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

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

International Patents for SPRIX

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05194215	THERAPEUTIC COMPOSITION FOR NARIAL ADMINISTRATION CONTAINING 5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIDINE- 1-CARBOXYLIC ACID
Denmark	0524587
Greece	3019012
European Patent Office	0524587	Compositions thérapeutiques pour l'administration intranasale contenant ketorolac R. (Therapeutic compositions for intranasal administration which include ketorolac TM.)
Austria	130758
Spain	2082288
Italy	MI912024

Supplementary Protection Certificates for SPRIX

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	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. 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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; 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	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	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

Investment Scenario and Fundamentals Analysis for SPRIX (ketorolac nasal spray)

Last updated: February 21, 2026

What is SPRIX and what is its market positioning?

SPRIX (ketorolac nasal spray) is a nonsteroidal anti-inflammatory drug (NSAID) approved for managing moderate to severe pain in adults. It offers an alternative to traditional pain management options, such as opioids and oral NSAIDs. Approval was granted by the FDA in September 2019, with a primary focus on post-operative pain management.

The drug is marketed by Horizant, Inc., and distributed through pharmacies for inpatient and outpatient settings. Its nasal delivery system aims to provide rapid onset of action, addressing demand for fast-acting pain relief without opioids.

What does the clinical and regulatory landscape look like?

FDA Approval and Usage

• Approved for mild to moderate pain following surgery.
• Lacks approval for chronic pain or other indications.
• Post-approval studies focus on expanding indications and demonstrating comparative advantages over existing NSAIDs or opioids.

Market Approvals in Other Jurisdictions

• Not yet available outside the U.S.
• Pending regulatory applications in Europe and Asia.

Competitive Landscape

• Competes with oral NSAIDs, opioids, and other locally acting analgesics.
• No direct nasal spray equivalents for NSAID-based pain management.

What are the key commercial and operational fundamentals?

Market Size and Penetration

• Estimated U.S. post-surgical pain market valued at approximately $3.5 billion annually (IQVIA, 2021).
• Direct market share remains under 5% due to limited clinician awareness and reimbursement hurdles.
• Growth potential tied to adoption in outpatient surgeries and enhanced marketing strategies.

Pricing and Reimbursement

• Retail price per dose: around $50, according to current pricing data.
• Reimbursement policies vary; insurance coverage is limited but expected to improve with expanding indications.
• Cost-effectiveness considered in comparison with opioids and IV NSAIDs.

Manufacturing and Supply Chain

• Formulated as a nasal spray with proprietary delivery technology.
• Manufacturing capacity scalable within existing facilities.
• Supply chain risks include raw material availability and distribution logistics.

Regulatory and Patent Outlook

• Patent status extends until 2030, with additional formulations under patent pending.
• Pending FDA label expansion applications.
• Regulatory barriers are moderate, with potential delays in indication expansion.

What are the investment risks?

• Regulatory approval for broader indications remains pending.
• Competition from emerging analgesic therapies, including novel non-opioid options.
• Reimbursement barriers may limit uptake.
• Market penetration comparatively slow due to clinician familiarity with oral NSAIDs.

What are the growth drivers?

• Increasing demand for non-opioid pain management options.
• Rising procedural volumes, particularly in outpatient surgery.
• Potential for expanded indications, such as acute migraine or dental pain.
• Strategic partnerships to increase awareness and reach.

Financial outlook and valuation considerations

Item	Data/Estimates
Estimated peak sales	$300-500 million (potential conditional on indication expansion)
Current sales (2022)	<$10 million; primarily early adopters
R&D and marketing expenses	Approximately $50 million annually
Investment horizon	3-5 years
Discount rate	10%
Valuation multiple	3-5x peak sales

Given the modest current revenue and high fragmentation in the pain management sector, valuation depends heavily on success in clinical trials, regulatory approval, and market adoption.

What is the strategic outlook?

• Short term: Focus on clinical demonstration, regulatory approval of new indications, and marketing expansion.
• Long term: Potential to carve out niche within outpatient pain management, especially if indications expand.

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Key Takeaways

• SPRIX offers a fast-acting, non-opioid alternative for post-surgical pain with limited current market penetration.
• Regulatory and reimbursement hurdles are primary risks; success hinges on expanded indications.
• Competitive landscape is fragmented; market growth driven by procedural volume increases and clinician preferences.
• Valuation remains speculative until clinical and regulatory milestones are achieved.

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FAQs

1. How does SPRIX compare to oral NSAIDs in pain management?
SPRIX provides rapid onset of relief due to nasal delivery, whereas oral NSAIDs have delayed absorption. It minimizes systemic gastrointestinal risks associated with oral NSAIDs.

2. What are the main barriers to market growth?
Limited clinician awareness, reimbursement policy hurdles, and slow indication expansion inhibit rapid adoption.

3. Are there any significant patent protections for SPRIX?
Yes, patents extend until 2030, with pending applications for new formulations.

4. What is the competitive advantage of SPRIX?
Fast onset, non-opioid profile, and targeted delivery system. However, its market share remains limited due to competition and awareness issues.

5. What indications could expand the commercial potential?
Acute migraine, dental pain, and other minor procedural pain are potential areas for growth.

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References

[1] IQVIA. (2021). U.S. Pain Management Market Analysis.
[2] FDA. (2019). Approval Letter for SPRIX (ketorolac nasal spray).
[3] Horizant Inc. Corporate filings and clinical trial registries.