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:	97
Clinical Trials:	137
Patent Applications:	4,765
DailyMed Link:	TORADOL at DailyMed

Recent Clinical Trials for TORADOL

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Damascus University	N/A
Arkansas Children's Hospital Research Institute	Phase 4

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	4,089,969

International Patents for TORADOL

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	641458	Process for preparing 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acid esters
Ireland	45253	1,2-DIHYDRO-3H-PYRROLO (1,2-A)PYRROLE-1-CARBOXYLIC ACID DERIVATIES AND PROCESS FOR THE PRODUCTION THEREOF
Poland	109390
Australia	2697577

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	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
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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728

TORADOL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Ketorolac Tromethamine (TORADOL)

Introduction to Ketorolac Tromethamine

Ketorolac Tromethamine, commonly known by the brand name TORADOL, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for managing moderate to severe pain. Here, we delve into the market dynamics and financial trajectory of this essential medication.

Market Size and Forecast

The Ketorolac Tromethamine market has been valued at approximately USD 98.67 billion in 2023 and is projected to reach USD 139.01 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.8% during the forecast period from 2024 to 2031[1][4].

Key Drivers of Market Growth

Increasing Pain Management Needs

The rise in the prevalence of acute and chronic pain conditions is a significant driver of the market. As more people seek effective pain relief, the demand for analgesics like Ketorolac Tromethamine increases[1][4].

Surgical Procedures

An increase in surgical interventions, particularly in orthopedic and dental surgeries, drives the need for postoperative pain management. Ketorolac Tromethamine is often used in these scenarios due to its efficacy in reducing pain and minimizing the use of narcotics[1][4].

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 expected to continue driving market growth[1].

Advancements in Formulations

Innovations in drug delivery systems, such as injectable forms, improve efficacy and patient compliance. These advancements are crucial in maintaining the market's momentum[1].

Regulatory Approvals

New approvals and expanded indications for Ketorolac Tromethamine can create significant opportunities for market growth. Regulatory support is vital for the introduction of new formulations and generics[1].

Growing Awareness

Increased awareness about pain management options among healthcare providers and patients can lead to higher adoption rates. Educational initiatives and marketing efforts play a key role in this aspect[1].

Geographical Market Segmentation

The Ketorolac Tromethamine market is segmented geographically into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America.

North America

North America is a significant market driven by high prevalence rates of acute pain conditions, an advanced healthcare system, and robust research initiatives. The presence of key pharmaceutical companies and established distribution networks further supports this region[1].

Europe

Europe follows closely, characterized by comprehensive pain management protocols and a growing emphasis on effective analgesics. Regulatory support and healthcare policies advocating for quality pain relief are key factors[1].

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[1].

Middle East and Africa

In the Middle East and Africa, market dynamics are influenced by ongoing advancements in healthcare infrastructure and increasing investment in pain management solutions[1].

Latin America

Latin America presents growth opportunities driven by an improving healthcare system and greater accessibility to essential medicinal products[1].

Financial Impact and Cost Benefits

Cost Advantages

Studies have shown that Ketorolac Tromethamine has significant cost advantages over opiate analgesics. For instance, a retrospective cohort study found that the use of Ketorolac Tromethamine resulted in a statistically significant decrease in hospital stay lengths and reduced the use of narcotic drugs, antiemetic, and antipruritic medications. This led to reduced overall hospital costs[2].

Reduced Adverse Events

The use of Ketorolac Tromethamine is associated with reduced rates of adverse drug events, which can further lower healthcare costs and improve patient outcomes[2].

Market Challenges

Regulatory Challenges

Strict regulations and approval processes from health authorities can hinder the introduction of new formulations or generics. This regulatory environment can be a significant barrier to market growth[1].

Adverse Effects

Potential side effects, such as gastrointestinal bleeding or kidney damage, may limit the use and acceptance of Ketorolac Tromethamine among healthcare providers. These risks need to be carefully managed through proper patient selection and monitoring[1].

Competition from Alternatives

The presence of other NSAIDs and pain management options can affect market demand. Evolving clinical guidelines and preferences for alternative therapies can shift demand away from Ketorolac Tromethamine[1].

Market Saturation

As a well-established drug, the market may be saturated with existing products, making it harder for new entrants to gain a foothold. This saturation can limit the growth potential for new players[1].

Cost Constraints

Economic factors, including pricing pressures from healthcare providers and insurers, may impact profitability. The affordability of the medication is crucial in maintaining market share[1].

Key Players in the Market

The major players in the Ketorolac Tromethamine market include:

• Pfizer Inc.
• Fresenius Kabi AG
• Hikma Pharmaceuticals PLC
• Mylan N.V.
• Sandoz International GmbH
• Teva Pharmaceutical Industries Ltd.
• B. Braun Melsungen AG
• Sun Pharmaceutical Industries Ltd.
• Apotex Inc.
• Amgen Inc.[1]

Recent Market Developments

Dr. Reddy's Laboratories and Senores Pharmaceuticals, Inc. recently announced the launch of Ketorolac Tromethamine Tablets USP, 10 mg, in the U.S. market. This launch aims to create affordable access to this product and expand the portfolio in the U.S. market[3].

Conclusion

The Ketorolac Tromethamine market is poised for continued growth driven by increasing pain management needs, advancements in formulations, and growing awareness among healthcare providers and patients. However, the market also faces challenges such as regulatory hurdles, adverse effects, and competition from alternative therapies.

Key Takeaways

• The Ketorolac Tromethamine market is projected to reach USD 139.01 billion by 2031, growing at a CAGR of 3.8%.
• Increasing pain management needs and surgical procedures are key drivers of market growth.
• Advancements in drug delivery systems and regulatory approvals are crucial for market expansion.
• The market faces challenges such as regulatory hurdles, adverse effects, and competition from alternatives.
• Key players include major pharmaceutical companies like Pfizer Inc. and Teva Pharmaceutical Industries Ltd.

FAQs

Q: What is the projected market size of Ketorolac Tromethamine by 2031? A: The Ketorolac Tromethamine market is projected to reach USD 139.01 billion by 2031[1][4].

Q: What are the main drivers of the Ketorolac Tromethamine market? A: The main drivers include increasing pain management needs, rising surgical procedures, and advancements in drug delivery systems[1][4].

Q: How does Ketorolac Tromethamine impact hospital costs? A: Studies have shown that Ketorolac Tromethamine reduces hospital stay lengths, usage of narcotic drugs, and overall hospital costs due to its narcotic-sparing effects[2].

Q: Which regions are expected to see significant growth in the Ketorolac Tromethamine market? A: North America, Europe, and the Asia-Pacific region are expected to see significant growth due to various market dynamics and healthcare infrastructure improvements[1].

Q: What are some of the challenges faced by the Ketorolac Tromethamine market? A: Challenges include regulatory hurdles, potential adverse effects, competition from alternative therapies, and market saturation[1].

Sources

1. Verified Market Research - Ketorolac Tromethamine Market Trends, Size & Forecast
2. PubMed - Evaluation of the financial impact of ketorolac tromethamine therapy
3. Biospace - Dr. Reddy's Laboratories and Senores Pharmaceuticals, Inc. Announce the Launch of Ketorolac Tromethamine Tablets USP, 10 mg, in the U.S. Market
4. Market Research Intellect - Ketorolac Tromethamine Market Size and Projections
5. MDPI - Nonsteroidal Anti-Inflammatory Drug Injections versus Steroid Injections