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Hydromorphone hydrochloride - Generic Drug Details

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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, Purdue Pharm Prods, Lannett, Purdue Pharma Lp, Barr, Actavis Labs Fl Inc, Roxane, Mallinckrodt, Paddock Llc, 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.

This ingredient has seventeen patent family members in nine countries.

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

Summary for Generic Name: hydromorphone hydrochloride

Tradenames:5
Patents:1
Applicants:17
NDAs:23
Drug Master File Entries: see list13
Suppliers / Packaging: see list26
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: hydromorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL074597-003May 29, 2009RXNo► subscribe► subscribe
Nesher Pharms
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL077311-003Nov 9, 2005DISCNNo► subscribe► subscribe
Purdue Pharm Prods
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-005Apr 30, 2009RXYes6,589,960► subscribeYY ► 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
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 20105,702,725► subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-004Sep 24, 20045,958,452► subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-004Sep 24, 20046,706,281► 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
Austria402937► subscribe
Japan4886953► subscribe
European Patent Office2003134► 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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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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