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Last Updated: March 26, 2026

Cyclizine lactate - Generic Drug Details


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What are the generic sources for cyclizine lactate and what is the scope of patent protection?

Cyclizine lactate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for cyclizine lactate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 21
DailyMed Link:cyclizine lactate at DailyMed
Medical Subject Heading (MeSH) Categories for cyclizine lactate
Anatomical Therapeutic Chemical (ATC) Classes for cyclizine lactate

US Patents and Regulatory Information for cyclizine lactate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline MAREZINE cyclizine lactate INJECTABLE;INJECTION 009495-001 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

Market Dynamics and Financial Trajectory for Cyclizine Lactate

Last updated: February 24, 2026

What Is Cyclizine Lactate and Its Medical Use?

Cyclizine lactate is an antihistamine primarily used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness, vertigo, and postoperative recovery. It belongs to the piperazine class of antihistamines and functions by blocking H1 receptors in the central nervous system.

Market Size and Growth Drivers

The global market for antiemetic drugs, including cyclizine lactate, is estimated at approximately USD 2.5 billion in 2022. The compound's market share remains modest compared to first-line drugs like ondansetron and promethazine but maintains a niche presence due to its favorable side-effect profile and specific use cases.

Potential growth drivers include:

  • Increased incidence of nausea related to chronic conditions such as migraines and chemotherapy.
  • Rising global surgical procedures contributing to demand for postoperative antiemetics.
  • Growing awareness of motion sickness management in the travel and military sectors.

Competitive Landscape

Cyclizine lactate faces competition from:

  • First-generation antihistamines (meclizine, promethazine)
  • 5-HT3 receptor antagonists (ondansetron, granisetron)
  • Neurokinin-1 receptor antagonists (aprepitant)

These drugs dominate the antiemetic space, especially in developed markets, limiting cyclizine's prevalence.

Patents and Regulatory Status

Most patents on cyclizine formulations expired by the early 2000s. Currently, it exists as a generic medication in various markets, leading to low manufacturing barriers and price competition.

Regulatory approvals span:

  • United States: No FDA approval for prescription use; available over-the-counter (OTC) in some formulations.
  • European Union: Approved as a prescription drug for vertigo and nausea.
  • Asian markets: Widely used, with some countries having over-the-counter access.

Manufacturing and Supply Chain

Cyclizine lactate is synthesized via chemical processes that are straightforward, resulting in affordable production costs. Key manufacturing countries include India, China, and some European nations, which supply both generic formulations and bulk ingredients.

Pricing and Revenue Projections

Generic cyclizine lactate tablets typically retail at USD 0.05–0.10 per tablet in developed markets. The market's mature nature and presence of generics suppress pricing, limiting profit margins.

Projected revenues for cyclizine-specific products are expected to remain flat or decline slightly due to:

  • Saturated markets in developed countries.
  • Competition from more effective or better-known drugs.
  • Regulatory preference shifting toward newer antiemetics in some regions.

In emerging markets, growth may occur as regulations liberalize and awareness increases, with potential annual growth rates (CAGR) of 1–2% over the next five years.

Patent and Regulatory Trends Impacting Financial Trajectory

Patent expirations facilitated price erosion. No recent patents are active for cyclizine lactate, reducing exclusivity opportunities and limiting investment incentives.

Emerging regulatory trends favoring newer, targeted therapies might restrain demand. However, the drug's low-cost profile sustains its use in low-income regions.

Investment and R&D Activity

Limited R&D activity exists around cyclizine lactate, with most efforts directed toward improved formulations rather than novel uses. New indications are rarely explored due to the availability of established alternatives.

Key Factors Affecting Financial Performance

Factor Impact
Patent expiry Lowers pricing power
Competition Limits market share
R&D investment Minimal, constrains innovation
Regulatory environment Drives adoption in some markets

Conclusions

Cyclizine lactate's market remains stable but limited. Its low-cost manufacturing and generic status restrict profitability. Growth opportunities depend primarily on expanding use in underserved markets or developing new formulations.

Key Takeaways

  • The drug has a niche role primarily in motion sickness and vertigo.
  • Patent expiration has led to price erosion.
  • Competition from newer antiemetics constrains market share.
  • Growth potential persists in emerging markets and specific clinical indications.
  • Limited R&D activity restricts product innovation.

FAQs

1. Why is cyclizine lactate not widely promoted in developed markets?
It lacks recent patent protection, faces competition from more effective antiemetics, and regulatory preferences favor newer drugs.

2. Can cyclizine lactate be used for chemotherapy-induced nausea?
While sometimes used off-label, evidence favors newer 5-HT3 antagonists with proven efficacy in chemotherapy settings.

3. What is the typical annual revenue for cyclizine lactate products?
Estimated at less than USD 100 million globally, dominated by generic sales in low- and middle-income countries.

4. Are there developments to improve cyclizine lactate formulations?
R&D focus on this compound is minimal; most efforts aim at alternative antiemetics with better efficacy profiles.

5. What factors could revive interest in cyclizine lactate?
Introduction of new formulations, combination therapies, or off-label use expansions could stabilize or slightly increase demand.


References

[1] Market Watch. (2022). Global antiemetics market size.
[2] European Medicines Agency. (2023). Approved uses of cyclizine.
[3] Indian Pharmaceutical Market. (2022). Generic drug production data.
[4] U.S. FDA. (2022). OTC availability of antihistamines.

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