You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

DILAUDID-HP Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Dilaudid-hp, and what generic alternatives are available?

Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are two patents protecting this drug and four Paragraph IV challenges.

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

The generic ingredient in DILAUDID-HP 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-HP
Recent Clinical Trials for DILAUDID-HP

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-HP clinical trials

Pharmacology for DILAUDID-HP
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for DILAUDID-HP
Paragraph IV (Patent) Challenges for DILAUDID-HP
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DILAUDID-HP Injection hydromorphone hydrochloride 0.2 mg/mL 019034 1 2023-12-19
DILAUDID-HP Injection hydromorphone hydrochloride 0.5 mg/0.5 mL 019034 1 2022-12-13
DILAUDID-HP Injection hydromorphone hydrochloride 10 mg/mL 019034 1 2011-11-04
DILAUDID-HP Injection hydromorphone hydrochloride 2 mg/mL 019034 1 2011-06-22

US Patents and Regulatory Information for DILAUDID-HP

DILAUDID-HP is protected by two US patents.

Patents protecting DILAUDID-HP

Packaging system for oxygen-sensitive drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Drug container
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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-HP

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DILAUDID-HP

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2010064074 ⤷  Try a Trial
Australia 2018236914 PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS ⤷  Try a Trial
Spain 2359657 ⤷  Try a Trial
Mexico PA02004678 COMPOSICIONES DE HIDROCODEINONA E HDROMORFINONA Y METODOS PARA SU SINTESIS. (HYDROMORPHINONE AND HYDROCODEINONE COMPOSITIONS AND METHODS FOR THEIR SYNTHESIS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.