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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Deloitte
Medtronic
Johnson and Johnson
Fuji
Teva
Novartis
Baxter
Daiichi Sankyo
Mallinckrodt

Generated: November 20, 2017

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DILAUDID Drug Profile

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

Dilaudid is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. There is one patent protecting this drug and four Paragraph IV challenges.

This drug has seventeen patent family members in nine countries.

The generic ingredient in DILAUDID 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.

Pharmacology for DILAUDID

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for DILAUDID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-003Apr 30, 2009APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Rhodes Pharms
DILAUDID
hydromorphone hydrochloride
TABLET;ORAL019892-001Dec 7, 1992ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Rhodes Pharms
DILAUDID
hydromorphone hydrochloride
SOLUTION;ORAL019891-001Dec 7, 1992AARXYesYes► Subscribe► SubscribeYY ► Subscribe
Fresenius Kabi Usa
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-001Jan 11, 1984APRXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-004Apr 30, 2009APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Fresenius Kabi Usa
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-005Apr 30, 2009APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Rhodes Pharms
DILAUDID
hydromorphone hydrochloride
TABLET;ORAL019892-002Nov 9, 2007ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Rhodes Pharms
DILAUDID
hydromorphone hydrochloride
TABLET;ORAL019892-003Nov 9, 2007ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Fresenius Kabi Usa
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-002Aug 4, 1994DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for DILAUDID

Drugname Dosage Strength RLD Submissiondate
hydromorphone hydrochlorideInjection2 mg/mLDilaudid6/22/2011
hydromorphone hydrochlorideInjection10 mg/mLDilaudid-HP11/4/2011
hydromorphone hydrochlorideOral Solution5 mg/5mLDilaudid2/25/2011
hydromorphone hydrochlorideTablets2 mg, 4 mg, and 8 mgDilaudid8/5/2013

Non-Orange Book Patents for Tradename: DILAUDID

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

Country Document Number Estimated Expiration
MexicoPA02004678► Subscribe
Germany60039711► Subscribe
Japan4886953► Subscribe
Spain2309001► Subscribe
Austria500257► Subscribe
Spain2359657► Subscribe
Austria402937► Subscribe
European Patent Office2338891► Subscribe
Australia1595701► Subscribe
Germany60045695► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Baxter
Healthtrust
Dow
Fish and Richardson
Farmers Insurance
Accenture
Johnson and Johnson
Novartis

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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