KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for ketorolac tromethamine; phenylephrine hydrochloride and what is the scope of patent protection?

Ketorolac tromethamine; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Lupin Ltd and Rayner Surgical, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine; phenylephrine hydrochloride has eighty-five patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

International Patents:	85
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
DailyMed Link:	KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE at DailyMed

Pharmacology for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMIDRIA	Injection	ketorolac tromethamine; phenylephrine hydrochloride	1%/0.3%	205388	1	2015-05-29

US Patents and Regulatory Information for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

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	8,586,633*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,066,856*PED				Y
Lupin Ltd	KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	210183-001	Jul 1, 2019	AT	RX	No	No
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,486,406*PED				Y

Expired US Patents for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	8,173,707*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,399,040*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,278,101*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	8,586,633*PED

International Patents for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2020012591	SOLUCIONES MIDRIATICAS Y ANTIINFLAMATORIAS INYECTABLES, ESTABLES Y LIBRES DE CONSERVANTES. (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION.)
Netherlands	300784
Eurasian Patent Organization	201590807	СТАБИЛЬНЫЕ БЕСКОНСЕРВАНТНЫЕ МИДРИАТИЧЕСКИЕ И ПРОТИВОВОСПАЛИТЕЛЬНЫЕ РАСТВОРЫ ДЛЯ ИНЪЕКЦИЙ
Hungary	E055537

Supplementary Protection Certificates for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	C20150054 00179	Estonia		PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313	647	Finland
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	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

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ketorolac Tromethamine and Phenylephrine/Ketorolac Combination

Introduction

Ketorolac tromethamine, a potent nonsteroidal anti-inflammatory drug (NSAID), and its combination with phenylephrine hydrochloride, are significant players in the pain management and ophthalmic surgery markets. Here, we delve into the market dynamics, financial trajectory, and key factors influencing these medications.

Global Ketorolac Tromethamine Market

Market Size and Growth

The global ketorolac tromethamine market is substantial and growing. As of 2024, the market size is estimated at USD 725.2 million, with a projected compound annual growth rate (CAGR) of 11.50% from 2024 to 2031, reaching USD 1,553.75 million by 2031[1].

Regional Market Segmentation

The market is segmented geographically, with North America dominating, accounting for around 40% of the global revenue in 2024. This region is driven by increasing surgical procedures, rising chronic pain incidence, and a robust pharmaceutical industry[1].

• North America: Expected to grow at a CAGR of 9.7% from 2024 to 2031.
• Europe: The fastest-growing region, with a CAGR of 10.0% from 2024 to 2031.
• Asia-Pacific: Growing at a CAGR of 13.5% from 2024 to 2031, driven by increasing awareness of pain management and expanding healthcare access.
• Latin America: Expected to grow at a CAGR of 10.9% from 2024 to 2031.
• Middle East and Africa: Growing at a CAGR of 11.2% from 2024 to 2031, influenced by advancements in healthcare infrastructure[1].

Drivers of Market Growth

The market is driven by several key factors:

• Increasing Surgical Procedures: The rise in surgical operations worldwide increases the demand for effective pain management solutions.
• Chronic Pain Incidence: Growing prevalence of chronic pain disorders fuels the need for NSAIDs like ketorolac tromethamine.
• Research and Development: Ongoing R&D initiatives to enhance drug formulations and delivery systems support market growth[3][4].

Financial Impact of Ketorolac Tromethamine

Cost Savings and Resource Utilization

Studies have shown that ketorolac tromethamine has significant cost advantages over opiate analgesics. A retrospective cohort study found that ketorolac use was associated with reduced lengths of stay, lower usage of narcotic drugs, and fewer adverse events, leading to overall reduced hospital costs[2].

Economic Benefits in Pain Management

Ketorolac tromethamine's narcotic-sparing effects and reduced rates of adverse drug events contribute to its economic benefits. This is particularly evident in postoperative pain management, where it reduces the need for antiemetic and antipruritic medications, thereby lowering overall healthcare costs[2].

