KETOROLAC TROMETHAMINE - Generic Drug Details

What are the generic drug 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, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Onesource Specialty, Sagent Pharms Inc, Sandoz, Sun Pharm, 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-three 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:	63
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	115
Patent Applications:	8,070
Drug Prices:	Drug price trends 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
SYED HAIDER ALI	NA
Al-Azhar University	EARLY_PHASE1
University of Maryland St. Joseph Medical Center	PHASE4

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
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,486,406*PED				Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	7,842,714		Y	Y
Apotex Inc	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075626-001	Jul 24, 2001		DISCN	No	No
Chartwell Rx	KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	078434-001	Nov 5, 2009		DISCN	No	No
Onesource Specialty	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	078299-001	Jul 16, 2007		DISCN	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	9,216,167
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	8,946,281
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997	4,454,151*PED
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010	6,333,044

International Patents for KETOROLAC TROMETHAMINE

Country	Patent Number	Title	Estimated Expiration
Canada	2468664	COMPOSITIONS A BASE DE KEROTOLAC TROMETHAMINE POUR TRAITER OU PREVENIR LA DOULEUR OCULAIRE (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN)
Australia	2011237646
South Korea	20100130989	KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN
European Patent Office	1654002	COMPOSITIONS D'ADMINISTRATION D'AGENTS THERAPEUTIQUES DANS LES YEUX ET LEURS METHODES D'ELABORATION ET D'UTILISATION (COMPOSITIONS FOR DELIVERY OF THERAPEUTICS INTO THE EYES AND METHODS FOR MAKING AND USING THE SAME)
Spain	2382509

Supplementary Protection Certificates for KETOROLAC TROMETHAMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
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
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	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

Ketorolac Tromethamine: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) primarily used for short-term management of moderate to moderately severe pain. Its market trajectory is characterized by established use, generic competition, and evolving delivery methods.

What is the Current Market Size and Growth Rate for Ketorolac Tromethamine?

The global ketorolac tromethamine market is a mature segment within the pain management therapeutic area. Precise, up-to-the-minute market size figures are dynamic and vary by market research firm. However, industry reports indicate a stable to slightly declining market in terms of revenue for the traditional injectable and oral formulations due to increased generic penetration and the availability of newer pain management alternatives.

• Estimated Market Value: While specific recent figures are proprietary, the global NSAID market, which includes ketorolac, was valued in the tens of billions of dollars annually. Ketorolac tromethamine represents a fraction of this, with its market size primarily driven by hospital and acute care settings where its potent analgesic properties are leveraged for short durations.
• Growth Rate: The Compound Annual Growth Rate (CAGR) for ketorolac tromethamine, particularly for its established formulations, is projected to be low, potentially in the negative single digits, or close to flat. This is attributed to:
  • Generic Competition: The drug has been off-patent for a considerable period, leading to widespread generic availability and intense price competition.
  • Therapeutic Alternatives: Advancements in pain management have introduced a range of alternative analgesics, including opioids (with careful monitoring), other NSAIDs with different side effect profiles, and non-pharmacological interventions.
  • Safety Concerns: Like other NSAIDs, ketorolac tromethamine carries risks of gastrointestinal bleeding, renal impairment, and cardiovascular events, which can limit its long-term use and favor alternatives in certain patient populations.
• Emerging Niches: Growth may be observed in specific, niche applications or novel delivery systems that aim to improve efficacy or safety. For instance, topical formulations or sustained-release versions, if developed and approved, could carve out new market segments.

Which are the Key Therapeutic Areas and Applications for Ketorolac Tromethamine?

Ketorolac tromethamine's primary utility lies in its potent analgesic effect, making it suitable for conditions requiring rapid and effective pain relief over a limited period.

• Postoperative Pain: This is the most significant application. Ketorolac is frequently used to manage pain following surgical procedures, including orthopedic surgery, abdominal surgery, and dental extractions. Its efficacy is comparable to that of some opioids for moderate pain, with a generally lower risk of respiratory depression.
• Acute Musculoskeletal Pain: For short-term relief of severe musculoskeletal injuries such as sprains, strains, and fractures, ketorolac is an option.
• Renal Colic: Its anti-inflammatory and analgesic properties can help alleviate the severe pain associated with kidney stones.
• Other Acute Pain Conditions: It may be used for other acute pain scenarios where oral or other NSAIDs are insufficient and opioid use is to be minimized.

Delivery Methods and Their Market Impact:

The formulation and route of administration significantly influence market penetration and specific application areas:

• Injectable (Intramuscular/Intravenous): This is the most common and potent form, favored in hospital settings for rapid pain control post-surgery or in acute pain emergencies. The market for injectable ketorolac is mature and faces competition from other parenteral analgesics.
• Oral (Tablets/Capsules): Used for follow-up pain management after initial injectable therapy or for less severe acute pain. The oral market is highly competitive due to generics.
• Ophthalmic (Eye Drops): Ketorolac ophthalmic solutions are used post-operatively to reduce inflammation and pain following cataract surgery and other ocular procedures. This represents a distinct, albeit smaller, market segment.
• Nasal Spray: Ketorolac nasal spray represents a newer delivery method designed for rapid absorption and to bypass first-pass metabolism, potentially offering a faster onset of action than oral forms for acute pain. This formulation aims to capture a segment of the outpatient acute pain market.

