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-three 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
Germany	69206345
Italy	1250691	COMPOSIZIONI TERAPEUTICHE PER SOMMINISTRAZIONE INTRANASALE COMPRENDENTI KETOROLAC.
Japan	H05194215	THERAPEUTIC COMPOSITION FOR NARIAL ADMINISTRATION CONTAINING 5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIDINE- 1-CARBOXYLIC ACID
Japan	3586735
Austria	130758
Denmark	0524587

Supplementary Protection Certificates for SPRIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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
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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730

Market Dynamics and Financial Trajectory for SPRIX

Last updated: July 27, 2025

Introduction

SPRIX (ketorolac injection), developed by Mallinckrodt Pharmaceuticals, is an NSAID analgesic primarily indicated for short-term management of pain severe enough to require opioid analgesics but where alternative treatments are inadequate. Having secured FDA approval in 2009, SPRIX occupies a unique niche in perioperative pain management, combining efficacy with a non-opioid profile. This report examines the evolving market landscape, competitive influences, prescribing patterns, reimbursement environment, and revenue forecast for SPRIX, providing essential insights for stakeholders.

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Market Landscape and Therapeutic Positioning

SPRIX addresses an unmet need for non-opioid analgesics in perioperative care, especially amid rising scrutiny of opioid usage and regulation. As healthcare systems worldwide implement opioid-sparing protocols, the demand for alternative pain management options intensifies. The drug’s efficacy in managing moderate to severe pain, coupled with its injectable route, makes it appealing for postoperative settings, including hospitals and ambulatory surgery centers.

The therapeutic space for SPRIX overlaps primarily with opioid analgesics and other NSAIDs like diclofenac and ketorolac administered via alternative routes. Although opioids remain dominant in managing severe postoperative pain, regulatory pressures and the opioid epidemic have galvanized efforts toward non-opioid avenues, bolstering demand for drugs like SPRIX.

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Market Dynamics Influencing SPRIX

1. Regulatory and Policy Trends

Stringent regulations on opioid prescriptions—such as CDC's opioid prescribing guidelines—have favored non-opioid pain therapies. As a result, hospitals seek to incorporate NSAIDs like SPRIX into multimodal analgesia protocols to reduce opioid reliance. Future regulatory initiatives aimed at limiting opioid prescriptions could further position SPRIX favorably, provided safety concerns over NSAIDs (e.g., gastrointestinal or renal risks) are efficiently managed.

2. Prescribing Trends and Clinical Adoption

Adoption of SPRIX depends on clinician familiarity and institutional protocols. Hospitals aiming to minimize opioid use often incorporate SPRIX into perioperative pain regimens. However, its adoption is limited by constraints such as contraindications in NSAID-sensitive patients, potential side effects, and the need for IV administration, which may restrict its use compared to oral NSAIDs.

3. Competitive Landscape

SPRIX’s primary competitors include other NSAID formulations, regional anesthetic techniques, and non-opioid analgesics. Notably, newer modalities like liposomal bupivacaine and non-opioid multimodal protocols challenge SPRIX's market share. Additionally, the rising use of multimodal opioid-sparing strategies reduces exclusive reliance on injectable NSAIDs, impacting demand.

4. Pricing and Reimbursement Environment

Pricing strategies and reimbursement policies directly impact revenue. SPRIX commands premium pricing due to its injectable form and targeted indications. Reimbursement coverage variance across healthcare systems influences hospital utilization. Payer restrictions on NSAID use and prior authorization processes may further affect sales trajectories.

5. Market Penetration Factors

Limited awareness and clinician comfort influence market penetration. Educational initiatives by Mallinckrodt and key opinion leaders (KOLs) are vital for broader adoption. Moreover, integration into institutional protocols can accelerate uptake, especially when aligned with pain management guidelines emphasizing opioid reduction.

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Financial Trajectory and Revenue Potential

Historical Performance and Revenue Trends

Since its launch, SPRIX has maintained a niche status, with annual sales estimated around $25-$50 million globally (exact data varies by source and region). Its growth trajectory has been modest, constrained by limited clinical adoption and competitive threats. However, during the COVID-19 pandemic, elective surgeries declined, negatively impacting post-op pain medication sales, including SPRIX.

