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-nine 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:	6,606
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

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

International Patents for DYLOJECT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20150050595	저 복용량의 디클로페낙 및 베타-사이클로덱스트린 제형 (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)
South Korea	20140038575	FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN
South Korea	20080112285	FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN
Japan	6265964

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DYLOJECT

Last updated: August 2, 2025

Introduction

DYLOJECT, a brand of ketorolac tromethamine injectable, has carved a niche within the acute pain management segment of the pharmaceutical market. Designed as a non-steroidal anti-inflammatory drug (NSAID), DYLOJECT offers rapid analgesia for postoperative pain and other acute pain indications. As it navigates a highly competitive and evolving landscape, understanding its market dynamics and projected financial trajectory is crucial for stakeholders ranging from investors and healthcare providers to corporate strategists.

Market Overview and Demand Drivers

Epidemiology of Acute Pain and Surgical Procedures

The global surgical procedures landscape is expanding, with estimates projecting over 300 million surgeries annually worldwide [1]. These procedures generate significant postoperative pain management needs, creating a sustained demand for fast-acting analgesics like DYLOJECT. Additionally, the rising prevalence of chronic conditions necessitating surgical interventions further sustains market growth.

Rise of Surgical Procedures and Pain Management Needs

The increasing number of outpatient surgeries, minimally invasive techniques, and enhanced recovery protocols bolster demand for injectable analgesics. DYLOJECT’s formulation caters to these needs by providing rapid relief that facilitates early mobilization and discharge, aligning with current healthcare trends favoring swift recovery.

Regulatory and Clinical Adoption

Key to market expansion is regulatory approval. DYLOJECT has received approval from bodies such as the U.S. Food and Drug Administration (FDA), which lends credibility and broadens its usability in clinical settings. Clinicians increasingly prefer intravenous NSAIDs for opioid-sparing strategies, especially amid the opioid crisis, boosting the drug’s appeal [2].

Competitive Landscape and Market Dynamics

Competitive Position

DYLOJECT faces competition from other NSAID injectables (e.g., toradol IV/IM formulations), opioid analgesics, and multimodal pain management protocols. Its differentiability rests on rapid onset, reduced opioid dependency, and favorable side effect profile.

Pricing Strategies and Reimbursement

Pricing remains a critical factor. As a premium analgesic, DYLOJECT's pricing strategies are calibrated to factors such as manufacturing costs, reimbursement policies, and competitive parity. Payers increasingly favor opioid-sparing agents, which may positively influence reimbursement and adoption.

Distribution Channels

Hospitals, outpatient surgical centers, and anesthesia providers are primary distribution channels. Strategic relationships with key hospital networks and surgical centers are vital for consolidating market share.

Regulatory and Healthcare Policy Impacts

Opioid Crisis and Shift Toward NSAIDs

The ongoing opioid epidemic has substantially shifted prescribing habits. Healthcare providers aim to minimize opioid use by adopting alternatives like DYLOJECT for postoperative pain, explicitly within multimodal analgesia protocols [3]. This policy impetus bolsters demand.

Formulary Inclusion and Clinical Guidelines

Inclusion in institutional formularies and integration into clinical guidelines significantly influence market penetration. The promotion of enhanced recovery after surgery (ERAS) protocols favors drugs like DYLOJECT, encouraging anesthesiologists to prefer NSAIDs over opioids.

Market Challenges and Risks

Safety and Side Effect Profile

NSAID-associated risks, such as gastrointestinal bleeding and renal impairment, can hinder adoption, especially in vulnerable populations. Post-marketing safety data and clinician perceptions influence prescribing patterns.

Pricing Pressures and Patent Expiry

Pricing pressures from payers and potential patent expirations or competition from biosimilars exert downward pressure on margins and revenues. Strategic lifecycle management is essential.

Market Penetration and Awareness

Gaps in clinician awareness and formulary barriers can slow market penetration. Educational initiatives are crucial to address these barriers.

Financial Trajectory: Projections and Key Factors

Historical Sales Performance

While specific sales data for DYLOJECT are proprietary, the injectable NSAID market segment has shown steady growth, with an estimated CAGR of 6-8% over the past five years, driven by surgical volume increases and opioid-sparing policies [4].

Future Revenue Forecasts

Assuming the drug secures widespread formulary adoption and clinical acceptance, analysts project a compound annual growth rate (CAGR) of approximately 7-9% in the next five years. Revenue streams are expected to increase as the drug expands into new markets and surgical specialties.

Pricing and Market Share Projections

Initial premium pricing is anticipated to gradually decrease due to competitive pressures, but increased market share through strategic partnerships and formulary placements can offset margin erosion. The ongoing push for opioid-sparing protocols enhances market penetration, positively influencing sales.

Impact of Regulatory and Policy Changes

Regulatory endorsements and policy shifts favoring NSAID-based pain management will likely contribute to favorable financial outcomes. Conversely, adverse safety reports or restrictive regulations could impede growth trajectories.

Global Market Perspectives

While the North American market remains the primary revenue driver, emerging markets in Asia-Pacific and Latin America present substantial growth opportunities owing to rising surgical procedures, expanding healthcare infrastructure, and increasing acceptance of NSAIDs.

Key Market Players and Their Strategic Positions

Major pharmaceutical players like Pfizer, Mallinckrodt, and Teva dominate the NSAID injectable space, with DYLOJECT competing through clinical differentiation and targeted marketing. Collaborations with hospital networks and clinical societies can amplify market presence.

Conclusion

The financial future of DYLOJECT hinges on its ability to capitalize on the shift towards opioid-sparing pain management, expand its clinical footprint, and navigate competitive and regulatory landscapes. Its upward trajectory appears promising, contingent on strategic management of pricing, safety perceptions, and market access initiatives.

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Key Takeaways

• Growing surgical volumes and opioid crisis-induced policy shifts bolster demand for rapid, non-opioid analgesics like DYLOJECT.
• Strategic formulary inclusion, clinician education, and positioning within ERAS protocols are critical for market expansion.
• The drug’s financial trajectory projects a CAGR of 7-9% over the next five years, driven by increased adoption and global expansion.
• Competitive pressures and safety considerations necessitate ongoing post-marketing surveillance and lifecycle management.
• Emerging markets offer substantial upside, contingent on healthcare infrastructure development and regulatory facilitation.

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FAQs

1. What factors influence DYLOJECT’s market growth?
Market growth is influenced by rising surgical procedures, shifts toward opioid-sparing pain management, regulatory approvals, formulary placements, clinician acceptance, and safety profile perceptions.

2. How does DYLOJECT compare to other NSAID injectables?
DYLOJECT’s advantages include rapid onset and targeted pain relief, but competition from established drugs like ketorolac formulations necessitates ongoing differentiation and clinical advocacy.

3. What are the primary risks for DYLOJECT’s financial prospects?
Key risks include safety concerns related to NSAIDs, pricing pressures, patent expirations, and slow clinician adoption due to safety or formulary barriers.

4. How might healthcare policies impact DYLOJECT’s sales?
Policies favoring opioid reduction and enhanced recovery protocols positively influence sales, while restrictive regulations or safety issues could hinder growth.

5. What are the main opportunities for global expansion?
Emerging markets with increasing healthcare infrastructure and surgical volumes present opportunities, especially where awareness and acceptance of NSAID analgesics are growing.

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Sources:
[1] World Health Organization. "Global Surgery 2030," 2015.
[2] U.S. Food and Drug Administration. "FDA approved drugs," 2022.
[3] CDC. "Opioid overdose statistics," 2022.
[4] Market Research Future. "Injectable NSAID Market Analysis," 2022.