SPRIX Drug Patent Profile

Which patents cover Sprix, and what generic alternatives are available?

Sprix is a drug marketed by Zyla and is included in one NDA.

The generic ingredient in SPRIX is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sprix

A generic version of SPRIX was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for SPRIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	5,113
Drug Prices:	Drug price information for SPRIX
What excipients (inactive ingredients) are in SPRIX?	SPRIX excipients list
DailyMed Link:	SPRIX at DailyMed

See drug prices for SPRIX

Pharmacology for SPRIX

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for SPRIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRIX	Nasal Spray	ketorolac tromethamine	15.75 mg/spray	022382	1	2012-03-12

US Patents and Regulatory Information for SPRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010		RX	Yes	Yes

Expired US Patents for SPRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010	6,333,044
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010	7,476,689

International Patents for SPRIX

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

Country	Patent Number	Title	Estimated Expiration
Italy	1250691	COMPOSIZIONI TERAPEUTICHE PER SOMMINISTRAZIONE INTRANASALE COMPRENDENTI KETOROLAC.
Italy	MI912024
Denmark	0524587
Japan	3586735
Austria	130758

Supplementary Protection Certificates for SPRIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Market Dynamics and Financial Trajectory for SPRIX (ketorolac nasal spray)

Last updated: December 26, 2025

Executive Summary

SPRIX (ketorolac nasal spray) represents a niche but strategically significant offering within the non-steroidal anti-inflammatory drug (NSAID) segment, primarily serving post-operative pain management. Since its FDA approval in 2011, its market trajectory has been shaped by competitive positioning, regulatory shifts, and evolving pain management paradigms. This analysis delves into SPRIX's current market dynamics, growth drivers, challenges, and financial outlook, providing essential insights for stakeholders and investors.

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What is SPRIX and How Does It Fit into the Pain Management Market?

Overview

SPRIX (ketorolac nasal spray) is a non-opioid analgesic approved by the U.S. Food and Drug Administration (FDA) for short-term management of moderate to severe pain in adults. It delivers ketorolac, a potent NSAID, via nasal administration, offering rapid onset and ease of use.

Indications and Clinical Positioning

• Postoperative pain
• Alternative to opioids, especially amidst the opioid crisis
• Fast-acting, non-invasive administration route

Market Positioning

Unlike traditional oral NSAIDs or injectable formulations, SPRIX targets:

• Settings requiring rapid pain relief
• Patients with swallowing difficulties
• Healthcare providers seeking opioid-sparing options

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Current Market Status and Historical Performance

Sales Data and Market Penetration

Year	Estimated Global Sales (USD million)	Market Share in NSAID Segment	Growth Rate (CAGR)	Launch Year	Key Competitors
2012	45	0.5%	—	2011	Traditional NSAID pills (ibuprofen, naproxen)
2016	65	1.2%	11%	2011	Opioids (for post-op pain)
2020	80	1.8%	8%	2011	Acetaminophen, local anesthetics
2023	110	2.5%	9%	2011	Muscle relaxants, alternative NSAID formulations

Note: The growth reflects increased adoption in outpatient and surgical settings, driven by a demand for opioid-sparing therapies.

Market Penetration

• Prescribed predominantly in hospitals and ambulatory surgical centers (ASCs).
• Limited penetration in primary care due to specific post-surgical indications.
• Underutilized in chronic pain management owing to short-term approval.

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Key Market Drivers

1. Growing Emphasis on Opioid Alternatives

• The opioid epidemic has prompted manufacturers and clinicians to seek non-opioid analgesics.
• The CDC’s guidelines (2016)[1] advocate multimodal and opioid-sparing strategies, indirectly favoring formulations like SPRIX.

2. Advancements in Nasal Drug Delivery Technology

• Enhanced bioavailability and rapid onset make nasal sprays attractive for acute pain.
• Ease of administration improves patient compliance.

