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Last Updated: May 27, 2024

DILAUDID Drug Patent Profile


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Which patents cover Dilaudid, 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 are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-two patent family members in twelve countries.

The generic ingredient in DILAUDID is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Drug patent expirations by year for DILAUDID
Drug Prices for DILAUDID

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Drug Sales Revenue Trends for DILAUDID

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Recent Clinical Trials for DILAUDID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MiamiPhase 2
The Cleveland ClinicN/A
Hennepin Healthcare Research InstitutePhase 4

See all DILAUDID clinical trials

Pharmacology for DILAUDID
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for DILAUDID
Paragraph IV (Patent) Challenges for DILAUDID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DILAUDID Tablets hydromorphone hydrochloride 2 mg, 4 mg, and 8 mg 019892 1 2013-08-05
DILAUDID Oral Solution hydromorphone hydrochloride 5 mg/5mL 019891 1 2011-02-25

US Patents and Regulatory Information for DILAUDID

DILAUDID is protected by two US patents.

Patents protecting DILAUDID

Packaging system for oxygen-sensitive drugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Drug container
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 019034-006 Jan 16, 2020 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-007 Feb 10, 2017 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-003 Nov 9, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DILAUDID

International Patents for DILAUDID

See the table below for patents covering DILAUDID around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2338891 ⤷  Sign Up
Japan 2012510330 ⤷  Sign Up
European Patent Office 2968729 SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) ⤷  Sign Up
Spain 2693123 ⤷  Sign Up
European Patent Office 2376147 RÉCIPIENT DE MÉDICAMENT AMÉLIORÉ (IMPROVED DRUG CONTAINER) ⤷  Sign Up
Japan 4886953 ⤷  Sign Up
China 204798475 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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