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Generated: December 17, 2017

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HYDROMORPHONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for hydromorphone hydrochloride and what is the scope of hydromorphone hydrochloride freedom to operate?

Hydromorphone hydrochloride
is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Fresenius Kabi Usa, Akorn, Barr, Hospira, Hospira Inc, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, West-ward Pharms Int, Mallinckrodt Inc, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett, Mallinckrodt, and Nesher Pharms, and is included in twenty-four 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-six suppliers are listed for this compound.

Pharmacology for HYDROMORPHONE HYDROCHLORIDE

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for HYDROMORPHONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
MallinckrodtHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET;ORAL076855-003Sep 19, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Nesher PharmsHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET;ORAL077311-003Nov 9, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
LannettHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET;ORAL078439-002Dec 9, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Rhodes PharmsDILAUDIDhydromorphone hydrochlorideTABLET;ORAL019892-002Nov 9, 2007ABRXYesNo► Subscribe► SubscribeYY► Subscribe
OsmoticaHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL205629-004Jul 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
MallinckrodtHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET;ORAL076855-002Sep 19, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
OsmoticaHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL205629-002Jul 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Rhodes PharmsDILAUDIDhydromorphone hydrochlorideSOLUTION;ORAL019891-001Dec 7, 1992AARXYesYes► Subscribe► SubscribeYY► Subscribe
Paddock LlcHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204278-002Apr 6, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Elite LabsHYDROMORPHONE HYDROCHLORIDEhydromorphone hydrochlorideTABLET;ORAL076723-001Oct 18, 2005ABRXNoNo► 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 LpPALLADONEhydromorphone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma LpPALLADONEhydromorphone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma LpPALLADONEhydromorphone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021044-001Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma LpPALLADONEhydromorphone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Purdue Pharma LpPALLADONEhydromorphone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Purdue Pharma LpPALLADONEhydromorphone hydrochlorideCAPSULE, 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
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:

Chinese Patent Office
Express Scripts
Julphar
Colorcon
Cerilliant
Cantor Fitzgerald
Medtronic
Novartis
Accenture
Argus Health

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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