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Last Updated: March 8, 2021

DrugPatentWatch Database Preview

Naloxone hydrochloride - Generic Drug Details

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What are the generic sources for naloxone hydrochloride and what is the scope of patent protection?

Naloxone hydrochloride is the generic ingredient in eight branded drugs marketed by West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Akorn, Astrazeneca, Aurobindo Pharma Ltd, Dr Reddys, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Par Sterile Products, Smith And Nephew, Solopak, Somerset Theraps Llc, Virtus Pharms, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Teva Pharms Usa, Emergent, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in seventy-one NDAs. There are fifty-five 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 seventy patent family members in eighteen countries.

There are twelve drug master file entries for naloxone hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for naloxone hydrochloride
Recent Clinical Trials for naloxone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Trustees of Dartmouth CollegeEarly Phase 1
Columbia UniversityPhase 1
Go Medical Industries Pty LtdPhase 1

See all naloxone hydrochloride clinical trials

Generic filers with tentative approvals for NALOXONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial4MG/SPRAYSPRAY, METERED;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for naloxone hydrochloride
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for naloxone hydrochloride
Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
NARCAN SPRAY, METERED;NASAL naloxone hydrochloride 208411 2017-12-28
NARCAN SPRAY, METERED;NASAL naloxone hydrochloride 208411 2016-07-15

US Patents and Regulatory Information for naloxone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072090-001 Apr 11, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072085-001 Apr 11, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-002 Jul 23, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Hospira NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070257-001 Jan 7, 1987 AP RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for naloxone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Medtronic
McKesson
Merck
McKinsey

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