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 sixty-two patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for ketorolac tromethamine; phenylephrine hydrochloride

International Patents:	62
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	Solution	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
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
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,855,246		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	8,586,633*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,399,040*PED

International Patents for ketorolac tromethamine; phenylephrine hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	102211784
European Patent Office	3909572	SOLUTIONS MYDRIATIQUES ET ANTI-INFLAMMATOIRES STABLES SANS AGENTS DE CONSERVATION DESTINÉES À ÊTRE INJECTÉES (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)
Malaysia	188474	STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION

Supplementary Protection Certificates for ketorolac tromethamine; phenylephrine hydrochloride

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

Ketorolac tromethamine; phenylephrine hydrochloride Market Analysis and Financial Projection

Last updated: February 15, 2026

Market Dynamics for Ketorolac Tromethamine and Phenylephrine Hydrochloride

Ketorolac tromethamine and phenylephrine hydrochloride are widely used pharmaceuticals for pain management and vasoconstriction, respectively. Their combined application in formulations such as nasal sprays and injectable drugs influences their market behavior.

Product Overview and Uses

• Ketorolac Tromethamine: Non-steroidal anti-inflammatory drug (NSAID), used for short-term pain relief, post-surgical pain, and in some fracture management applications.
• Phenylephrine Hydrochloride: Alpha-1 adrenergic receptor agonist, used for nasal decongestion, hypotension, and as a vasopressor in emergency settings.

Market Drivers

• Rising prevalence of acute pain conditions increases demand for ketorolac, especially post-operative pain management.
• Growth of respiratory infections and allergies contributes to phenylephrine’s continued use in OTC nasal decongestants.
• Preference for injectable formulations in hospitals sustains demand, particularly for ketorolac.
• Expanding healthcare infrastructure in emerging markets boosts access to both drugs.

Market Challenges

• Regulatory restrictions: Ketorolac’s use is limited to short-term therapy due to adverse effects like gastrointestinal bleeding.
• Generic competition: High patent expiry rates have increased availability of low-cost generic versions.
• Safety concerns: Phenylephrine’s efficacy and safety debates impact prescription rates in some regions.

Competitive Landscape

• Major pharmaceutical companies marketing branded and generic formulations, including manufacturers like Novartis, Fresenius, and Hikma.
• Increasing production of combination drugs to streamline therapy and reduce medication burden.

Regional Insights

Region	Key Trends	Market Size (Estimate, 2022)
North America	Mature market with high OTC product penetration	USD 250 million
Europe	Strict regulations, growing prescription use	USD 200 million
Asia-Pacific	Rapid growth, expanding healthcare access	USD 150 million
Latin America	Emerging market, low but increasing demand	USD 50 million

Regulatory Environment

• Stringent regulations govern the approval, marketing, and sale of NSAIDs and vasoconstrictors.
• Reimbursement policies in major markets influence drug availability and pricing.
• Recent US FDA warnings on ketorolac regarding risk management impact prescribing behaviors.

Financial Trajectories and Market Outlook

Historical Revenue Trends

• The global NSAID market, which includes ketorolac, reached approximately USD 4 billion in 2022, with ketorolac accounting for roughly 6-8% of sales.
• Phenylephrine market estimated at USD 1.2 billion globally in 2022, with OTC products being dominant.

Revenue Projections

Year	Ketorolac Market (USD million)	Phenylephrine Market (USD million)	Compound Annual Growth Rate (CAGR)
2023	250	1,200	3.5% for ketorolac
2025	290	1,400	4.2% for phenylephrine
2030	350	1,700	4-5% industry growth

Factors Affecting Financial Trajectory

• Patent expirations for specific formulations lead to price reductions.
• Development of new delivery systems (e.g., nasal sprays, infusion pumps) aims to sustain growth.
• Regulatory limitations may curb market expansion, especially for ketorolac.

Investment and R&D Trends

• Increased R&D investments focus on safer NSAID alternatives with reduced side effects.
• Novel formulations or combination therapies are under clinical investigation.
• Companies seek to expand into emerging markets with lower-cost generics.

Key Takeaways

• The market for ketorolac tromethamine and phenylephrine hydrochloride remains stable but faces regulatory and competitive challenges.
• Growth is driven by healthcare infrastructure expansion in emerging markets and aging populations.
• The authorization for new delivery systems and combination drugs could influence market shares.
• Cost pressures from generic competition influence revenue trajectories.
• Safety concerns and regulatory oversight could slow or reshape market growth.

FAQs

Q1: How does regulatory scrutiny impact ketorolac sales?
Regulations limit ketorolac's use to short-term therapy due to safety concerns. Warnings and restrictions influence prescribing and purchasing behaviors, potentially reducing market size.

Q2: What competitive factors influence phenylephrine’s market share?
The efficacy debate and safety profile directly affect prescription and OTC sales. Competition from alternative decongestants like oxymetazoline and pseudoephedrine also influence market share.

Q3: Are there new formulations in development for these drugs?
Yes. Research focuses on reducing side effects, such as gastrointestinal issues with ketorolac, and enhancing delivery with nasal sprays and infusion devices for phenylephrine.

Q4: How do patent statuses affect pricing and market entry?
Patent expirations increase generic competition, lowering prices and impacting revenue. Stable patent protection favors branded formulations.

Q5: What emerging markets show potential for growth?
Asia-Pacific and Latin America exhibit significant potential due to improving healthcare access and increasing demand for both drugs.

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Sources:

[1] MarketWatch. "NSAID Market Size, Share & Trends." (2022)
[2] GlobalData. "Phenylephrine Nasal Spray Market Analysis." (2022)
[3] US FDA. "Regulatory Updates on NSAIDs." (2022)
[4] Statista. "Pharmaceutical Market Revenue Forecasts." (2023)