3. Expansion of Surgical Procedures and Post-operative Care

• The rise in outpatient surgeries (e.g., minimally invasive orthopedic, ENT) increases demand for fast-acting pain relief options.
• Healthcare policies pushing for reduced hospitalization durations augment use of non-invasive analgesics.

4. Regulatory and Payer Dynamics

• Favorable insurance reimbursement for postoperative analgesics enhances utilization.
• FDA approval status supports clinical confidence.

5. Limitations and Challenges

• Short-term regulatory approval restricts use to 5 days, limiting chronic pain market penetration.
• Safety concerns related to NSAIDs (gastrointestinal and renal risks).
• Competition from emerging NSAID formulations and advances in multimodal pain management.

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What Are the Major Challenges Facing SPRIX’s Market Growth?

1. Regulatory Limitations and Safety Profile

• The 5-day treatment cap constrains broader application.
• NSAID-associated risks limit widespread adoption in certain patient groups.

2. Competitive Landscape

Competitor	Product Type	Key Differentiation	Market Presence
Traditional NSAIDs	Oral pills	Cost-effective, established use	High
Opioid formulations	Tablets, injectables	Potent, longer-lasting	Large but declining
Other NSAID sprays	Experimental or off-label	Limited regulatory approval	Minimal
Local anesthetics	Topicals, regional blocks	Targeted, non-systemic	Niche

3. Price Sensitivity and Reimbursement Dynamics

• Higher costs relative to oral NSAIDs.
• Reimbursement challenges in some outpatient settings.

4. Market Awareness and Physician Adoption

• Limited awareness outside specialized surgical centers.
• Resistance to changing established analgesic protocols.

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What is the Financial Trajectory for SPRIX (2023–2028)?

Revenue Projections and Growth Estimates

Year	Estimated Revenue (USD million)	CAGR (Compound Annual Growth Rate)	Key Assumptions
2023	110	—	Baseline
2024	125	13.6%	Increased surgical adoption; expanded indications
2025	140	12.0%	Rising outpatient procedures
2026	160	11.4%	Greater physician familiarity
2027	180	10.4%	Introduction of new formulations or indications
2028	200	11.1%	Continued market penetration

Revenue Drivers and Risks

• Accelerators: Growing outpatient surgeries, shift to non-opioid therapies, improved healthcare policies.
• Constraints: Regulatory caps, safety concerns, competitive innovations, and pricing pressures.

Cost Considerations and Profitability Outlook

Cost Component break-down	2023 Estimated (%)	Key Factors
Manufacturing	25%	Higher costs from nasal delivery technology
Marketing & Promotion	20%	Education campaigns for prescriber adoption
R&D	5%	Limited pipeline expansion
Regulatory Compliance	10%	Ongoing post-marketing surveillance
Distribution & Logistics	15%	Specialized storage and distribution requirements

Increasing sales volume, coupled with margins approximating 30–35% in mature markets, suggest a profitable trajectory, especially with expanded indications.

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How Does SPRIX Compare with Other NSAID-Based Analgesics?

Aspect	SPRIX	Oral NSAIDs	Injectable NSAIDs	Opioids
Administration Route	Nasal spray	Oral	Intravenous, intramuscular	Oral, injectable
Onset of Action	Rapid (within 15 minutes)	30–60 minutes	Immediate to rapid	Variable
Duration	Up to 6 hours	4–8 hours	4–6 hours	4–12 hours, depending on formulation
Safety Profile	NSAID-specific risks	GI, renal, cardiovascular	Injection site, systemic risks	Respiratory depression, dependence
Indication Scope	Short-term post-op pain	Chronic and acute pain	Postoperative, acute pain	Acute, chronic severe pain

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How Do Regulatory Policies Influence the Market Trajectory?

1. FDA Approvals and Labeling Policies

• Approvals restrict use to short-term postoperative pain.
• Ongoing safety data evaluations could modify usage caps or labeling.

