TORADOL Drug Patent Profile

When do Toradol patents expire, and what generic alternatives are available?

Toradol is a drug marketed by Roche Palo and is included in two NDAs.

The generic ingredient in TORADOL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Toradol

A generic version of TORADOL was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for TORADOL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	140
Patent Applications:	5,068
DailyMed Link:	TORADOL at DailyMed

Recent Clinical Trials for TORADOL

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

Sponsor	Phase
Weill Medical College of Cornell University	PHASE3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE3
Islamabad Medical and Dental College	PHASE3

See all TORADOL clinical trials

US Patents and Regulatory Information for TORADOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche Palo	TORADOL	ketorolac tromethamine	INJECTABLE;INJECTION	019698-001	Nov 30, 1989		DISCN	Yes	No
Roche Palo	TORADOL	ketorolac tromethamine	INJECTABLE;INJECTION	019698-002	Nov 30, 1989		DISCN	Yes	No
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991		DISCN	Yes	No

Expired US Patents for TORADOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991

International Patents for TORADOL

See the table below for patents covering TORADOL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2760330
Yugoslavia	40816
Denmark	480080
Slovenia	7711721	PROCESS FOR OBTAINING 5-AROYL-1,2 DEHYDRO-3H-PYRROLO (1,2-A)PYRROL-1-CARBOXYLIC DERIVATIVES
Hungary	174224	SPOSOB POLUCHENIJA PROIZVODNYKH 5-BENZOIL-1,2-DIGIDRO-3H-PIRROLO/1,2-A/PIRROLIL-1-KARBONOVOJJ KISLOTY (PROCESS FOR PREPARING 5-BENZOYL-1,2-DIHYDRO-3H-PYRROLO/1,2-A/PYRROLE-1-CARBOXYLIC ACID DERIVATIVES)

Supplementary Protection Certificates for TORADOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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	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

Last updated: July 31, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: TORADOL

Introduction

Toradol (generic name: ketorolac) remains a prominent non-steroidal anti-inflammatory drug (NSAID) widely utilized for short-term pain management. Since its introduction, Toradol’s market dynamics have been shaped by regulatory, clinical, and economic factors influencing its sales trajectory. This article provides a comprehensive analysis of Toradol’s current market landscape, competitive positioning, regulatory environment, and financial prospects, offering valuable insights for pharmaceutical stakeholders.

Overview of Toradol (Ketorolac)

Developed by Pfizer in 1989, Toradol gained rapid acceptance as an effective analgesic for moderate to severe pain, particularly in postoperative settings. Its unique profile of potent analgesic effects without being a controlled substance initially contributed to its widespread use [1]. Later formulations included intravenous (IV), intramuscular (IM), and oral forms, broadening its clinical application scope.

Market Size & Segment Analysis

The global NSAID market, which includes drugs like ibuprofen, naproxen, diclofenac, and ketorolac, was valued at approximately USD 11 billion in 2022, with expected compounded annual growth rate (CAGR) of around 4.2% through 2030 [2]. Within this, ketorolac holds a niche segment primarily focused on hospital and surgical pain management due to its high potency and short duration of action.

In the US, analgesic drugs constitute a significant portion of prescription NSAIDs, with hospital settings accounting for roughly 35% of Toradol prescriptions. The demand is driven by its efficacy in managing acute pain episodes post-surgery, trauma, or dental procedures, making it an indispensable tool in acute care settings.

Regulatory and Clinical Factors

Although Toradol remains FDA-approved, it faces safety advisories over the years. The Drug Safety Communications issued in the early 2000s highlighted risks of gastrointestinal bleeding, renal impairment, and gastrointestinal perforation, especially with prolonged use [3]. Consequently, regulatory agencies have mandated strict labeling requirements emphasizing short-term use, typically limited to 5 days.

The clinical landscape has evolved, with alternative pain management approaches, including opioids and novel NSAIDs, impacting Toradol’s utilization. The opioid crisis prompted increased scrutiny on analgesics, leading to more cautious prescribing practices. Moreover, the advent of non-opioid multimodal analgesia, incorporating acetaminophen, gabapentinoids, and regional anesthesia techniques, has partially displaced Toradol use in certain settings.

Competitive Environment

Toradol’s primary competitors include other injectable NSAIDs (e.g., diclofenac, meloxicam) and opioid analgesics. The safety profile limitations have also accelerated the development and approval of alternative analgesics with improved safety margins. Additionally, non-pharmacologic modalities, such as nerve blocks and physical therapy, further challenge traditional NSAID usage in pain management.

