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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

DILAUDID-HP Drug Profile

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in fifteen 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.

Summary for DILAUDID-HP
International Patents:39
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 18
Clinical Trials: 87
Formulation / Manufacturing:see details
DailyMed Link:DILAUDID-HP at DailyMed
Drug patent expirations by year for DILAUDID-HP
Recent Clinical Trials for DILAUDID-HP

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

SponsorPhase
Hennepin Healthcare Research InstitutePhase 4
State University of New York at BuffaloPhase 3
Duke UniversityPhase 3

See all DILAUDID-HP clinical trials

Pharmacology for DILAUDID-HP
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for DILAUDID-HP
Tradename Dosage Ingredient NDA Submissiondate
DILAUDID-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22
DILAUDID-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22

US Patents and Regulatory Information for DILAUDID-HP

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   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Medtronic
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Mallinckrodt
Merck

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