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Last Updated: May 27, 2022

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. Seventeen 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
The Cleveland ClinicN/A
Hennepin Healthcare Research InstitutePhase 4
State University of New York at BuffaloPhase 3

See all DILAUDID clinical trials

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Drug container
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rhodes Pharms DILAUDID hydromorphone hydrochloride SOLUTION;ORAL 019891-001 Dec 7, 1992 See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-003 Apr 30, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DILAUDID

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

Country Patent Number Title Estimated Expiration
Mexico PA02004678 COMPOSICIONES DE HIDROCODEINONA E HDROMORFINONA Y METODOS PARA SU SINTESIS. (HYDROMORPHINONE AND HYDROCODEINONE COMPOSITIONS AND METHODS FOR THEIR SYNTHESIS.) See Plans and Pricing
China 204798475 See Plans and Pricing
World Intellectual Property Organization (WIPO) 0134608 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Moodys
Johnson and Johnson
Harvard Business School
Colorcon

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.