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Naloxone hydrochlorideis 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
|Drug Master File Entries:||12|
|Suppliers / Packagers:||18|
|Bulk Api Vendors:||46|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for naloxone hydrochloride|
|What excipients (inactive ingredients) are in naloxone hydrochloride?||naloxone hydrochloride excipients list|
|DailyMed Link:||naloxone hydrochloride at DailyMed|
Recent Clinical Trials for naloxone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Trustees of Dartmouth College||Early Phase 1|
|Columbia University||Phase 1|
|Go Medical Industries Pty Ltd||Phase 1|
Generic filers with tentative approvals for NALOXONE HYDROCHLORIDE
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 Class||Opioid Antagonist |
|Mechanism of Action||Opioid Antagonists |
Medical Subject Heading (MeSH) Categories 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|
|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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