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Serving leading biopharmaceutical companies globally:

Moodys
Accenture
Harvard Business School
McKesson
Teva
Fuji
Boehringer Ingelheim
Cantor Fitzgerald
Fish and Richardson
Queensland Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

DILAUDID-HP Drug Profile

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When do Dilaudid-hp patents expire, and when can generic versions of Dilaudid-hp launch?

Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seventeen patent family members in nine countries.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Drug patent expirations by year for DILAUDID-HP

Pharmacology for DILAUDID-HP

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for DILAUDID-HP

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi UsaDILAUDID-HPhydromorphone hydrochlorideINJECTABLE;INJECTION019034-001Jan 11, 1984APRXYesYes► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaDILAUDID-HPhydromorphone hydrochlorideINJECTABLE;INJECTION019034-002Aug 4, 1994DISCNNoNo► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for DILAUDID-HP

Drugname Dosage Strength RLD Submissiondate
hydromorphone hydrochlorideInjection10 mg/mLDilaudid-HP11/4/2011

Non-Orange Book Patents for Tradename: DILAUDID-HP

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
6,512,117 Hydromorphone and hydrocodone compositions and methods for their synthesis► 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: DILAUDID-HP

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0134608► Subscribe
Japan2003513980► Subscribe
MexicoPA02004678► Subscribe
Germany60045695► Subscribe
European Patent Office2338891► Subscribe
Spain2359657► Subscribe
Canada2854796► Subscribe
Canada2674424► Subscribe
Austria500257► Subscribe
Canada2389193► 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:

Harvard Business School
Dow
Novartis
Daiichi Sankyo
Queensland Health
Cantor Fitzgerald
QuintilesIMS
Boehringer Ingelheim
Fish and Richardson
Chinese Patent Office

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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