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Serving leading biopharmaceutical companies globally:

Deloitte
Express Scripts
Fish and Richardson
Julphar
Medtronic
Fuji
AstraZeneca
Federal Trade Commission
Farmers Insurance
Argus Health

Generated: November 18, 2017

DrugPatentWatch Database Preview

DYLOJECT Drug Profile

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What is the patent landscape for Dyloject, and what generic Dyloject alternatives are available?

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

This drug has twenty-two 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. Eighty-nine suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
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;INTRAVENOUS022396-001Dec 23, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Javelin Pharms Inc
DYLOJECT
diclofenac sodium
SOLUTION;INTRAVENOUS022396-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Javelin Pharms Inc
DYLOJECT
diclofenac sodium
SOLUTION;INTRAVENOUS022396-001Dec 23, 2014RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for DYLOJECT

Drugname Dosage Strength RLD Submissiondate
diclofenac sodiumInjection37.5 mg/mL, 1 mL single-dose vialsDyloject12/15/2015

Non-Orange Book Patents for Tradename: DYLOJECT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,580,954Formulations of low dose diclofenac and beta-cyclodextrin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: DYLOJECT

Country Document Number Estimated Expiration
Japan6157305► Subscribe
South Korea20160033796► Subscribe
Japan5823093► Subscribe
China102846585► Subscribe
BrazilPI0709409► Subscribe
Mexico2008012495► Subscribe
European Patent Office2004203► Subscribe
European Patent Office2522343► Subscribe
South Africa200808115► Subscribe
Japan2014005309► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
McKesson
Chubb
Merck
Julphar
Cerilliant
Teva
Dow
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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