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-four NDAs.
The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen 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.
Summary for HYDROMORPHONE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 15 |
NDAs: | 24 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 26 |
Clinical Trials: | 301 |
Patent Applications: | 1,901 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HYDROMORPHONE HYDROCHLORIDE |
What excipients (inactive ingredients) are in HYDROMORPHONE HYDROCHLORIDE? | HYDROMORPHONE HYDROCHLORIDE excipients list |
DailyMed Link: | HYDROMORPHONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Miami | Phase 2 |
Johns Hopkins University | Early Phase 1 |
Qianfoshan Hospital | Phase 4 |
Pharmacology for HYDROMORPHONE HYDROCHLORIDE
Drug Class | Opioid Agonist |
Mechanism of Action | Full 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 |