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-seven 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:	121
Patent Applications:	4,203
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
Japan	2016040327	低投与量のジクロフェナク及びβ−シクロデキストリンの配合物 (FORMULATION OF LOW DOSE DICLOFENAC AND &bgr;-CYCLODEXTRIN)
Japan	2014005309	FORMULATION OF LOW DOSE DICLOFENAC AND &bgr;-CYCLODEXTRIN
Canada	2647348	FORMULATIONS DE DICLOFENAC ET DE CYCLODEXTRINE BETA A FAIBLEDOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)

DYLOJECT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dyloject

Introduction

Dyloject, a proprietary formulation of diclofenac sodium developed by Javelin Pharmaceuticals, has been a significant player in the nonsteroidal anti-inflammatory drug (NSAID) market, particularly for managing postoperative pain. Here, we delve into the market dynamics and financial trajectory of Dyloject.

Clinical Efficacy and Safety

Dyloject has demonstrated strong clinical efficacy in several Phase 3 trials. These studies, conducted in patients undergoing abdominal and orthopedic surgeries, showed that Dyloject met primary and secondary analgesic efficacy endpoints, providing superior pain relief compared to placebo and other NSAIDs like ketorolac[1][2].

The drug's safety profile has also been favorable, with adverse events similar across all treatment groups and significantly less thrombophlebitis (vein irritation) compared to other IV diclofenac formulations and ketorolac[1].

Market Approval and Expansion

Dyloject was approved for marketing in the United Kingdom in October 2007 and subsequently entered hospital formularies in early 2008. The drug's approval was based on its superior efficacy and safety compared to the existing IV formulation of diclofenac in the UK[2].

To expand its market reach, Javelin Pharmaceuticals entered into a License and Commercialization Agreement with Therabel Pharma N.V. in January 2009. This agreement granted Therabel exclusive rights to commercialize Dyloject in the UK, European Union, and other countries outside the US, along with assuming all commercialization, regulatory, and manufacturing responsibilities[2].

Financial Performance

The financial performance of Dyloject has been marked by significant milestones. In the UK, Dyloject generated approximately $1.1 million in revenue during the 2008 fiscal year. The licensing agreement with Therabel Pharma N.V. yielded an upfront payment of $7.0 million and an additional $5.0 million for the sale of existing inventory. The agreement also provided potential earnings of up to $59.5 million if certain sales and regulatory milestones were met, along with a double-digit royalty on future net sales[2].

Market Size and Growth

The global diclofenac market, within which Dyloject operates, is projected to grow significantly. By 2033, the market is expected to be worth around USD 6.4 billion, growing at a CAGR of 4.3% from 2023 to 2033[3].

Regional Dominance

The Asia Pacific region dominates the diclofenac market, holding a 35.5% share valued at USD 1.5 billion. This regional dominance is driven by the high prevalence of chronic pain conditions and the growing geriatric population[3].

Distribution Channels

Retail pharmacies are the primary distribution channels for diclofenac products, including Dyloject, with a significant market share. This highlights the importance of accessible and convenient retail outlets for these medications[3].

Innovations and Competitive Landscape

Dyloject's proprietary solubilizing agent makes it less irritating to veins compared to other IV diclofenac formulations, which is a significant competitive advantage. The drug's ready-to-use formulation for immediate IV bolus administration also enhances its clinical attributes and pharmacoeconomic benefits[1].

Novel Formulation Techniques

The development of novel formulation techniques, such as extended-release and transdermal formulations, offers growth opportunities for Dyloject. These innovations can enhance the drug's efficacy, improve bioavailability, and reduce the frequency of dosing, thereby improving patient compliance and mitigating adverse effects[3].

Generic Competition

The diclofenac market is influenced by the increasing production of generic drugs. As patents expire, generic versions become more prevalent, making treatment more affordable but also intensifying market competition and potentially driving down prices. This trend affects the profit margins of original manufacturers like Javelin Pharmaceuticals[3].

Regulatory Considerations

The U.S. development program for Dyloject required additional studies due to the absence of an approved injectable diclofenac product in the US market. Despite these regulatory hurdles, Dyloject has demonstrated its safety and efficacy in various clinical trials, including a Phase 2b US study that showed superior onset of pain relief compared to ketorolac[2][4].

Key Takeaways

• Clinical Efficacy: Dyloject has shown superior pain relief in postoperative patients, meeting primary and secondary efficacy endpoints in Phase 3 trials.
• Market Approval: Approved in the UK and expanding into other European countries through a licensing agreement with Therabel Pharma N.V.
• Financial Performance: Generated significant revenue in the UK and received substantial upfront and milestone payments from the licensing agreement.
• Market Growth: Part of a growing global diclofenac market projected to reach USD 6.4 billion by 2033.
• Competitive Advantage: Proprietary solubilizing agent and ready-to-use formulation differentiate Dyloject from other IV diclofenac products.
• Regulatory Landscape: Additional studies required for US approval, but strong safety and efficacy data support its potential.

FAQs

What is Dyloject and how does it differ from other NSAIDs?

Dyloject is a proprietary formulation of diclofenac sodium developed by Javelin Pharmaceuticals. It differs from other NSAIDs due to its proprietary solubilizing agent, which makes it less irritating to veins, and its ready-to-use formulation for immediate IV bolus administration.

What are the key clinical findings for Dyloject?

Dyloject has demonstrated superior pain relief in postoperative patients, meeting primary and secondary efficacy endpoints in Phase 3 trials. It has shown a faster onset of pain relief compared to ketorolac and fewer adverse events, particularly less thrombophlebitis[1][2].

How has Dyloject performed financially?

Dyloject generated approximately $1.1 million in revenue in the UK during the 2008 fiscal year. The licensing agreement with Therabel Pharma N.V. yielded an upfront payment of $7.0 million and additional payments for inventory and potential milestone earnings[2].

What are the growth prospects for the diclofenac market?

The global diclofenac market is projected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, with a CAGR of 4.3%. This growth is driven by the prevalence of chronic pain conditions, advancements in drug formulation technologies, and the growing geriatric population[3].

How does Dyloject compete in a market with increasing generic competition?

Dyloject's proprietary formulation and clinical advantages differentiate it from generic versions. However, the increasing production of generic diclofenac products intensifies market competition and could impact profit margins for original manufacturers like Javelin Pharmaceuticals[3].

What regulatory challenges has Dyloject faced?

Dyloject required additional studies for US approval due to the absence of an approved injectable diclofenac product in the US market. Despite these challenges, Dyloject has demonstrated strong safety and efficacy data in various clinical trials[2][4].

Sources

1. Javelin Pharmaceuticals - FDA Recommends Additional Study for Pain Drug[1].
2. Javelin Pharmaceuticals, Inc. - Annual Report[2].
3. Market.us - Diclofenac Market Size, Share, Growth[3].
4. FDA - Dyloject Labeling and Safety Information[4].