Despite these challenges, Toradol maintains a competitive advantage in acute surgical and inpatient care where rapid pain relief is critical, and its short-term use aligns with safety guidelines. Its cost-effectiveness and broad availability sustain its demand in hospital formularies.

Emerging Trends Impacting Toradol’s Market

1. Enhanced Safety Profiles:
Innovations aiming to reduce NSAID-associated adverse effects have gained interest. Encapsulation technologies and targeted delivery could enhance Toradol's safety, potentially revitalizing its usage scope.

2. Digital and Precision Medicine:
Personalized pain management plans are increasingly prevalent. Pharmacogenomics could identify patient subsets with lower risk of adverse effects, influencing Toradol’s prescribing patterns favorably.

3. Mergers and Portfolio Optimization:
Major pharmaceutical companies, including Pfizer and Novartis, have restructured portfolios, sometimes divesting NSAID assets due to limited growth potential, thereby impacting market dynamics.

4. Regulatory Environment:
Future policy updates, especially emphasizing opioid alternatives and controlled substance regulations, could either bolster or constrain Toradol’s market share depending on safety innovations and formulary decisions.

Financial Trajectory & Forecasts

The financial trajectory of Toradol hinges on several factors, including drug sales volume, pricing strategies, competitive pressures, and regulatory constraints.

Current Revenue Landscape:
Pfizer’s branded postoperative pain management portfolio, which includes Toradol, is estimated to generate US$300-400 million annually, representing a significant but mature segment. The decline in new prescriptions over recent years has been marginally offset by price adjustments and increased institutional demand.

Market Outlook (2023–2030):
Given its niche role, Toradol’s sales are projected to decline at a modest CAGR of approximately 1-2% over the next decade, primarily due to market saturation, safety concerns, and competition from alternative therapies.

However, strategic initiatives such as reformulation with improved safety profiles, partnerships with healthcare providers, and inclusion in multimodal pain management protocols could stabilize or slightly improve its financial performance.

Influencing Factors:

• Regulatory pressures: Accelerated safety guidelines may limit use, constraining growth.
• Competitive innovations: Development of safer NSAID formulations may erode Toradol’s market share.
• Hospital formulary dynamics: The shift towards multimodal pain strategies could reduce reliance on single agents such as Toradol.
• Pricing strategies: Price resilience is crucial, especially in institutional settings where volume is key.

Conclusion

Toradol remains a critical agent in acute pain management within hospital and surgical settings. Its market is characterized by stability but limited growth prospects due to safety concerns, competition, and changing clinical practices. Nonetheless, strategic innovation and regulatory navigation could sustain its financial trajectory amidst an evolving analgesic landscape.

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Key Takeaways

• Market remains niche but essential in hospital-based acute pain management.
• Regulatory and safety concerns continue to influence prescribing patterns and usage limitations.
• Market growth is modest, with projections indicating slight decline due to competitive and safety factors.
• Innovation in delivery and safety profiles could create opportunities to extend Toradol’s market lifespan.
• Stakeholders should monitor shifts in pain management protocols and regulatory policies to adapt their strategies effectively.

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FAQs

1. How has regulatory scrutiny affected Toradol’s market?
Regulatory agencies have imposed strict label warnings on gastrointestinal and renal risks, limiting long-term use and influencing prescriber caution, thereby constraining market growth.

2. What are the main competitors to Toradol in acute pain management?
Other injectable NSAIDs like diclofenac and non-NSAID multimodal therapies, as well as opioids, serve as primary competitors.

3. Can Toradol’s safety profile be improved to regain market share?
Future innovations targeting delivery systems or formulations could mitigate adverse effects, potentially enhancing its market appeal.

4. What is the expected trend for Toradol’s sales over the next decade?
Sales are expected to decline modestly, around 1-2% CAGR, barring significant safety or formulation advancements.

5. How does the opioid crisis influence Toradol’s use?
The opioid crisis has prompted clinicians to prefer NSAIDs like Toradol for short-term pain, but safety concerns and new analgesic options also limit its overall utilization.

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References

[1] Pfizer. (2022). Toradol (ketorolac) Prescribing Information.
[2] Grand View Research. (2022). NSAID Market Size, Share & Trends.
[3] FDA. (2003). Safety Communication on NSAIDs and Gastrointestinal Risks.