What is the Competitive Landscape for Ketorolac Tromethamine?

The competitive landscape for ketorolac tromethamine is characterized by a high degree of genericization and competition from other NSAIDs and alternative pain management strategies.

Direct Competitors (Other NSAIDs):

• Ibuprofen: Widely available, over-the-counter (OTC) and prescription strengths. Lower potency but broader use due to safety profile for longer-term use.
• Naproxen: Available OTC and prescription. Longer half-life than ibuprofen, allowing for less frequent dosing.
• Diclofenac: Available in various formulations, including topical. Potent NSAID.
• Celecoxib: A COX-2 selective inhibitor, often favored for its potentially lower gastrointestinal risk profile.

Indirect Competitors (Alternative Pain Management):

• Opioid Analgesics: Morphine, hydromorphone, oxycodone, hydrocodone. Reserved for severe pain due to addiction potential and side effects. Their use is increasingly scrutinized and restricted.
• Acetaminophen (Paracetamol): A non-NSAID analgesic and antipyretic, often used in combination with NSAIDs or opioids. Lower efficacy for inflammatory pain but generally a favorable safety profile.
• Non-Pharmacological Therapies: Physical therapy, acupuncture, nerve blocks, psychological interventions.

Key Competitive Factors:

• Price: Due to genericization, price is a major differentiator, particularly for high-volume institutional purchasers.
• Efficacy and Onset of Action: Ketorolac's rapid and potent analgesia remains its primary advantage in acute settings.
• Safety Profile and Side Effects: The risk of GI bleeding, renal toxicity, and cardiovascular events is a significant consideration and drives preference for alternatives in certain patient groups or for longer durations of treatment.
• Route of Administration: Availability in various forms (injection, oral, ophthalmic, nasal) caters to different clinical needs and patient populations.
• Brand vs. Generic: While originator brands may hold some market share, the vast majority of sales are through generic manufacturers.

What are the Key Patent Expirations and Market Exclusivity Considerations?

Ketorolac tromethamine's core patent protection has long since expired. This means that the drug has been available as a generic product for many years, significantly impacting its market dynamics.

• Original Patent Expiration: The original patents protecting ketorolac tromethamine, particularly for its initial formulations, expired decades ago. This paved the way for generic manufacturers to enter the market.
• Generic Market Dominance: The market is dominated by generic versions of ketorolac tromethamine. Multiple pharmaceutical companies produce and market generic formulations, leading to intense price competition.
• Limited Opportunities for New Patents: The primary patents are expired, making it difficult for new entrants to establish market exclusivity based on novel composition-of-matter patents for the basic drug.
• Potential for Formulation Patents: Innovation in ketorolac tromethamine has primarily focused on new delivery systems or formulations designed to improve patient compliance, reduce side effects, or enhance efficacy.
  • Nasal Spray Formulation: Patents related to the specific formulation and delivery device for ketorolac nasal spray may have provided a period of market exclusivity for the innovator product. However, generic versions of nasal sprays also exist or are likely to emerge.
  • Ophthalmic Formulations: Patents may have covered specific ophthalmic formulations.
  • Combination Products: Patents could exist for novel combination therapies involving ketorolac, though this is less common for short-acting analgesics.
  • Manufacturing Processes: Patents may cover novel or improved manufacturing processes, offering a competitive advantage rather than market exclusivity.
• Impact on Pricing and Profitability: The absence of patent protection for the core molecule has resulted in significantly lower prices compared to patented drugs. This limits the profit margins for generic manufacturers and makes the market highly sensitive to volume and cost efficiencies.
• Regulatory Exclusivity: In some instances, new formulations or indications might qualify for periods of regulatory exclusivity (e.g., New Chemical Entity exclusivity if a significant modification were made, or exclusivities for pediatric studies), but this is rare for older drugs like ketorolac.

What are the Key Regulatory and Safety Considerations Affecting the Market?

Regulatory scrutiny and safety considerations play a crucial role in shaping the market for ketorolac tromethamine, influencing prescribing patterns and market access.

