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Generated: April 28, 2017

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NALOXONE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for naloxone hydrochloride and what is the scope of freedom to operate?

Naloxone hydrochloride
is the generic ingredient in seven branded drugs marketed by Abraxis Pharm, Marsam Pharms Llc, Bristol Myers Squibb, Adapt, Mylan Institutional, Intl Medication, Watson Labs, Hospira, Kaleo Inc, Akorn, Smith And Nephew, Eurohlth Intl Sarl, Solopak, Astrazeneca, Igi Labs Inc, Wyeth Ayerst, West-ward Pharms Int, Purdue Pharma Lp, Sun Pharm Inds Ltd, Sanofi Aventis Us, and Gavis Pharms, and is included in sixty-three NDAs. There are forty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride has one hundred and thirty-six patent family members in seventeen countries.

There are twelve drug master file entries for naloxone hydrochloride. Sixteen suppliers are listed for this compound.

Summary for Generic Name: NALOXONE HYDROCHLORIDE

Tradenames:7
Patents:48
Applicants:21
NDAs:63
Drug Master File Entries: see list12
Suppliers / Packagers: see list16
Bulk Api Vendors: see list49
Clinical Trials: see list1,074
Patent Applications: see list6,709
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:NALOXONE HYDROCHLORIDE at DailyMed

Pharmacology for Ingredient: NALOXONE HYDROCHLORIDE

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adapt
NARCAN
naloxone hydrochloride
INJECTABLE;INJECTION016636-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe
Kaleo Inc
EVZIO
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes9,278,182► SubscribeY ► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNNoNo9,522,919► SubscribeYY ► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-002Jul 23, 2014DISCNNoNo9,522,919► SubscribeYY ► Subscribe
Kaleo Inc
EVZIO
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes7,947,017► SubscribeY ► Subscribe
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