Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202159


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NDA 202159 describes HYDROMORPHONE HYDROCHLORIDE, which 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, Mpp Pharma, Nesher Pharms, and Specgx Llc, and is included in twenty-four NDAs. It is available from thirteen suppliers. There is one patent protecting this drug. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 202159
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Hikma
Ingredient:hydromorphone hydrochloride
Patents:0
Pharmacology for NDA: 202159
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 202159
Analgesics, Opioid
Narcotics
Suppliers and Packaging for NDA: 202159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 202159 ANDA Hikma Pharmaceuticals USA Inc. 0641-6151 0641-6151-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Apr 27, 2018TE:APRLD:No

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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