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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilaudid

A generic version of DILAUDID was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

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Summary for DILAUDID

International Patents:	22
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	102
Patent Applications:	3,559
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DILAUDID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILAUDID
What excipients (inactive ingredients) are in DILAUDID?	DILAUDID excipients list
DailyMed Link:	DILAUDID at DailyMed

Drug patent expirations by year for DILAUDID

Recent Clinical Trials for DILAUDID

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

Sponsor	Phase
University of Miami	Phase 2
The Cleveland Clinic	N/A
Hennepin Healthcare Research Institute	Phase 4

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Pharmacology for DILAUDID

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DILAUDID

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	AP	RX	Yes	Yes	⤷ 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
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	SOLUTION;ORAL	019891-001	Dec 7, 1992	AA	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ 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	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	AP	RX	Yes	Yes	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	SOLUTION;ORAL	019891-001	Dec 7, 1992	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009	⤷ Try a Trial	⤷ Try a Trial
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-002	Nov 9, 2007	⤷ Try a Trial	⤷ Try a Trial
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-003	Nov 9, 2007	⤷ Try a Trial	⤷ Try a Trial
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-001	Dec 7, 1992	⤷ Try a Trial	⤷ Try a Trial
>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.

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

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