Phenylephrine/Ketorolac Combination in Ophthalmic Surgery

Market Context

The combination of phenylephrine and ketorolac, known as Omidria, is used in ophthalmic surgery, particularly in cataract procedures. This combination offers significant benefits in terms of reduced iris manipulation and cost savings in certain settings.

Financial Impact in ASC and HOPD Settings

A cost-analysis study revealed that the use of Omidria in Ambulatory Surgery Center (ASC) settings resulted in cost savings of $106,225 per year due to separate insurance reimbursement. However, in Hospital Outpatient Department (HOPD) settings, the use of Omidria increased facility costs due to lack of insurance reimbursement[5].

Clinical Benefits

The use of Omidria reduces the need for pupillary dilation devices by 83%, which can lead to smoother and more efficient surgical procedures. This reduction in iris manipulation is a significant clinical benefit, enhancing patient outcomes and surgical efficiency[5].

Key Players in the Market

The ketorolac tromethamine market is dominated by several major pharmaceutical companies:

• 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.[4].

Regulatory and Healthcare Infrastructure Influence

The growth of the ketorolac tromethamine market is also influenced by regulatory environments and healthcare infrastructure. In regions like Europe, stringent regulatory requirements ensure the quality and safety of pharmaceutical products, fostering market growth. Advanced healthcare systems in North America and expanding healthcare access in Asia-Pacific further support the market's expansion[1][4].

Challenges and Opportunities

Impact of COVID-19

The COVID-19 pandemic presented significant challenges, including supply chain disruptions, reduced healthcare facility visits, and delayed surgical procedures. However, the market showed resilience due to the drug's critical role in pain management protocols. As healthcare systems adapt to pandemic conditions, the market is expected to recover and grow[1].

Future Growth Opportunities

The ongoing vaccination efforts and healthcare system adaptations will continue to shape the market trajectory. Increasing awareness about pain management, expanding healthcare access, and advancements in drug formulations and delivery systems offer substantial growth opportunities[1][3].

Key Takeaways

• The global ketorolac tromethamine market is projected to grow significantly, driven by increasing surgical procedures and chronic pain incidence.
• The market is segmented geographically, with North America and Europe being key regions.
• Ketorolac tromethamine offers significant cost advantages over opiate analgesics.
• The phenylephrine/ketorolac combination (Omidria) provides clinical and financial benefits in ophthalmic surgery.
• Major pharmaceutical companies dominate the market, and regulatory environments play a crucial role in market growth.

FAQs

What is the current market size of ketorolac tromethamine?

The global ketorolac tromethamine market size is estimated at USD 725.2 million in 2024[1].

What is the projected growth rate of the ketorolac tromethamine market?

The market is expected to grow at a CAGR of 11.50% from 2024 to 2031[1].

How does the phenylephrine/ketorolac combination impact costs in ophthalmic surgery?

The use of Omidria in ASC settings can result in cost savings, but it may increase costs in HOPD settings due to lack of insurance reimbursement[5].

What are the key drivers of the ketorolac tromethamine market?

The market is driven by increasing surgical procedures, rising chronic pain incidence, and ongoing R&D initiatives[3][4].

Which regions are expected to see the fastest growth in the ketorolac tromethamine market?

Europe is expected to be the fastest-growing region, followed by the Asia-Pacific region[1].

Sources

1. Cognitive Market Research: Ketorolac Tromethamine Market Report 2024 (Global Edition)
2. PubMed: Evaluation of the financial impact of ketorolac tromethamine therapy
3. Market Research Intellect: Global Ketorolac Tromethamine Market Size and Projections
4. Verified Market Research: Ketorolac Tromethamine Market Trends, Size & Forecast
5. IOVS: The Financial Impact of Phenylephrine/Ketorolac in Routine Cataract Surgery