DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
« Back to Dashboard
Naloxone hydrochlorideis the generic ingredient in nine branded drugs marketed by West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Akorn, Astrazeneca, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, 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, Hikma, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in seventy-four NDAs. There are fifty-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 eighty-three patent family members in eighteen countries.
There are twelve drug master file entries for naloxone hydrochloride. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for naloxone hydrochloride
|Drug Master File Entries:||12|
|Finished Product Suppliers / Packagers:||20|
|Raw Ingredient (Bulk) Api Vendors:||48|
|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
|Stephanie B. Seminara, MD||Phase 2|
|Stephanie B. Seminara, MD||Phase 1|
|University of Maryland, Baltimore||Phase 1/Phase 2|
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
Anatomical Therapeutic Chemical (ATC) Classes 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|
|Purdue Pharma Lp||TARGINIQ||naloxone hydrochloride; oxycodone hydrochloride||TABLET, EXTENDED RELEASE;ORAL||205777-002||Jul 23, 2014||DISCN||Yes||No||⤷ Free Forever Trial||⤷ Free Forever Trial||Y||⤷ Free Forever Trial|
|Sanofi Aventis Us||TALWIN NX||naloxone hydrochloride; pentazocine hydrochloride||TABLET;ORAL||018733-001||Dec 16, 1982||DISCN||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Kaleo Inc||EVZIO||naloxone hydrochloride||SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS||205787-001||Apr 3, 2014||DISCN||Yes||No||⤷ Free Forever Trial||⤷ Free Forever Trial||Y||⤷ Free Forever 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||⤷ Free Forever 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|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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 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.