Projected Growth Factors

• Regulatory and Policy Shifts: Continued emphasis on opioid alternatives can stimulate demand for SPRIX, especially in North America and Europe.
• Institutional Adoption: Expansion into outpatient and ambulatory surgery centers widens potential markets.
• Global Market Expansion: Increasing surgical procedures in emerging markets and adapting to local regulatory frameworks open new revenue streams.
• Innovation and Formulation Enhancements: Potential development of similar formulations or combination therapies could yield incremental growth.

Forecasted Revenue Outlook (2023–2028)

Considering current market dynamics, global healthcare trends favoring opioid-sparing analgesia, and renewed focus on perioperative pain management, SPRIX's revenue might experience a compound annual growth rate (CAGR) of approximately 3-5%. Potentially, revenues could rise to $60-$80 million annually by 2028 if adoption accelerates, especially with expanded clinical guidelines endorsing NSAID-based multimodal analgesia.

However, challenges such as competition from novel analgesics and safety concerns could temper growth. Strategic marketing, clinician education, and evidence generation are critical for realizing this growth horizon.

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Strategic Considerations and Market Opportunities

• Clinical Evidence Expansion: Investing in post-marketing studies demonstrating safety and efficacy can drive clinician confidence.
• Partnerships and Education: Collaborations with surgical societies and KOLs are essential to embed SPRIX within clinical pathways.
• Expanding Indications: Exploring use in additional pain settings, such as orthopedic procedures or chronic pain, can broaden revenue sources.
• Digital and Data-driven Marketing: Leveraging electronic health records and analytics to identify prescribing patterns enables targeted interventions.

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Risks and Challenges

• Safety Profile Concerns: Risk of NSAID-associated adverse events like bleeding, cardiovascular, and renal complications may restrict use.
• Competitive Pressures: Entry of innovative non-opioid analgesics, including non-injectable NSAIDs or nerve blocks, can displace SPRIX.
• Pricing Pressures: Payers' cost containment strategies may limit reimbursement, impacting margins.
• Regulatory Constraints: Future restrictions on NSAID use in certain populations could limit market size.

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Conclusion

SPRIX remains a specialized, albeit niche, player in perioperative pain management, with its financial trajectory closely linked to broader shifts toward opioid-sparing protocols. While growth prospects are moderate, strategic positioning—particularly through evidence generation, educational outreach, and expansion into emerging markets—can unlock additional revenue potential. Navigating safety concerns, competitive threats, and reimbursement challenges will be critical for maximizing future profitability.

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Key Takeaways

• Market potential hinges on increasing adoption of NSAIDs as opioid alternatives, especially amidst regulatory pushes to reduce opioid prescriptions.
• Growth prospects are modest but steady, with a projected CAGR of 3-5%, reaching up to $80 million annually by 2028.
• Clinical education and evidence development are vital to overcome adoption barriers and expand use cases.
• Competitive landscape remains intense, with technological advances and alternative modalities posing ongoing threats.
• Regulatory and safety considerations will influence market dynamics, necessitating vigilant health authority engagement.

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FAQs

1. What factors influence the adoption of SPRIX in clinical settings?
Clinician familiarity, institutional protocols emphasizing opioid reduction, reimbursement policies, and safety profile considerations largely guide SPRIX’s adoption.

2. How does the opioid epidemic impact demand for SPRIX?
Regulatory efforts to curb opioid prescriptions promote non-opioid alternatives like SPRIX, potentially increasing demand, provided safety concerns are properly managed.

3. What are the main competitors to SPRIX?
Other NSAID formulations, regional anesthesia techniques, and emerging non-opioid analgesics such as liposomal bupivacaine.

4. What are the key risks facing SPRIX's market growth?
Safety concerns over NSAID-related adverse events, competition from newer modalities, pricing pressures, and restrictive reimbursement policies.

5. How might global market expansion influence SPRIX’s revenue?
Emerging markets with increasing surgical procedures and regulatory environments favoring non-opioid pain management can provide significant growth opportunities.

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References

1. [1] Mallinckrodt Pharmaceuticals. (2009). FDA approval of SPRIX (ketorolac injection).
2. [2] CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.
3. [3] Market reports on NSAID and perioperative analgesic drug sales (Various, 2022-2023).
4. [4] Recent industry analyses and sales estimates by IQVIA and EvaluatePharma.
5. [5] Clinical guidelines on multimodal pain management and NSAID usage.

Note: Data and projections are based on industry estimates, market reports, and publicly available information as of early 2023.