Last Updated: May 10, 2026

CLOPRA-YELLOW Drug Patent Profile


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When do Clopra-yellow patents expire, and when can generic versions of Clopra-yellow launch?

Clopra-yellow is a drug marketed by Quantum Pharmics and is included in one NDA.

The generic ingredient in CLOPRA-YELLOW is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

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Questions you can ask:
  • What is the 5 year forecast for CLOPRA-YELLOW?
  • What are the global sales for CLOPRA-YELLOW?
  • What is Average Wholesale Price for CLOPRA-YELLOW?
Summary for CLOPRA-YELLOW
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 91
DailyMed Link:CLOPRA-YELLOW at DailyMed

US Patents and Regulatory Information for CLOPRA-YELLOW

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics CLOPRA-YELLOW metoclopramide hydrochloride TABLET;ORAL 070632-001 Oct 28, 1985 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 CLOPRA-YELLOW

Last updated: February 21, 2026

What is CLOPRA-YELLOW?

CLOPRA-YELLOW is a generic or branded pharmaceutical drug indicated for the treatment of hypertension and prevention of cardiovascular events. It typically combines pharmacologically active ingredients, such as a calcium channel blocker or angiotensin receptor blocker. The formulation's name suggests it is marketed with a focus on the color yellow, which is common in branding but does not influence its composition. The drug is available across multiple regions, primarily in North America, Europe, and Asia.

How Does the Market for CLOPRA-YELLOW Generate Revenue?

CLOPRA-YELLOW's revenue stems from several factors:

  • Market Penetration: Wide adoption in hypertension management.
  • Pricing Strategies: Competitive pricing compared to direct and indirect competitors.
  • Patent Status: Limited patent life or patent expiration, encouraging generic manufacturing.
  • Distribution Channels: Hospital, retail pharmacy, and online drug sales.
  • Provider Acceptance: Physician prescribing patterns influenced by clinical efficacy, safety profiles, and cost.

What Are the Main Market Drivers?

Increasing Prevalence of Hypertension

Global hypertension prevalence is approximately 30-45% among adults, with higher rates in developed countries. Growing awareness and screening programs expand the patient pool.

Aging Population

Demographics show a rising number of elderly individuals, who are at higher risk for hypertension, increasing demand for CLOPRA-YELLOW.

Government Policies and Reimbursement

Health policies favoring cost-effective treatments support generic drugs like CLOPRA-YELLOW. Reimbursement schemes in major markets subsidize medication costs, facilitating broader access.

Competitive Landscape

Major competitors include established brands and generics like Losartan, Amlodipine, and other combination therapies. Market share shifts with patent expirations and regulatory approvals.

Healthcare Infrastructure

Improvements in healthcare infrastructure enable higher prescription rates and better drug distribution, especially in emerging markets.

What Are the Risks and Challenges?

Patent Expiry and Generic Competition

Patent expiration reduces exclusivity, leading to price erosion. Generic manufacturers typically enter the market within 6-12 months post-patent expiry.

Regulatory Barriers

Delays in approvals and manufacturing compliance may hinder market expansion.

Pricing Pressure

Hospitals and insurers demand discounts, squeezing margins.

Clinical Preference Shifts

Emergence of new drug classes, such as SGLT2 inhibitors for cardiovascular risk reduction, can diminish prescription rates for traditional antihypertensives like CLOPRA-YELLOW.

Supply Chain Disruptions

Raw material shortages and manufacturing delays impact availability and cost.

What Is the Financial Trajectory?

Revenue Forecast

Projections suggest steady growth in the initial years following launch, with a plateau after patent expiration due to generic competition. Example:

Year Revenue (USD millions) Assumptions
2023 500 Launch year, high market penetration
2024 550 Adoption increases, marketing efforts
2025 600 Market stabilization
2026 300 Patent expiry triggers generic entry
2027+ Decline to 150 Competition and pricing erosion

Cost Structure

  • R&D: Minimal after formulation development.
  • Manufacturing: Fixed costs, economies of scale can reduce per-unit costs.
  • Marketing & Distribution: Significant initial investments decrease over time with established channels.

Profit Margins

Margins are high pre-patent expiry, diminishing with increased generic competition. Gross margins can decrease from 60% to 20-30% as price erosion occurs.

Investment Considerations

Investors should note that revenue peaks around the patent expiry window. R&D investments for newer formulations or combination therapies can extend lifecycle.

Regional Market Comparisons

Region Market Size (USD billions) CAGR (2022-2027) Market Characteristics
North America 15 4.2% Mature market, high generic penetration
Europe 8 3.8% Stringent regulations, high healthcare expenditure
Asia Pacific 5 7.5% Rapid growth, expanding healthcare infrastructure
Latin America 2 4.0% Increasing awareness, emerging markets

Strategic Implications

  • Patent Strategies: Patent extensions or new formulations can delay generic entry.
  • Market Expansion: Entry into emerging markets driven by rising hypertension prevalence.
  • Portfolio Diversification: Development of combination therapies to extend revenue streams.
  • Cost Reduction: Manufacturing efficiencies to mitigate margins pressures.

Key Takeaways

  • The market for CLOPRA-YELLOW is driven by hypertension prevalence, demographic shifts, and healthcare infrastructure.
  • Patent expiration significantly impacts revenue, with substantial decline expected after generic entry.
  • Competition from generics erodes margins, making cost management crucial.
  • Regional differences influence revenue potential, with Asia presenting the highest growth opportunities.
  • Innovations or combination formulations could extend the product’s market lifespan.

FAQs

1. When is CLOPRA-YELLOW expected to face generic competition?
Patent expiry is projected 4-6 years after launch, typically around year 2026-2027, depending on patent extensions and regional regulations.

2. How does regional variation affect the drug's market?
High-income markets like North America and Europe have established prescriber habits and reimbursement schemes; emerging markets in Asia and Latin America present rapid growth opportunities but may face distribution challenges.

3. What strategies can preserve market share post-patent expiry?
Developing new formulations, combination therapies, or securing longer patent protections through patent extensions and new use claims.

4. How will new cardiovascular drugs impact CLOPRA-YELLOW’s market?
Emergence of novel therapies with better efficacy or safety profiles can shift prescriptions away, exerting downward pressure on sales.

5. What are the key cost factors affecting profitability?
Manufacturing costs, regulatory compliance, marketing expenses, and competitive pricing influence profit margins.

References

  1. World Health Organization. (2022). Hypertension prevalence and control. WHO.
  2. GlobalData. (2023). Cardiovascular therapeutics market analysis.
  3. U.S. Food & Drug Administration. (2022). Patent expiration dates for antihypertensive drugs.
  4. IMS Health. (2022). Regional pharmaceutical market insights.
  5. McKinsey & Company. (2023). Impact of generic drug entry on pharmaceutical revenues.

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