TORADOL Drug Patent Profile

Which patents cover Toradol, and when can generic versions of Toradol launch?

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-two 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

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

International Patents for TORADOL

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	8100357	1,2-DIHYDRO-3H-PYROLO[1,2-A]PYRROLE-1-CARBOXYLIC ACID DERIVATIVES AND PROCESS FOR THE PRODUCTION THEREOF
Denmark	479880
Japan	S539788	55ALOYLL1*22DIHYDROO3HH PYRORO *1*22A* PYROLL11 CARBOXYLIC ACID DERIVATIVE
Denmark	151336

Supplementary Protection Certificates for TORADOL

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	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	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: February 3, 2026

What Is the Investment Outlook for Toradol (Ketorolac)?

Toradol (generic: ketorolac) remains a widely used NSAID for short-term management of moderate to severe pain. Its market presence is sustained by its efficacy, but its future growth is subject to regulatory, safety concerns, and competitive dynamics that influence its investment profile.

What Are the Market Dynamics and Revenue Trends?

Market Adoption and Usage

• Developed as an alternative to opioid analgesics, especially post-2010 amid opioid epidemic concerns.
• Prescribed primarily in hospital settings for acute pain management.
• Annual global sales estimated to be around $150 million to $300 million[1].

Revenue Trends

• Fluctuations occur due to safety warnings and regulatory restrictions.
• US sales decreased by approximately 15% between 2019 and 2022, partly attributed to concerns over adverse effects.
• Growth in certain markets such as Europe remains stable but stagnant due to substitution by newer NSAIDs and non-NSAID analgesics.

Regulatory Environment

• FDA approved Toradol in 1989; safety warnings about gastrointestinal bleeding and renal impairment appeared in the 1990s.
• Johnson & Johnson (marketed as Toradol) withdrew the branded product from some markets in 2021, shifting focus to generics.
• US regulations restrict use to 5 days or less due to adverse effects[2].

How Do Safety and Adverse Effects Impact Investment?

Safety Considerations

• Serious adverse events include gastrointestinal bleeding, renal failure, and cardiovascular risks.
• These safety concerns have led to black box warnings in the US.
• Stricter prescribing guidelines reduce volume, affecting sales.

Impact on Market Viability

• Industry trends favor alternative pain management medications with better safety profiles.
• Ongoing safety concerns may impair long-term revenue potential.
• New formulations with reduced adverse effects are in development but are not yet mainstream.

What Are the Competitive Factors?

Competitor Landscape

• Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, and diclofenac dominate over-the-counter and prescription markets.
• Opioids, despite regulatory restrictions, remain a significant alternative for acute pain management.
• New analgesic drugs and non-opioid pain therapies continue to emerge.

Patent and Market Exclusivity

• Toradol’s original patents have long expired; no significant patent exclusivity exists.
• Generics hold a dominant position, leading to low margins for producers.

Pharmacological and Formulation Innovation

• Limited innovation in long-acting or targeted NSAID formulations.
• With safety concerns paramount, investment in new delivery systems or safer derivatives faces regulatory hurdles.

What Is the Fundamental Investment Case?

Prospects

• Existing demand in hospital and emergency settings.
• Potential expansion into new formulations with better safety profiles.

Risks

• Declining sales driven by safety warnings and regulatory limits.
• Competitive pressure from safer or more effective pain management drugs.
• Litigation risk associated with adverse event claims.

Financial Health of Manufacturers

• Firms primarily involved in manufacturing are facing margin compression.
• Large pharmaceutical companies with diversified opioid and NSAID portfolios are less exposed to Toradol-specific risks.

What Key Factors Should Investors Watch?

• Development of safer NSAID formulations and alternative pain therapies.
• Regulatory changes that may either restrict or expand the use of ketorolac.
• Changes in prescribing guidelines due to safety concerns.
• Entry of new analgesic drugs with fewer adverse effects.
• Patent status and market exclusivity timelines.

Key Takeaways

• Toradol remains a short-term pain management remedy with significant safety concerns limiting its growth.
• Market revenue is in decline, influenced by regulation, safety warnings, and competition.
• Innovation in safer NSAID formulations could provide future growth opportunities, but regulatory hurdles present challenges.
• The generic landscape diminishes potential for high-margin growth.
• Long-term investment relies on regulatory shifts and developments in pain management alternatives.

Frequently Asked Questions

Q1: Is Toradol a good investment for the long term?
A1: Limited due to safety concerns, declining revenues, and generic competition.

Q2: Are there new formulations of ketorolac under development?
A2: No widespread, clinically approved safer formulations currently available; research continues.

Q3: How does regulatory risk affect Toradol’s market potential?
A3: Stringent prescribing restrictions and safety warnings cap usage; regulatory changes could either hinder or restore market access.

Q4: Can patent protection influence investment returns?
A4: Not significantly, as patents expired long ago; generic competition dominates.

Q5: What alternative pain management drugs could replace Toradol?
A5: Non-opioid medications like acetaminophen and newer NSAIDs with better safety profiles; opioids for severe pain in controlled settings.

References

1. IBISWorld Industry Report, 2022.
2. FDA Drug Safety Communications, 2021.