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Last Updated: March 19, 2024

HYDROMORPHONE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Hydromorphone Hydrochloride, and what generic alternatives are available?

Hydromorphone Hydrochloride is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Genus, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc. and is included in twenty-three NDAs.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydromorphone Hydrochloride

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

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Drug patent expirations by year for HYDROMORPHONE HYDROCHLORIDE
Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE

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SponsorPhase
University of MiamiPhase 2
Johns Hopkins UniversityEarly Phase 1
Qianfoshan HospitalPhase 4

See all HYDROMORPHONE HYDROCHLORIDE clinical trials

Pharmacology for HYDROMORPHONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for HYDROMORPHONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROMORPHONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for HYDROMORPHONE HYDROCHLORIDE
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 Tablets hydromorphone hydrochloride 2 mg, 4 mg, and 8 mg 019892 1 2013-08-05
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
DILAUDID Oral Solution hydromorphone hydrochloride 5 mg/5mL 019891 1 2011-02-25
EXALGO Extended-release Tablets hydromorphone hydrochloride 8 mg and 12 mg 021217 1 2010-09-02
EXALGO Extended-release Tablets hydromorphone hydrochloride 16 mg 021217 1 2010-08-02

US Patents and Regulatory Information for HYDROMORPHONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genus HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077471-001 Dec 9, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278-004 Sep 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-003 Sep 19, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nesher Pharms HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077311-002 Nov 9, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-001 Dec 23, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Osmotica Pharm Us HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-004 Jul 7, 2016 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 210506-001 Jan 17, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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