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Generated: September 23, 2017

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Hydromorphone hydrochloride - Generic Drug Details

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What are the generic sources for hydromorphone hydrochloride and what is the scope of hydromorphone hydrochloride patent protection?

Hydromorphone hydrochloride
is the generic ingredient in five branded drugs marketed by Hospira Inc, Nesher Pharms, Aurolife Pharma Llc, Watson Labs, Mallinckrodt Inc, Elite Labs, Akorn, Osmotica, Fresenius Kabi Usa, Lannett, Purdue Pharma Lp, Barr, Actavis Labs Fl Inc, West-ward Pharms Int, Mallinckrodt, Paddock Llc, Rhodes Pharms, and Hospira, and is included in twenty-three NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydromorphone hydrochloride has seventeen patent family members in nine countries.

There are fourteen drug master file entries for hydromorphone hydrochloride. Twenty-eight suppliers are listed for this compound.

Summary for Generic Name: hydromorphone hydrochloride

Tradenames:5
Patents:1
Applicants:18
NDAs:23
Drug Master File Entries: see list14
Suppliers / Packagers: see list28
Bulk Api Vendors: see list18
Clinical Trials: see list2,446
Patent Applications: see list6,022
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:hydromorphone hydrochloride at DailyMed

Pharmacology for Ingredient: hydromorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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
Osmotica
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205629-004Jul 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
INJECTABLE;INJECTION200403-002Dec 1, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Mallinckrodt
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL076855-003Sep 19, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-002Aug 4, 1994DISCNNoNo► Subscribe► SubscribeY ► Subscribe
West-ward Pharms Int
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL074597-001Jul 29, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Osmotica
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205629-001Jul 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Lannett
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL077471-002Dec 9, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL076855-002Sep 19, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hydromorphone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-001Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-002Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-001Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-004Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-002Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-004Sep 24, 2004► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-002Sep 24, 2004► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: hydromorphone hydrochloride

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 Ingredient: hydromorphone hydrochloride

Country Document Number Estimated Expiration
Japan2003513980► Subscribe
Austria500257► Subscribe
Canada2674424► Subscribe
Spain2359657► Subscribe
Germany60039711► Subscribe
Germany60045695► Subscribe
Australia1595701► Subscribe
Canada2389193► Subscribe
European Patent Office2003134► Subscribe
MexicoPA02004678► 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 500+ biopharmaceutical companies globally:

McKinsey
Cerilliant
Julphar
Moodys
US Army
Boehringer Ingelheim
Medtronic
Cipla
Merck
McKesson

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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