Ketorolac tromethamine - Generic Drug Details

What are the generic sources for ketorolac tromethamine and what is the scope of freedom to operate?

Ketorolac tromethamine is the generic ingredient in nine branded drugs marketed by Alembic, Amphastar Pharm, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz, Steriscience Speclts, Sun Pharm, Wockhardt, Wockhardt Bio Ag, Roche Palo, Abbvie, Allergan, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Zyla, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus Lifesciences, Lupin Ltd, and Rayner Surgical, and is included in sixty-four NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine has sixty-eight patent family members in twenty-five countries.

There are sixteen drug master file entries for ketorolac tromethamine. Sixty-six suppliers are listed for this compound.

Summary for ketorolac tromethamine

International Patents:	68
US Patents:	19
Tradenames:	9
Applicants:	41
NDAs:	64
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	108
Patent Applications:	6,179
Drug Prices:	Drug price trends for ketorolac tromethamine
Drug Sales Revenues:	Drug sales revenues for ketorolac tromethamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ketorolac tromethamine
What excipients (inactive ingredients) are in ketorolac tromethamine?	ketorolac tromethamine excipients list
DailyMed Link:	ketorolac tromethamine at DailyMed

See drug prices for ketorolac tromethamine

See drug sales revenues for ketorolac tromethamine

Recent Clinical Trials for ketorolac tromethamine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Calgary	Phase 3
Canadian Institutes of Health Research (CIHR)	Phase 3
University of Miami	Phase 2

See all ketorolac tromethamine clinical trials

Pharmacology for ketorolac tromethamine

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for ketorolac tromethamine

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ketorolac tromethamine

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRIX	Nasal Spray	ketorolac tromethamine	15.75 mg/spray	022382	1	2012-03-12
ACUVAIL	Ophthalmic Solution	ketorolac tromethamine	0.45%	022427	1	2011-08-24
ACULAR LS	Ophthalmic Solution	ketorolac tromethamine	0.4%	021528	1	2005-01-28

US Patents and Regulatory Information for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bedford	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075230-002	Oct 25, 1999		DISCN	No	No
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes
Hetero Labs Ltd Iii	KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	216651-001	Aug 25, 2022	AB	RX	No	No
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y
Lupin Ltd	KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	210183-001	Jul 1, 2019	AT	RX	No	No

Expired US Patents for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009

International Patents for ketorolac tromethamine

Country	Patent Number	Title	Estimated Expiration
Australia	2004263149	Compositions for delivery of therapeutics into the eyes and methods for making and using same
World Intellectual Property Organization (WIPO)	2016077726
Canada	2796071	COMPOSITIONS DE KETOROLAC POUR LA CICATRISATION DE LESIONS CORNEENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING)
Colombia	6321226	COMPOSICIONES DE KETOROLAC TROMETAMINA PARA TRATAR O PREVENIR EL DOLOR OCULAR
Japan	5705552
European Patent Office	2446878	Compositions de kétorolac trométhamine pour traiter ou prévenir la douleur oculaire (Ketorolac tromethamine compositions for treating or preventing ocular pain)

Supplementary Protection Certificates for ketorolac tromethamine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Ketorolac tromethamine Market Analysis and Financial Projection Experimental

Ketorolac Tromethamine Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The ketorolac tromethamine market is poised for significant growth in the coming years. As of 2023, the market size was valued at approximately USD 100 billion, and it is projected to reach USD 140 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.8% from 2024 to 2031[1][3].

Driving Factors

Several key factors are driving the growth of the ketorolac tromethamine market:

Increasing Pain Management Needs

The rising prevalence of acute and chronic pain conditions is a major driver. As the global population experiences more pain-related issues, the demand for effective analgesics like ketorolac tromethamine increases[3].

Surgical Procedures

An increase in surgical interventions, particularly in orthopedic and dental surgeries, drives the need for postoperative pain management. Ketorolac tromethamine is highly effective in this context, contributing to its market growth[3].

Rising Geriatric Population

The growing elderly population, who often experience pain-related conditions, enhances the demand for effective pain relief medications. This demographic shift is a significant factor in the market's expansion[3].

Advancements in Formulations

Innovations in drug delivery systems, such as injectable forms, improve efficacy and patient compliance, further boosting the market[3].

Regulatory Approvals and Growing Awareness

New approvals and expanded indications for ketorolac tromethamine, along with increased awareness among healthcare providers and patients, lead to higher adoption rates[3].

