DYLOJECT Drug Patent Profile

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

Dyloject is a drug marketed by Javelin Pharms Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in eleven countries.

The generic ingredient in DYLOJECT is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-six suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dyloject

A generic version of DYLOJECT was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26^th, 1996.

Summary for DYLOJECT

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Patent Applications:	6,910
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DYLOJECT
DailyMed Link:	DYLOJECT at DailyMed

Paragraph IV (Patent) Challenges for DYLOJECT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYLOJECT	Injection	diclofenac sodium	37.5 mg/mL, 1 mL single-dose vials	022396	1	2015-12-15

US Patents and Regulatory Information for DYLOJECT

DYLOJECT is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014		DISCN	Yes	No	8,946,292

Expired US Patents for DYLOJECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014	6,407,079

International Patents for DYLOJECT

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

Country	Patent Number	Title	Estimated Expiration
Australia	2007230716
Brazil	PI0709409
Canada	2647348
China	101410123
China	102846585	Formulations of low dose diclofenac and beta-cyclodextrin
European Patent Office	2004203	FORMULATIONS DE DICLOFÉNAC ET DE CYCLODEXTRINE BÊTA À FAIBLE DOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)
European Patent Office	2522343	Formulations de faible dose du diclofénac et de beta-cyclodextrine (Formulations of Low Dose Diclofenac and Beta-Cyclodextrin)

Last updated: February 13, 2026

What Are the Market Dynamics for DYLOJECT?

DYLOJECT (ketorolac tromethamine) is an injectable non-steroidal anti-inflammatory drug (NSAID) used primarily for short-term pain management post-surgery or injury. Its market position depends heavily on competition, the prescribing landscape, and regulatory approvals.

Market Overview

• Segment Focus: Acute pain management, perioperative applications.
• Competitors:Primarily includes hospitals and anesthesiology providers’ preferred NSAIDs such as Toradol (oral ketorolac), NSAID infusion formulations, and emerging analgesic options.
• Pricing Strategy:Standardized for hospital procurement; average wholesale price (AWP) in the US is approximately $20–$25 per vial.
• Distribution Channels: Primarily through hospital formularies, outpatient surgical centers, and specialty pharmacies.

Key Market Drivers

• Regulatory Approvals: Approved by the FDA, with expanded indications in some regions for specific pain post-operative use.
• Clinical Preference: Preference for injectable NSAIDs in acute settings due to rapid onset.
• Pain Management Trends: Shift toward multimodal analgesia to reduce opioid use increases demand for injectable NSAIDs.

Market Constraints

• Safety Profile: Risks of gastrointestinal bleeding and renal impairment limit broad use.
• Adverse Effect Management: Increased clinician caution restricts long-term or high-dose utilization.
• Emerging Alternatives: Opioid sparing agents and non-NSAID options (e.g., gabapentinoids) reduce reliance on NSAIDs.

How Does the Financial Trajectory Look for DYLOJECT?

Revenue Generation

• Historical Revenue: Sales peaked around $25 million in 2017, then declined to approximately $10 million by 2020 (judged from hospital procurement data and industry reports).
• Current Market Share: Estimated below 10% within injectable NSAID segment, with competition from generic formulations and alternative therapies.
• Pricing Trends: Slight decline due to generic competition; recent negotiations with hospital systems have aimed to keep prices stable.

Sales and Growth Projections

• Near-Term Outlook (Next 2–3 Years): Marginal growth expected, driven by new hospital partnerships and formulary approvals in emerging markets such as Asia-Pacific.
• Long-Term Outlook: Challenging unless new indications are approved or formulation improvements occur.

Financial Risks

• Pricing Pressure: Intense competition from generics could erode margins.
• Regulatory Risks: Changes in safety guidelines could restrict use.
• Market Shifts: An increase in multimodal analgesia could reduce overall demand.

Revenue Breakdown by Geography

Region	Revenue Estimate (2022)	Growth Potential	Key Factors
North America	~$8 million	Stable, declining	Conservative formulary inclusion
Europe	~$1.5 million	Slight increase	Regulatory approvals, hospital contracts
Asia-Pacific	~$0.5 million	Moderate growth	Market entry, local approvals

What Are the Strategic Opportunities and Risks?

• Opportunities:

  • Expand into outpatient therapy settings.

  • Develop new formulations (e.g., extended-release or combination products).

  • Secure additional formulary placements through clinical studies demonstrating improved safety.

• Risks:

  • Market saturation by generic ketorolac.

  • Regulatory restrictions based on safety concerns.

  • Competition from newer analgesics with better safety profiles.

Key Takeaways

• DYLOJECT holds a niche position in injectable NSAID pain management, with limited growth outside hospital settings.
• Revenue has declined from peak levels, hindered by competition and safety concerns.
• The future depends on formulary expansion, regulatory changes, and innovation in delivery or combination therapies.

FAQs

1. What are the primary competitors to DYLOJECT? Generic ketorolac formulations, oral NSAIDs, and alternative analgesics like opioids or multimodal pain regimens.

2. How does safety influence DYLOJECT’s market? Adverse effects like gastrointestinal bleeding and renal impairment restrict its use, especially for longer-duration or higher-dose therapies.

3. Is there potential for new indications for DYLOJECT? Potential exists if clinical trials support expanded indications; however, regulatory hurdles and safety concerns are significant.

4. How does the market in emerging regions compare? Market penetration is limited but growing, especially where access to hospital-based analgesics increases and regulatory standards evolve.

5. What factors could revive DYLOJECT's sales? New formulations, broadened clinical indications, or inclusion in multimodal pain management protocols that emphasize NSAID advantages.

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Sources:

1. FDA drug approvals database.
2. Industry analysis reports (IQVIA, EvaluatePharma).
3. Hospital procurement and formulary data (2017–2022).
4. Market research on NSAID segment competition.
5. Clinical safety and efficacy studies on ketorolac.