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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
McKinsey
Citi
Merck
Chinese Patent Office
Deloitte
UBS
Medtronic
Accenture

Generated: January 20, 2018

DrugPatentWatch Database Preview

DILAUDID Drug Profile

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When do Dilaudid patents expire, and what generic 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-seven suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Drug patent expirations by year for DILAUDID
Pharmacology for DILAUDID
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for DILAUDID

US Patents and Regulatory Information 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;INJECTION 019034-003 Apr 30, 2009 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-001 Dec 7, 1992 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Rhodes Pharms DILAUDID hydromorphone hydrochloride SOLUTION;ORAL 019891-001 Dec 7, 1992 AA RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-002 Nov 9, 2007 AB RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-003 Nov 9, 2007 AB RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Paragraph IV (Patent) Challenges for DILAUDID
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 2 mg/mL ➤ Subscribe 6/22/2011
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 11/4/2011
➤ Subscribe Oral Solution 5 mg/5mL ➤ Subscribe 2/25/2011
➤ Subscribe Tablets 2 mg, 4 mg, and 8 mg ➤ Subscribe 8/5/2013

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

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International Patents for DILAUDID

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
Johnson and Johnson
Cipla
US Army
Moodys
Fish and Richardson
Novartis
Merck

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