Ketorolac tromethamine; phenylephrine hydrochloride - Generic Drug Details

What are the generic drug sources for ketorolac tromethamine; phenylephrine hydrochloride and what is the scope of freedom to operate?

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 three 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 fifty-nine patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for ketorolac tromethamine; phenylephrine hydrochloride

International Patents:	59
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	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

Recent Clinical Trials for ketorolac tromethamine; phenylephrine hydrochloride

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

Sponsor	Phase
The Second People's Hospital of Huai'an	PHASE1

See all ketorolac tromethamine; phenylephrine hydrochloride clinical trials

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					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					Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes			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
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014

International Patents for ketorolac tromethamine; phenylephrine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Argentina	093115	SOLUCIONES MIDRIATICAS Y ANTIINFLAMATORIAS INYECTABLES, ESTABLES Y LIBRES DE CONSERVANTES
Japan	2019081798	安定で保存剤非含有の散瞳および抗炎症注射用液剤 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)
Hungary	E055537
Chile	2015001078	Una formulacion farmaceutica liquida y esteril que comprende fenilefrina, ketorolaco y un sistema tamponante en un vehiculo acuoso, en donde la formulacion se encuentra libre de conservantes y de antioxidantes y es estable durante al menos seis meses almacenada a una temperatura de 5°c a 25°c.
Brazil	112015009228	soluções estáveis anti-inflamatórias e midriáticas livres de conservantes para injeção

Supplementary Protection Certificates for ketorolac tromethamine; phenylephrine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, 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	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

Market Dynamics and Financial Trajectory for Ketorolac Tromethamine; Phenylephrine Hydrochloride

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for combination formulations such as Ketorolac Tromethamine and Phenylephrine Hydrochloride reflects evolving clinical practices, regulatory frameworks, and market demands. Both compounds occupy crucial positions within analgesic and vasoconstrictive therapy domains respectively. Understanding their market dynamics and financial trajectory involves analyzing key drivers, regulatory considerations, competitive landscape, and emerging opportunities.

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Pharmacological Profile and Therapeutic Applications

Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) primarily used for short-term management of moderate to severe acute pain. Its potent analgesic properties rival opioids but with a lower dependency risk, making it a preferred choice in postoperative and emergency settings.

Phenylephrine Hydrochloride functions chiefly as a selective alpha-1 adrenergic receptor agonist. It induces vasoconstriction, commonly employed for nasal decongestion, hypotension management, and as a component in combination therapies to enhance drug absorption or reduce bleeding.

The co-formulation of Ketorolac and Phenylephrine aligns with clinical needs for pain relief coupled with nasal congestion management, especially in conditions such as sinusitis, rhinorrhea with pain, or acute respiratory infections.

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Market Drivers

1. Rising Prevalence of Acute Pain and Sinus Conditions

Global increases in acute pain cases due to surgeries, trauma, and diseases elevate demand for effective analgesics like Ketorolac. Concurrently, sinusitis, allergic rhinitis, and respiratory infections are on the rise, boosting phenylephrine utilization. The co-formulation serves as a convenient treatment option, especially in ENT (Ear, Nose, Throat) practice.

2. Shift Toward Non-Opioid Analgesics

The opioid crisis has sparked a paradigm shift towards NSAIDs like Ketorolac, which offer effective pain management without high dependency potential. The availability of combination drugs taps into this demand, further fueled by regulatory encouragement for non-opioid alternatives.

3. Growing Preference for Combination Therapies

Clinicians favor combination formulations that address multiple symptoms or conditions simultaneously, improving patient compliance and treatment efficacy. This trend bolsters the market potential for Ketorolac-Phenylephrine combination products.

4. Regulatory Approvals and Market Expansion

Regulatory bodies, including the U.S. FDA and EMA, have approved various formulations, enabling market expansion. The approval of nasal sprays and injectable forms containing this combination has been pivotal.

5. Innovation and Formulation Advances

Enhanced drug delivery technologies (e.g., nasal sprays, pre-filled syringes) improve efficacy, patient acceptance, and adherence, supporting market growth.

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Market Challenges

1. Safety Concerns with NSAIDs

Ketorolac's association with gastrointestinal, renal, and bleeding risks limits its long-term and high-dose usage. Regulatory restrictions and warnings impact prescribing trends.

2. Regulatory Barriers and Patent Expiry

Patent expirations for existing formulations open markets for generics, intensifying competition and exerting pricing pressures.

3. Limited Indications for Combined Use

The narrow scope of approved indications restricts market expansion potential without additional clinical trials and regulatory approvals.

4. Market Penetration in Developing Countries

Limited healthcare infrastructure and regulatory hurdles hinder distribution and acceptance in emerging markets.

