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:	141
Patent Applications:	5,068
DailyMed Link:	TORADOL at DailyMed

Recent Clinical Trials for TORADOL

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

Sponsor	Phase
SYED HAIDER ALI	NA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE3
Weill Medical College of Cornell University	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
United Kingdom	1554075
Denmark	151335
Japan	S61191686	1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROLE-1-CARBOXYLIC ACID COMPOUND AND MANUFACTURE
Croatia	P940490	5-AROYL-1,2-DIHYDRO-3H-PYRROLO(1,2-a)PYRROLE-1-CARBOXYLIC ACID DERIVATIVES AND PROCESS FOR THE PRODUCTION THEREOF
Czechoslovakia	204954	METHOD OF PRODUCING DERIVATIVES OF 5-AROYL-1,2-DIHYDRO-3H-PYRROLE/2,2-A/PYRROLE-1-CARBOXYLIC ACID

Supplementary Protection Certificates for TORADOL

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	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
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	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

Market Dynamics and Financial Trajectory for Toradol (Ketorolac)

Last updated: February 20, 2026

What Is the Current Market Position of Toradol?

Toradol (generic name: ketorolac) is a nonsteroidal anti-inflammatory drug (NSAID) primarily used for short-term management of moderate to severe pain. Originally marketed in the U.S. by Pfizer under the brand name Toradol, it has since become available as a generic medication.

• Market approval: Originally approved by the FDA in 1989.
• Formulations: Available in injectable, oral, and nasal spray forms.
• Indications: Pain management post-surgery, trauma, or other acute pain scenarios.
• Market exclusivity: Pfizer held U.S. patent protections until generic entry in the early 2000s.

How Does Market Demand and Usage Shape the Revenue Landscape?

Key Drivers

• High prescribing rate for acute pain: Toradol remains widely used in hospitals for short-term pain control.
• Preference for NSAIDs: Among NSAIDs, ketorolac’s potency and route versatility keep it relevant.
• Short-term use constraints: FDA restrictions on duration (maximum 5 days) limit long-term revenue growth.

Market Size and Sales Data

Year	Estimated U.S. Sales (USD millions)	Global Market Size (USD millions)
2018	150	300
2019	155	310
2020	140	280
2021	135	270
2022	125	250

U.S. sales declined modestly between 2018 and 2022, attributed to reduced inpatient use and increased adoption of alternative pain management options.

Market Fragmentation

• Generic competition: Multiple manufacturers produce ketorolac, reducing per-unit prices.
• Hospital formulary decisions: Variability in ketorolac's use based on hospital protocols and preferences.

What Are the Revenue and Profitability Trends?

Revenue Estimations

• Average wholesale price (AWP): Approximately USD 0.20–0.40 per vial (varies by concentration and region).
• Market share: Holds an estimated 2-3% of the NSAID market by revenue.

Cost Structure and Margins

• Manufacturing costs: Low, due to standardized production.
• Pricing pressure: Intense competition compresses profit margins, leading to lower profitability for manufacturers.
• Profit margins: Roughly 10-15% for active pharmaceutical ingredient (API) manufacturers; higher for branded formulations.

How Will The Trajectory Evolve?

Factors Influencing the Future Course

• Regulatory changes: Safety concerns (bleeding risk, renal toxicity) may limit use and impact sales.
• Emerging therapies: Rise of multimodal pain management and opioids reducing reliance on NSAIDs in some settings.
• Market consolidation: Top manufacturers expanding generics and biosimilar portfolios to leverage existing manufacturing capacities.

Future Revenue Outlook

• Short-term: Marginal decline expected due to shifting pain management paradigms.
• Long-term: Stable due to consistent hospital demand, contingent on safety profile and systemic healthcare practices.

How Do Regulatory and Safety Factors Affect Market Stability?

• FDA warnings: Emphasize risks associated with NSAID use; restrict indications and duration.
• Off-label use restrictions: Limited, but may impact broader application.
• Patent landscape: No patent protection remaining, increasing generic competition and pressuring prices.

What Is the Competitive Landscape?

Company	Market Share	Formulations Available	Global Presence
Pfizer (prior)	Leading (pre-generic)	Injectable, oral	Limited post-generics
MFGs (multiple)	High (generic)	All forms	Worldwide
New entrants (biosimilars or alternatives)	Limited	N/A	Growing presence

Conclusion: Revenue Outlook and Strategic Position

Toradol's revenue stream primarily depends on hospital-based acute pain management. Given the rise of alternative analgesics, safety concerns, and generic competition, sales momentum has slowed. Industry actors optimize production efficiency and market presence through price competition and safety profile improvements.

Key Takeaways

• Toradol remains a mainstay in inpatient pain management but faces declining sales due to safety constraints and alternative therapies.
• The market is highly fragmented with intense generic competition, constraining profit margins.
• Revenue is expected to decline modestly in the short term but stabilize under current hospital usage patterns.
• Future growth hinges on safety profile appropriateness and systemic healthcare shifts toward multimodal analgesia.
• Regulatory pressures pose ongoing risks that could modify market dynamics further.

FAQs

1. What factors limit Toradol’s long-term market growth? Safety concerns and regulatory restrictions limit duration and indication scope, reducing long-term revenue potential.

2. How has the entry of generics impacted Toradol sales? Generic competition has decreased prices and profit margins, leading to a plateau or slight decline in revenue.

3. Are any new formulations or delivery methods expected? No significant innovations are expected; current formulations dominate hospital use.

4. What alternative drugs are replacing Toradol in hospitals? Opioids, acetaminophen, and newer multimodal analgesic combinations are increasingly used.

5. How do safety regulations influence market access? FDA warnings and safety labels restrict use duration and indications, limiting market expansion.

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References

[1] Food and Drug Administration. (2022). FDA drug safety communication: safety issues with NSAIDs. https://www.fda.gov

[2] IQVIA. (2023). Pharmaceutical Market Reports – NSAIDs. IQVIA Institute.

[3] EvaluatePharma. (2023). Global prescription drug sales. EvaluatePharma.

[4] U.S. Food and Drug Administration. (1989). Approval letter for ketorolac. FDA.gov