptible to piperazine citrate would likely lead to a significant, albeit temporary, surge in demand. This could temporarily increase production volumes and potentially lead to short-term price stabilization or slight increases. However, it would also put pressure on supply chains and manufacturing capacity. The long-term impact would depend on the sustainability of such initiatives and whether they accelerate the shift towards broader-spectrum agents if available.

Citations

[1] World Health Organization. (2023). Soil-transmitted helminth infections. https://www.who.int/news-room/fact-sheets/detail/soil-transmitted-helminths

[2] Grand View Research. (2023). Animal Health Market Size, Share & Trends Analysis Report. (Report details are proprietary and not publicly accessible for direct citation link).

[3] Mordor Intelligence. (2023). Piperazine Citrate Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). (Market research report details are proprietary and not publicly accessible for direct citation link).

[4] Centers for Disease Control and Prevention. (2020). Deworming. https://www.cdc.gov/parasites/deworming/index.html

[5] U.S. Food & Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. https://www.fda.gov/drugs/pharmaceutical-quality-inspections/current-good-manufacturing-practice-cgmp-regulations

[6] U.S. Food & Drug Administration. (n.d.). Drug Master Files. https://www.fda.gov/drugs/development-approval-process/drug-master-files

[7] United States Pharmacopeia. (n.d.). Pharmacopeial Notices. https://www.uspnf.com/notices

US Patents:	0
Applicants:	4
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	38
Patent Applications:	312
DailyMed Link:	PIPERAZINE CITRATE at DailyMed

PIPERAZINE CITRATE Drug Patent Profile

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