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Generated: April 28, 2017

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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

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

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
naloxone hydrochloride
INJECTABLE;INJECTION016636-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe
Kaleo Inc
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes9,278,182► SubscribeY ► Subscribe
Purdue Pharma Lp
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNNoNo9,522,919► SubscribeYY ► Subscribe
Purdue Pharma Lp
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-002Jul 23, 2014DISCNNoNo9,522,919► SubscribeYY ► Subscribe
Kaleo Inc
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes7,947,017► SubscribeY ► Subscribe
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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. thinkBiotech performs no independent verifification 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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