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Competitive Landscape

Market players include leading pharmaceutical companies with capabilities in analgesics and nasal decongestants. Major competitors are involved in the production of both branded and generic formulations, with some forging strategic partnerships or acquisitions to broaden their portfolio.

Key Players:

• Johnson & Johnson (Acuvail, Nasal spray formulations)
• Pfizer (Generic and branded NSAID products)
• Mylan (now part of Viatris)
• Sun Pharmaceutical
• AstraZeneca (Nasal decongestant products)

Emerging entrants focus on novel delivery systems, such as bioadhesive nasal gels or sustained-release formulations, aiming to carve niche markets.

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Financial Trajectory and Market Forecast

Market Size and Growth Projections

According to recent reports, the global nasal decongestants market (within which phenylephrine-based products are significant) is projected to reach USD 4.2 billion by 2027, with a CAGR of approximately 3.8% from 2022 to 2027 [1]. Simultaneously, NSAID markets, including Ketorolac, are valued in billions, with specific segments experiencing double-digit growth in emerging economies.

Influencing Factors on Revenue Streams

• Product Launches: New formulations, especially nasal sprays and injectable uses, will drive revenue.
• Regulatory Approvals: Expanded indications and off-label uses can open revenue streams.
• Patent Expiries: Lead to price erosion but increased volume sales through generics.
• Market Penetration in Developing Economies: Growing healthcare access facilitates expansion, though pricing pressures are high.

Forecasted Trends

The combination of these components is expected to favor moderate growth in their combined formulations in the short to medium term. However, growth is contingent on overcoming safety concerns, regulatory pathways, and market acceptance.

Note: The market entry of biosimilars or novel drug delivery platforms could disrupt existing trajectories, offering higher margins or cost advantages.

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Regulatory Outlook and Patent Landscape

Regulatory agencies emphasize safety data, especially for NSAIDs. Recent approvals for nasal spray formulations of phenylephrine, along with approved combinations, signal favorable regulatory climate. Patent cliffs for early formulations propel generic competition, influencing pricing strategies and profit margins.

Further, regulatory bodies are scrutinizing combination drugs for efficacy and safety, influencing submission strategies and market access timelines.

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Strategic Opportunities

• Formulation Innovation: Developing preservative-free, sustained-release, or microsphere-based nasal preparations could offer differentiation.
• Expanding Indications: Conducting clinical trials for prolonged or adjunct uses broadens commercial potential.
• Regional Focus: Targeting emerging markets with tailored pricing and distribution strategies enhances revenue.
• Partnerships and Licensing: Collaborating with regional players can accelerate market entry and compliance.

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Conclusion

The market dynamics for Ketorolac Tromethamine and Phenylephrine Hydrochloride are shaped by their therapeutic synergy, regulatory environment, and clinical trends favoring non-opioid pain relief and combination therapies. While safety concerns and patent expirations pose challenges, innovation and strategic expansion into emerging markets offer substantial growth opportunities. Companies that leverage formulation advances, navigate regulatory pathways efficiently, and target unmet needs can capitalize on the evolving landscape.

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Key Takeaways

• The demand for NSAID-based combination formulations like Ketorolac-Phenylephrine is driven by the prevalence of acute pain and sinus conditions globally.
• Regulatory shifts favor non-opioid therapies, supporting market growth but necessitating robust safety data.
• Market competition hinges on innovation, patent strategies, and regional expansion, with emerging markets presenting significant growth opportunities.
• Strategic investments in formulation technologies and indication expansion can enhance competitiveness.
• Price pressures from patent expiries and generic entries demand agile pricing and marketing strategies to preserve profitability.

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FAQs

1. What is the primary clinical advantage of Ketorolac and Phenylephrine combination formulations?
They provide simultaneous analgesic and nasal decongestant effects, improving patient compliance and convenience in managing conditions like sinusitis with associated pain.

2. Are there safety concerns associated with this combination?
Yes. Ketorolac carries risks of gastrointestinal bleeding and renal impairment, whereas phenylephrine can cause hypertension and cardiovascular side effects. Regulatory agencies require monitoring and clear guidelines to mitigate risks.

3. How does patent expiry influence the market for Ketorolac-Phenylephrine products?
Patent expirations lead to increased competition from generics, resulting in price erosion but also in wider accessibility and volume sales.

4. What are emerging trends affecting this market?
Advances in nasal delivery systems and expanding indications through clinical trials are key trends shaping future opportunities.

5. Which regions offer the most growth potential for these formulations?
Emerging markets in Asia-Pacific and Latin America present significant growth due to expanding healthcare infrastructure, increased affordability, and rising disease prevalence.

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Sources:

[1] Market Research Future, "Nasal Decongestants Market," 2022.