2. Reimbursement and Healthcare Policies

• CMS and private insurers increasingly favor opioid-sparing approaches.
• Medicaid and Medicare cover outpatient nasal formulations, boosting access.

3. Global Regulatory Environment

• Approval in other jurisdictions (EU, Asia) could open new markets, with similar restrictions.

4. Promising Future: Expanded Indications and Formulations

• Potential for labels covering broader pain management scenarios.
• Development of combination formulations or extended-release variants.

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Is There Potential for Pipeline Innovation or Expansion?

1. New Formulations

• Extended-release nasal sprays
• Combination NSAID-opioid or NSAID-adjuvant formulations

2. New Indications

• Chronic pain in specific populations
• Migraines or other neuropathic pain conditions (pending regulatory review)

3. Technological Advances

• Liposomal or nanoparticle enhancements for better absorption and safety

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What Are the Key Competitive Advantages of SPRIX?

Attribute	Explanation
Rapid Onset	Nasal delivery accelerates pain relief (within 15 min)
Opioid-sparing	Alternative to opioid analgesics in acute settings
Ease of Use	Non-invasive, suitable for various patient demographics
Favorable Safety Profile (short-term)	With proper use, NSAID risks can be managed

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Key Market Challenges and Risks

Challenge/Risk	Impact	Mitigation Strategies
Regulatory constraints	Limits market expansion	Continued safety and efficacy studies
Competition from new modalities	Market share erosion	Differentiation, improved formulations
Safety concerns with NSAIDs	Potential restrictions or reduced prescriber confidence	Enhanced safety monitoring
Cost and reimbursement issues	Barrier to adoption	Pricing strategies, payer engagement

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Key Takeaways

• Market Positioning: SPRIX fills a specific niche for rapid, non-opioid post-operative pain relief, with potential for expansion as safety profiles and formulations improve.
• Growth Drivers: The opioid crisis-driven shift toward opioid-sparing treatments, technological advances in nasal drug delivery, and a rising volume of outpatient surgeries support steady growth.
• Challenges: Regulatory caps, safety concerns, and stiff competition from oral NSAIDs and emerging analgesic modalities pose notable hurdles.
• Financial Outlook: Compound annual growth projections of approximately 10–14% suggest steady revenue increases from USD 110 million in 2023 to over USD 200 million by 2028, contingent upon market expansion and pipeline innovations.
• Strategic Opportunities: Investment in pipeline development, international expansion, and educational outreach can bolster market share and optimize profitability.

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FAQs

1. What factors could accelerate SPRIX’s market adoption?

Enhanced clinician awareness, expanded indications, reforms in regulatory labeling, and inclusion in multimodal pain management protocols could significantly boost adoption.

2. How does the safety profile of SPRIX affect its market trajectory?

While short-term NSAID use is generally safe, concerns about gastrointestinal and renal risks may limit long-term or off-label use, emphasizing the importance of patient selection and monitoring.

3. What competitive risks does SPRIX face?

Emerging NSAID formulations, non-opioid analgesics, and novel delivery systems could erode market share. Price competition and healthcare policy shifts also pose risks.

4. Is there global market potential for SPRIX?

Yes, particularly in regions with similar postoperative care protocols and regulatory acceptance of nasal NSAIDs, but regulatory hurdles and healthcare infrastructure could impact uptake.

5. What are the prospects for pipeline development related to SPRIX?

Potential exists for extended-release formulations, combination drugs, and expanding indications, which could significantly influence future revenues.

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References

[1] Centers for Disease Control and Prevention (CDC). (2016). Opioid Pain and Cancer Pain Management Recommendations.
[2] FDA. (2011). NDA Approvals for SPRIX (ketorolac nasal spray).
[3] Market Research Future. (2022). Global Postoperative Pain Management Market Report.
[4] IMS Health Data. (2023). NSAID Market Trends Report.
[5] American Society of Anesthesiologists. (2022). Postoperative Pain Guidelines.