Geographical Segmentation

The ketorolac tromethamine market is segmented geographically into several regions:

North America

North America dominates the market, driven by high prevalence rates of acute pain conditions, an advanced healthcare system, and robust research initiatives. The region accounted for around 40% of the global revenue in 2024 and is expected to grow at a CAGR of 9.7% from 2024 to 2031[4].

Europe

Europe follows closely, characterized by comprehensive pain management protocols and a growing emphasis on effective analgesics. The region held more than 30% of the global revenue in 2024 and is expected to grow at a CAGR of 10.0% from 2024 to 2031[4].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth due to increasing awareness about pain management, expanding healthcare access, and rising patient populations. Countries like India and China are particularly notable, with India expected to grow at a CAGR of 15.3% from 2024 to 2031[3][4].

Middle East and Africa, Latin America

These regions also contribute to the market, although to a lesser extent. The Middle East and Africa held around 2% of the global revenue in 2024, while Latin America held more than 5%, both with significant growth potential[4].

Financial Impact and Cost Benefits

Ketorolac tromethamine has significant financial benefits, particularly in the context of hospital resource utilization:

Reduced Hospital Costs

Studies have shown that the use of ketorolac tromethamine is associated with reduced lengths of stay, lower usage of narcotic drugs, and fewer adverse events. This results in lower overall hospital costs, especially for orthopedic surgery and cholecystectomy-related diagnoses[2].

Cost-Effective Pain Management

Ketorolac tromethamine offers cost advantages over opiate analgesics due to its narcotic-sparing effects. Linear regression modeling has demonstrated that ketorolac use is significantly related to reduced costs using inflation-adjusted dollars[2].

Challenges and Limitations

Despite the positive outlook, the market faces several challenges:

Regulatory Challenges

Strict regulations and approval processes from health authorities can hinder the introduction of new formulations or generics[3].

Adverse Effects

Potential side effects, such as gastrointestinal bleeding or kidney damage, may limit its use and acceptance among healthcare providers[3].

Competition from Alternatives

The presence of other nonsteroidal anti-inflammatory drugs (NSAIDs) and pain management options can affect market demand[3].

Market Saturation and Cost Constraints

As a well-established drug, the market may be saturated with existing products, making it harder for new entrants to gain a foothold. Economic factors, including pricing pressures from healthcare providers and insurers, may also impact profitability[3].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the ketorolac tromethamine market. While lockdown measures and supply chain interruptions affected production and demand, the drug's vital role in pain management protocols helped the market show some resilience. As healthcare systems adapted to pandemic conditions, the slow resumption of elective procedures and outpatient visits spurred market recovery[4].

Key Takeaways

• The ketorolac tromethamine market is expected to grow significantly, driven by increasing pain management needs, surgical procedures, and advancements in formulations.
• North America and Europe are the leading regions, with the Asia-Pacific region showing rapid growth.
• The drug offers significant cost benefits, including reduced hospital costs and narcotic-sparing effects.
• Despite challenges such as regulatory hurdles and adverse effects, the market is poised for continued growth.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of ketorolac tromethamine by 2031? A: The market is projected to reach USD 140 billion by 2031, growing at a CAGR of 3.8% from 2024 to 2031[1][3].

Q: What are the main drivers of the ketorolac tromethamine market? A: The main drivers include increasing pain management needs, rising surgical procedures, a growing geriatric population, and advancements in drug formulations[3].

Q: How does ketorolac tromethamine impact hospital costs? A: The use of ketorolac tromethamine is associated with reduced lengths of stay, lower usage of narcotic drugs, and fewer adverse events, resulting in lower overall hospital costs[2].

Q: Which regions dominate the ketorolac tromethamine market? A: North America and Europe are the leading regions, with the Asia-Pacific region showing rapid growth[3][4].

Q: What challenges does the ketorolac tromethamine market face? A: The market faces challenges such as regulatory hurdles, potential adverse effects, competition from alternatives, market saturation, and cost constraints[3].

Sources:

1. Market Research Intellect - Ketorolac Tromethamine Market Size and Projections
2. PubMed - Evaluation of the financial impact of ketorolac tromethamine therapy
3. Verified Market Research - Ketorolac Tromethamine Market Trends, Size & Forecast
4. Cognitive Market Research - Ketorolac Tromethamine Market Report 2024 (Global Edition)