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Serving leading biopharmaceutical companies globally:

Chubb
Healthtrust
Johnson and Johnson
Accenture
Chinese Patent Office
Federal Trade Commission
Fish and Richardson
Julphar
McKesson
UBS

Generated: February 23, 2018

DrugPatentWatch Database Preview

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 Purdue Pharma Lp, Fresenius Kabi Usa, Akorn, Barr, Hospira, Hospira Inc, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, West-ward Pharms Int, Specgx Llc, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett, and Nesher Pharms, and is included in twenty-five 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.
Summary for hydromorphone hydrochloride
Pharmacology for hydromorphone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for hydromorphone hydrochloride

US Patents and Regulatory Information 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
Osmotica HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-002 Jul 7, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 074597-001 Jul 29, 1998 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-003 Apr 30, 2009 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Aurolife Pharma Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814-002 May 13, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144-004 Jun 30, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ascent Pharms Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 210506-003 Jan 17, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nesher Pharms HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077311-003 Nov 9, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-002 Nov 9, 2007 AB RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Lannett HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077471-002 Dec 9, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Elite Labs HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076723-001 Oct 18, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for hydromorphone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-004 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-004 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for hydromorphone hydrochloride

Country Document Number Estimated Expiration
Austria 500257 ➤ Sign Up
Canada 2854796 ➤ Sign Up
Canada 2389193 ➤ Sign Up
Mexico PA02004678 ➤ Sign Up
Canada 2674424 ➤ Sign Up
Spain 2359657 ➤ Sign Up
European Patent Office 2003134 ➤ Sign Up
Australia 1595701 ➤ Sign Up
Japan 4886953 ➤ Sign Up
Germany 60039711 ➤ Sign Up
Country Document Number Estimated Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Colorcon
AstraZeneca
Farmers Insurance
McKesson
Daiichi Sankyo
Teva
Medtronic
Baxter

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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