Ketorolac tromethamine - Generic Drug Details

What are the generic sources for ketorolac tromethamine and what is the scope of patent protection?

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 seven 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-five suppliers are listed for this compound.

Summary for ketorolac tromethamine

International Patents:	68
US Patents:	7
Tradenames:	9
Applicants:	41
NDAs:	64
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	65
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	108
Patent Applications:	6,010
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
Canadian Institutes of Health Research (CIHR)	Phase 3
University of Calgary	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
Steriscience Speclts	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	078299-002	Jul 16, 2007		DISCN	No	No
Wockhardt Bio Ag	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	077943-001	Mar 27, 2007		DISCN	No	No
Caplin	KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	218204-001	Mar 26, 2024	AT	RX	No	No
Mylan	KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	074761-001	May 16, 1997	AB	RX	No	No
Fresenius Kabi Usa	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075784-002	Jan 11, 2002	AP	RX	No	No

Expired US Patents for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997	4,454,151*PED
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,207,215*PED
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	5,110,493*PED
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	4,089,969
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	9,216,127

International Patents for ketorolac tromethamine

Country	Patent Number	Title	Estimated Expiration
New Zealand	588367	KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN
Slovenia	2555770
Spain	2332049
Denmark	2446878
Denmark	2257275

Supplementary Protection Certificates for ketorolac tromethamine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
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	92923	Luxembourg		PRODUCT NAME: UNE 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; FIRST REGISTRATION: 20150730

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)