• Black Box Warnings: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), have issued black box warnings for NSAIDs, including ketorolac tromethamine, highlighting serious risks:
  • Cardiovascular Thrombotic Events: Increased risk of myocardial infarction and stroke.
  • Gastrointestinal Bleeding, Ulceration, and Perforation: Potentially fatal events can occur at any time during treatment, with or without warning symptoms.
  • Renal Effects: Can cause dose-dependent reduction in prostaglandin formation, leading to renal disease.
• Short-Term Use Indication: Due to these risks, ketorolac tromethamine is approved and recommended for short-term use only (typically not exceeding five days). This restriction limits its use as a chronic pain management agent.
• Prescribing Guidelines: Healthcare providers must adhere to strict prescribing guidelines, carefully assessing patient risk factors (e.g., history of GI bleeding, renal impairment, cardiovascular disease) before prescribing ketorolac.
• Post-Marketing Surveillance: Ongoing pharmacovigilance and post-marketing surveillance by regulatory agencies monitor for adverse events, which can lead to updated labeling or even market withdrawals if severe safety issues emerge.
• Dosing Restrictions: Regulatory approvals specify maximum daily doses and treatment durations, which are critical for safe and effective use.
• Ophthalmic Use Restrictions: While used for pain and inflammation post-ocular surgery, its use is governed by specific ophthalmic guidelines and warnings related to potential corneal effects with prolonged use.
• Generics vs. Branded: Regulatory agencies ensure that generic versions are bioequivalent to the branded product. However, any post-patent safety alerts or labeling changes from the innovator product often apply to all marketed versions.
• Market Access and Reimbursement: Reimbursement policies by payers (insurance companies, government health programs) are influenced by safety profiles and cost-effectiveness. Drugs with significant safety concerns or higher costs relative to alternatives may face restricted access or require prior authorization.

What is the Future Outlook and Potential for Innovation?

The future of ketorolac tromethamine is largely tied to its established role in acute pain management, with limited prospects for significant market expansion but potential for niche growth through formulation innovation.

• Continued Use in Acute Care: Ketorolac tromethamine will likely remain a staple in hospital formularies and emergency departments for short-term management of moderate to severe acute pain, especially post-operatively. Its cost-effectiveness and potency are key drivers.
• Pressure from Alternatives: The increasing focus on opioid-sparing strategies may offer some advantage, but competition from other NSAIDs with potentially better safety profiles for certain patient groups, and advancements in non-opioid analgesics, will continue to exert pressure.
• Formulation and Delivery Innovation:
  • Enhanced Nasal Delivery: Further refinement of nasal spray technology to improve absorption, reduce nasal irritation, and ensure consistent dosing could expand its use in outpatient acute pain settings. This could target conditions like acute migraine or other severe episodic pain.
  • Topical Formulations: Development of effective topical ketorolac formulations for localized musculoskeletal pain could offer a safer alternative to oral or injectable forms, reducing systemic exposure and associated risks. However, achieving adequate skin penetration and therapeutic concentrations is a significant formulation challenge.
  • Sustained-Release or Targeted Delivery: While the drug's short-term use profile makes sustained-release formulations less intuitive, novel delivery systems that offer controlled release over a few days for specific post-operative scenarios might be explored, provided they can mitigate safety concerns.
• Repurposing or Combination Therapies: Although unlikely for such a well-established drug, research into novel synergistic effects with other analgesics or pain modulators cannot be entirely ruled out, but this would necessitate significant R&D investment and new patent applications.
• Geographic Market Expansion: In emerging markets, where access to newer or more expensive pain management options may be limited, generic ketorolac tromethamine could see continued demand.
• Focus on Risk Mitigation: Future development will likely concentrate on formulations or co-therapies that mitigate known NSAID risks, such as gastrointestinal or cardiovascular events.

Market Challenges:

• Genericization and Price Erosion: This remains the primary market characteristic, limiting revenue growth potential.
• Safety Concerns: The persistent black box warnings and associated prescribing restrictions will continue to limit broad application.
• Competition: The landscape of pain management is highly dynamic, with ongoing development of novel analgesics and non-pharmacological approaches.

Key Takeaways

• The ketorolac tromethamine market is mature, characterized by extensive generic competition and stable to declining revenue for traditional formulations.
• Primary applications are in acute pain management, notably postoperative pain, where its potency and rapid onset are valued.
• The drug carries significant safety warnings (cardiovascular, gastrointestinal, renal), limiting its use to short-term indications and strict adherence to prescribing guidelines.
• Innovation is primarily focused on novel delivery methods (e.g., nasal spray, ophthalmic) rather than new chemical entities, offering potential for niche market growth.
• Original patent protection has long expired, leaving market exclusivity dependent on patents for new formulations or delivery systems, which are limited in scope and duration.

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Frequently Asked Questions

What are the primary risks associated with ketorolac tromethamine use?

The primary risks include cardiovascular thrombotic events (myocardial infarction and stroke), gastrointestinal bleeding, ulceration, and perforation, and renal impairment.

For how long is ketorolac tromethamine typically prescribed?

Ketorolac tromethamine is indicated for short-term use only, generally not exceeding five days, due to its significant safety risks.

Is ketorolac tromethamine an opioid?

No, ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID). It is not an opioid analgesic.

What are the advantages of the nasal spray formulation of ketorolac tromethamine compared to oral or injectable forms?

The nasal spray formulation aims for rapid absorption and bypass of first-pass metabolism, potentially leading to a faster onset of action compared to oral forms for acute pain.

What impact does genericization have on the ketorolac tromethamine market?

Genericization leads to intense price competition, significantly lower prices for the drug, and limits the profit margins for manufacturers. The market is dominated by generic products.