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Last Updated: December 22, 2024

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE Drug Patent Profile


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When do Ketorolac Tromethamine And Phenylephrine Hydrochloride patents expire, and what generic alternatives are available?

Ketorolac Tromethamine And Phenylephrine Hydrochloride is a drug marketed by Lupin Ltd and is included in one NDA.

The generic ingredient in KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

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Summary for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

US Patents and Regulatory Information for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 210183-001 Jul 1, 2019 AT RX 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

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ketorolac Tromethamine and Phenylephrine Hydrochloride

Introduction

Ketorolac Tromethamine, often combined with Phenylephrine Hydrochloride, is a potent analgesic and anti-inflammatory drug widely used in various medical procedures, particularly in pain management and ophthalmic surgeries. This article delves into the market dynamics and financial trajectory of this drug, highlighting its current market size, growth prospects, regional performance, and the financial impact of its use.

Global Market Size and Growth Prospects

The global Ketorolac Tromethamine market is substantial and growing. As of 2024, the market size is estimated at USD 725.2 million and is projected to expand at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031, reaching USD 1,553.75 million by 2031[1].

Regional Market Performance

North America

North America dominates the Ketorolac Tromethamine market, accounting for approximately 40% of the global revenue, with a market size of USD 290.08 million in 2024. This region is expected to grow at a CAGR of 9.7% from 2024 to 2031. The growth is driven by increasing surgical procedures, rising chronic pain cases, and a robust pharmaceutical industry[1].

Europe

Europe is the fastest-growing region, with a market size of USD 217.56 million in 2024 and a projected CAGR of 10.0% from 2024 to 2031. The region's growth is attributed to the rising incidence of surgical procedures, an expanding geriatric population, and stringent regulatory requirements ensuring product quality and safety[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 166.80 million in 2024. It is expected to grow at a CAGR of 13.5% from 2024 to 2031, driven by increasing healthcare infrastructure and a growing demand for pain management solutions[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the market, with Latin America holding around 5% of the global revenue (USD 36.26 million in 2024) and the Middle East & Africa holding about 2% (USD 14.50 million in 2024). These regions are expected to grow at CAGRs of 10.9% and 11.2%, respectively, from 2024 to 2031[1].

Drivers of Market Growth

Increasing Pain Management Needs

The rise in acute and chronic pain conditions globally boosts the demand for effective analgesics like Ketorolac Tromethamine. This trend is particularly pronounced in regions with aging populations and increasing surgical interventions[3].

Surgical Procedures

An increase in surgical procedures, especially orthopedic and dental surgeries, drives the need for postoperative pain management. Ketorolac Tromethamine is often preferred due to its efficacy and safety profile[3].

Advancements in Formulations

Innovations in drug delivery systems, such as injectable forms, enhance the efficacy and patient compliance of Ketorolac Tromethamine. These advancements are expected to further propel market growth[3].

Regulatory Approvals

New approvals and expanded indications for Ketorolac Tromethamine can create significant opportunities for market expansion. Regulatory approvals play a crucial role in the drug's adoption and usage[3].

Financial Impact of Ketorolac Tromethamine Use

Cost Savings in Healthcare Settings

Studies have shown that the use of Ketorolac Tromethamine can lead to significant cost savings in healthcare settings. For instance, a study at the University of Utah Moran Eye Center found that the use of Omidria (a combination of Phenylephrine and Ketorolac) in cataract surgery reduced the need for pupillary dilation devices, resulting in cost savings of $106,225 per year in Ambulatory Surgery Centers (ASCs)[2].

Reduced Hospital Costs

A retrospective cohort study at LDS Hospital in Salt Lake City demonstrated that Ketorolac Tromethamine use was associated with reduced lengths of stay, lower usage of narcotic drugs, and fewer adverse events. This led to a statistically significant reduction in total hospital costs[5].

Financial Modeling in Cataract Surgery

In the context of cataract surgery, financial modeling has shown that while the use of Omidria increases facility costs in Hospital Outpatient Department (HOPD) settings due to lack of insurance reimbursement, it saves costs in ASC settings where it is separately reimbursed by insurance[2].

Challenges and Limitations

Regulatory Challenges

Strict regulations and approval processes from health authorities can hinder the introduction of new formulations or generics of Ketorolac Tromethamine. These regulatory hurdles can slow market growth[3].

Adverse Effects

Potential side effects such as gastrointestinal bleeding or kidney damage may limit the use and acceptance of Ketorolac Tromethamine among healthcare providers. These adverse effects can impact market demand[3].

Competition from Alternatives

The presence of other non-steroidal anti-inflammatory drugs (NSAIDs) and pain management options can affect the demand for Ketorolac Tromethamine. Market saturation with existing products and competition from alternative therapies are significant challenges[3].

Conclusion

The market for Ketorolac Tromethamine, often combined with Phenylephrine Hydrochloride, is poised for significant growth driven by increasing pain management needs, advancements in formulations, and regulatory approvals. While the drug offers substantial financial benefits in healthcare settings, it also faces challenges such as regulatory hurdles, potential adverse effects, and competition from alternative therapies.

Key Takeaways

  • The global Ketorolac Tromethamine market is projected to grow at a CAGR of 11.50% from 2024 to 2031.
  • North America and Europe are the leading regions, driven by increasing surgical procedures and a growing geriatric population.
  • The use of Ketorolac Tromethamine can lead to significant cost savings in healthcare settings.
  • Regulatory approvals and advancements in formulations are key drivers of market growth.
  • The drug faces challenges such as adverse effects, regulatory hurdles, and competition from alternatives.

FAQs

What is the current market size of Ketorolac Tromethamine?

The global Ketorolac Tromethamine market size is estimated at USD 725.2 million in 2024[1].

What is the projected growth rate of the Ketorolac Tromethamine market?

The market is expected to grow at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031[1].

Which regions dominate the Ketorolac Tromethamine market?

North America and Europe are the dominant regions, with North America accounting for around 40% of the global revenue and Europe being the fastest-growing region[1].

How does Ketorolac Tromethamine impact healthcare costs?

The use of Ketorolac Tromethamine can lead to significant cost savings by reducing the need for other medications, shortening hospital stays, and decreasing the use of pupillary dilation devices[2][5].

What are the main challenges facing the Ketorolac Tromethamine market?

The main challenges include regulatory hurdles, potential adverse effects, competition from alternative therapies, and market saturation[3].

Sources

  1. Cognitive Market Research: Ketorolac Tromethamine Market Report 2024 (Global Edition)
  2. IOVS: The Financial Impact of Phenylephrine/Ketorolac in Routine Cataract Surgery
  3. Verified Market Research: Ketorolac Tromethamine Market Trends, Size & Forecast
  4. Tandfonline: The clinical utility of new combination phenylephrine/ketorolac
  5. PubMed: Evaluation of the financial impact of ketorolac tromethamine therapy

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