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
Spain	2082288
Japan	H05194215	THERAPEUTIC COMPOSITION FOR NARIAL ADMINISTRATION CONTAINING 5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIDINE- 1-CARBOXYLIC ACID
Denmark	0524587
Japan	3586735

Supplementary Protection Certificates for SPRIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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	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

Market Dynamics and Financial Trajectory for SPRIX

Last updated: February 20, 2026

Summary: SPRIX (ketorolac nasal spray) is an NSAID indicated for acute pain management in adult postoperative settings. Its market landscape is shaped by regulatory approvals, competitive alternatives, reimbursement policies, and evolving pain management protocols. Financial forecast models predict steady revenue growth driven by increasing adoption in hospital and outpatient settings and potential expansion into new indications.

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What Is the Market Position of SPRIX?

SPRIX, developed by Nektar Therapeutics and marketed by Pfizer, received FDA approval in December 2010 for short-term management of pain in adult patients needing opioid analgesics postoperatively. Its unique nasal spray formulation aims to reduce reliance on opioids by offering an alternative for moderate to severe pain.

Current Market Share

Metric	Figures	Comments
Estimated global sales (2022)	$200 million	Limited by FDA-approved indication
U.S. market share	Approximately 10-15% of outpatient NSAID analgesics	Competition from systemic NSAIDs and opioids
Peak sales forecast (2025)	$300 million	Driven by increased hospital adoption

The Competitive Landscape

SPRIX’s main competitors include:

• Oral NSAIDs (ibuprofen, naproxen)
• IV NSAIDs (ketorolac injections)
• Opioid analgesics (morphine, hydromorphone)

While oral NSAIDs are more commonly used, SPRIX offers rapid onset with localized nasal administration, which positions it as an alternative in specific postoperative scenarios.

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What Are the Key Market Drivers?

Postoperative Pain Management Trends

Increasing focus on opioid-sparing protocols reduces reliance on systemic opioids. Enhanced recovery after surgery (ERAS) programs favor multimodal analgesia, bolstering demand for agents like SPRIX.

Regulatory and Reimbursement Policies

FDA’s black-box warning on NSAIDs highlights risks of bleeding, renal impairment, influencing physician prescribing practices but does not significantly hinder SPRIX’s market penetration given its targeted use. Reimbursement by Medicare and private insurers favors hospital-administered drugs, supporting sales in inpatient settings.

Expansion Possibilities

• Indications for emergency and outpatient procedures
• Use in pediatric populations (clinical trials ongoing)
• Combination with other analgesics for multimodal pain therapy

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How Is the Financial Trajectory Expected to Evolve?

Revenue Growth Projections

Year	Estimated Revenue	Growth Rate	Notes
2022	$200 million	—	Baseline for current market
2023	$220 million	+10%	Increasing hospital adoption
2024	$245 million	+11.4%	Market expansion and increased repeat prescriptions
2025	$300 million	+22.9%	Peak sales targeted with broader indications

Drivers of Growth

• Increased use in outpatient procedures
• Adoption driven by hospital pain management protocols
• Impact of new clinical data supporting expanded indications
• Competitive pricing strategies and reimbursement access

Risks Impacting Financials

• Regulatory restrictions due to adverse event reports
• Competition from newer analgesic formulations
• Market saturation in hospitals
• Reimbursement policy changes

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What Are the Regulatory and Clinical Considerations?

Regulatory Status

• FDA approval (2010) for postoperative pain
• Pending or ongoing trials for other indications
• Increased scrutiny over NSAID safety profiles

Clinical Evidence and Adoption

• Clinical trials show comparable efficacy to IV ketorolac
• Safety profile acceptable within recommended doses
• Shifts toward multimodal pain management support adoption

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Key Takeaways

• SPRIX’s market is driven by its convenience, rapid onset, and NSAID profile.
• Growth relies on expanding indications and increasing hospital adoption.
• Competition from systemic NSAIDs and opioids poses challenges.
• Reimbursement policies favor hospital use but limit outpatient expansion.
• Revenue is forecasted to grow at a compound annual growth rate (CAGR) of roughly 15% from 2022 to 2025, subject to regulatory and clinical developments.

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5 FAQs

1. What factors could hinder SPRIX's growth?
Regulatory restrictions due to safety concerns, competition from other analgesics, and changes in reimbursement policies could limit adoption and sales growth.

2. How does SPRIX compete with IV ketorolac?
SPRIX offers non-invasive nasal delivery with rapid onset, reducing the need for IV access. Its popularity depends on hospital protocols and convenience preferences.

3. Are there new indications for SPRIX?
Trials are investigating uses in outpatient and emergency settings, but regulatory approval for additional indications remains pending.

4. What are the main risks associated with SPRIX?
Adverse events include gastrointestinal bleeding, renal impairment, and bleeding risks, consistent with NSAID class effects.

5. How does reimbursement impact SPRIX’s market penetration?
Reimbursement by payers supports hospital procurement, but outpatient and physician office settings face challenges due to coverage restrictions and cost considerations.

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References

1. Nektar Therapeutics (2022). SPRIX drug approval and clinical data.
2. FDA (2010). Approval letter for SPRIX (ketorolac nasal spray).
3. IQVIA (2022). Pharmaceutical sales data.
4. MarketWatch (2023). Pain management drug market forecast.
5. CDC (2022). Opioid and NSAID use in pain management.