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Last Updated: June 6, 2020

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DILAUDID Drug 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 three patents protecting this drug and four Paragraph IV challenges.

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

Paragraph IV (Patent) Challenges for DILAUDID
Tradename Dosage Ingredient NDA Submissiondate
DILAUDID TABLET;ORAL hydromorphone hydrochloride 019892 2013-08-05
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID-HP 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
DILAUDID SOLUTION;ORAL hydromorphone hydrochloride 019891 2011-02-25

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 019034-006 Jan 16, 2020 RX Yes Yes   Start Trial   Start Trial   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 hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-003 Apr 30, 2009 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-003 Nov 9, 2007 AB RX Yes No   Start Trial   Start Trial Y 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:

AstraZeneca
Express Scripts
Moodys
Johnson and Johnson
Harvard Business School
Colorcon

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